Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Chronic Disease

Head and Neck Neoplasms

Chronic Graft Versus Host Disease

Head and neck cancer patients monitored on registry

Patients who are diagnosed with head and neck cancer and monitored by the Otolaryngology - Head and Neck Surgery clinic at Zuckerberg San Francisco General Hospital and Trauma Center will be included in this group. The intervention is the implementation of a registry, designed to replace existing paper-based systems for tracking patients. All head and neck cancer patients monitored by the clinic will be included.

Registry

Urmimala Sarkar, MD, MPH

To implement and evaluate a health information technology platform designed to support the management of patients with head and neck cancer in an urban, publicly-funded outpatient setting. This is an observational study; researchers will not assign specific interventions to study participants.

The investigators aim to implement and evaluate a health information technology (HIT) registry at an urban, public delivery system. The investigators will not assign specific interventions to the study participants, but rather observationally assess the effect of the HIT registry, designed to support routine medical care, on participants.

The investigators will use systems engineering methodologies to design, develop, and implement the platform. The platform will be implemented in the Otolaryngology - Head and Neck Surgery clinic that cares for patients with head and neck cancers. The study will assess patient outcomes and evaluate the time it takes for patients to progress through key treatment and post-treatment milestones before and after the HIT tool is implemented. The investigators will use models controlling for secular trend to estimate the effect of the tool on improving timely and successful completion of guideline-based care processes.

The HIT platform seeks to improve the monitoring and alerting functionality of existing systems. Specifically, it replaces paper-based systems previously used by the clinic to monitor its head and neck cancer patients. It will be implemented clinic-wide for all patients being treated for head and neck cancers. The investigators are not assigning a specific intervention to patients, but rather supporting the clinic and health system in the development of a population management platform that improves routine care processes. The platform is approved for clinical use and research by the San Francisco Health Network and the University of California, San Francisco.

The HIT platform users are clinicians who are responsible for monitoring patients with head and neck cancer and agree to partner with the investigators to improve monitoring processes. The clinicians involved may be asked to voluntarily participate in surveys, interviews, focus groups, and program evaluations. Patient medical records will be reviewed, but patients monitored on the registry will not be contacted by researchers.

Procedures are in place to monitor the registry. First, quality assurance is performed by the research team, information technology analysts, and software engineers. This includes checking that data in the platform matches source data, such as data entered in the electronic health record. In addition, the platform users are audited on a weekly basis. A data dictionary defining variables used in the platform exists and is updated as needed. Patients will be added to the registry by a clinician if they are diagnosed with head and neck cancer. The research team will support the clinicians in data analysis, although this will be performed with population-level, de-identified data. However, if unmediated adverse events are identified by the research team, the research team will alert the clinicians immediately. The HIT platform is designed to supplement, but not replace, the existing electronic health record. Data on the registry will be validated with source data and users will still engage with the source data and electronic health record as appropriate clinically and operationally.

Customized Registry Tool for Tracking Adherence to Clinical Guidelines for Head and Neck Cancers

Time from diagnosis to initiation of treatment

Proportion of patients that complete tumor board treatment recommendations

Time from diagnosis to presentation at tumor board

Time from diagnosis to first visit in oncology clinics

Proportion of patients who complete post-treatment radiation

Proportion of patients who are lost to follow-up

Agency for Healthcare Research and Quality (AHRQ)

University of California, San Francisco

Acute Graft Versus Host Disease

machine learning directed identification of chemotherapy patients at high-risk for emergency department acute care and/or hospitalization

Machine learning algorithm

Manisha Palta, MD

The objective of this study is to apply a validated machine-learning based model (SHIELD-RT, NCT04277650) to a cohort of patients undergoing systemic therapy as outpatient cancer treatment to generate an automatic system for the prediction of unplanned hospital admission rates and emergency department encounters.

A previously described machine learning (ML)-based model accurately predicted ED visits or hospitalizations for cancer patients undergoing radiation therapy or chemoradiation. An IRB approved prospective randomized trial, SHIELD-RT (NCT04277650) found that preemptive intervention for patients undergoing radiation and chemoradiation based on the ML model's risk stratification decreased the relative risk of acute care visits by 50%, showing that ML-guided escalation of care improved personalized supportive care and treatment compliance while decreasing healthcare costs.

The objective of this study is to apply this validated ML based model to a cohort of patients undergoing systemic therapy as outpatient cancer treatment to generate an automatic system for the prediction of unplanned hospital admission rates and emergency department encounters. Once validated, this study will add to the previously published body of evidence supporting a randomized trial evaluating the ML algorithm's ability to assign intervention for patients receiving systemic therapy at highest risk for acute care encounters.

Machine Learning to Predict Acute Care During Cancer Therapy

Generalizable Machine Learning to Predict Acute Care During Outpatient Systemic Cancer

Duke University

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Patients received CAR-T infusion in IP setting

Patients received CAR-T infusion in OP setting

Patients received allogeneic hematopoietic stem cell transplant

infusion of CAR-T therapy among patients with r/r DLBCL

CAR-T

Allo-HSCT cohort

Novartis Pharmaceuticals

A retrospective, non-interventional cohort study was used to address the study objectives. This study aimed to provide a better understanding of real-world healthcare resource utilization (HRU) and healthcare reimbursement costs associated with CAR-T therapy among patients with r/r Diffuse Large B-cell Lymphoma (DLBCL).

A retrospective, non-interventional cohort study was used to address the study objectives. This study aimed to provide a better understanding of real-world HRU and healthcare reimbursement costs associated with CAR-T therapy among patients with r/r DLBCL.

Eligible adult patients with r/r DLBCL who were treated with CAR-T therapy or allo-HSCT between January 1, 2017 to September 31, 2019 were identified from the Centers for Medicare \& Medicaid Services (CMS) 100% Medicare Database. The CAR-T cohort was further classified into CAR-T IP and CAR-T OP cohorts based on the infusion setting.

The index date was defined as the date of CAR-T therapy administration or allo-HSCT. Baseline period was defined as three months prior to the index date. Study period was defined from the index date to the end of health plan coverage based on insurance enrollment file or death, whichever occurred earlier.

Two sets of comparisons on HRU and healthcare reimbursement costs were conducted, one between IP vs. OP infusion of CAR-T, and the other between patients who received CAR-T therapy vs. allo-HSCT.

Real-world Resource Use and Costs of CAR-T Therapies in Diffuse Large B-cell Lymphoma (DLBCL)

Real-world Resource Use and Costs of CAR-T Therapies in Diffuse Large B-cell Lymphoma (DLBCL): Inpatient and Outpatient Settings

Mean length of follow up was reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.

Number of patients with IP visit were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.

Number of IP admissions were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.

Number of ICU stays were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.

Number of ICU days were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.

Number of patients with OP visit were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.

Number of OP visits were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.

Number of patients with ER visit were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.

Number of ER visits were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.

Total healthcare reimbursement costs, including medical service costs and pharmacy costs, inflated to 2020 US dollars (USD) were reported in CAR-T IP and CAR-T OP cohorts.

Mean length of follow up was reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.

Number of patients with IP visit were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.

Number of IP admissions were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.

Number of IP days were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.

Number of ICU stays were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.

Number of ICU days were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.

Number of patients with OP visit were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.

Number of OP visits were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.

Number of patients with ER visit were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.

Number of ER visits were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.

IP re-admission/admission were reported to assess post-infusion IP admission/readmission among patients with r/r DLBCL who received CAR-T therapy.

Rate of adverse events (AEs) were reported among patients with r/r DLBCL who received CAR-T therapy.

Cost per AE event were reported among patients with r/r DLBCL who received CAR-T therapy.

Total healthcare reimbursement costs, including medical service costs and pharmacy costs, defined as the amount paid by Medicare, inflated to 2020 USD were reported in overall CAR T and allo-HSCT cohorts.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transurethral bladder tumor resection in operating theatre as inpatient.

Outpatient laser mediated destruction of bladder tumors (LMD-BT)

Conventional bladder tumor resection using diathermia

Bladder tumor resection using diathermia

Laser mediated destruction of bladder tumors (LMD-BT)

Diode laser (980 nm) tumor destruction

Gregers G Hermann, DM Sc

Gregers G Hermann, MD

This study compare the efficacy of conventional photodynamic (PDD) guided transurethral bladder tumor resection in the operating theatre with outpatient PDD guided laser destruction of bladder tumors through flexible cystoscopes.

A prospective randomized two-part clinical trial comprising patients with recurrent pTa low grade bladder tumors.

Study objectives and purpose:

* 1st Objective: To evaluate whether small pTa bladder tumours can be removed with diode laser in an outpatient department with similar efficacy as by TUR-BT resection in the operating theatre.
* 2nd Objective: To evaluate the patients experience of symptoms during laser treatment in the outpatient department (OPD) using quality of life (QOL) questionnaires (symptom evaluation) and Visual Analog Scale Score (pain evaluation).
* 3rd Objective: To evaluate whether patients prefer standard transurethral bladder tumor resection (TUR-BT) in the operating theatre (OT) or laser treatment in the OPD.
* 4th Objective: To evaluate the safety after laser treatment in the OPD.

Efficacy:

* 1st Endpoint: Proportion of patients with no tumor tissue in the bladder after 4 months and 12 months.
* 2nd Endpoint: Visual Analog Scale Score (pain evaluation) in patients having tumor removed by laser in the OPD.

General urinary problems and QOL one week after the laser treatment. The Danish validated questionnaire (QLQ- BLS24) from EORTC will be used.

* 3rd Endpoint: Patients preference for either OPD laser treatment procedure or TUR-BT in the OT as inpatient procedure.
* 4th Endpoint: Character and severity of adverse events in relation to the outpatient treatment.

Study

Inclusion criteria:

1. Ta low grade bladder tumor recurrences
2. Up to a tumor size of 1,5 cm
3. Up to 6 tumors
4. Eligible patients for TUR-BT

Exclusion criteria:

1. Patients with porphyria
2. Known hypersensitivity to Hexvix® or porfhyrins
3. Use of concomitant anticoagulants as Marevan, Marcoumar, and Pradaxa
4. Dementia
5. Macroscopic hematuria
6. Pregnant or breast feeding women
7. Expected poor compliance estimated by the investigators
8. Patients \< 18 years
9. Patients who do not read or understand Danish

Outpatient PDD Guided Laser Mediated Destruction of Bladder Tumors

Is Outpatient PDD Guided Laser Mediated Destruction of Bladder Tumors (LMD-BT) as Good as Conventional Inpatient PDD Guided Transurethral Tumor Resection in Patients With Low Grade Non-invasive (Ta) Bladder Tumors?

Numbers (%) of patients vith histological proven recurrence of bladder tumor after 4 months

Using the EORTC questionnaire QLQ-BLS24 the extent of symptoms are given on a unique score from 0-100, with 0 being no symptoms and 100 are worst symptoms. Mean and range score in the two arms will be compared statistically.

Symptoms measured by one unique score according to the Clavien-Dindo grading system. Mean and range score in the two arms will be compared statistically.

The patients record pain on a visual analogue scale of 0-10. Zero corresponds to no pain. Ten correspond to the worst possible pain.

University Hospital Bispebjerg and Frederiksberg

Consultant Urologist

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Cytarabine

Daunorubicin

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

The study intervention is the application of a prescribed outpatient care model including a nurse teacher educational program and quality of life surveys for both subjects and caregivers. Induction therapy and medical follow up are performed without prophylactic admission to an inpatient facility. Subjects will also receive CPX-351 according to FDA approval, to subjects who meet medical and logistical criteria for study enrollment.

Outpatient care model includes a nurse teacher educational program, scheduled outpatient visit protocol, and quality of life surveys for both subjects and caregivers.

Outpatient Care Model

CPX-351 is administered, according to FDA approval, to subjects who meet medical and logistical criteria for study enrollment.

CPX-351

Laura Michaelis, MD

This is a single-arm, single-site run-in phase (six subjects) followed by a multicenter continuation phase (114 subjects), Phase IV study. Eligible subjects will be receiving CPX-351 as their usual medical care administered according to FDA approval, as a condition for participation.

This is an open-label, non-randomized study of a non-drug intervention in subjects receiving CPX-351 as their usual medical care administered according to its FDA approval. The study intervention is the application of a prescribed outpatient care model, including a nurse teacher educational program and quality of life surveys for both subjects and caregivers, in subjects who meet medical and logistical criteria. Induction therapy and medical follow-up are performed without prophylactic admission to an inpatient facility.

Patients Receiving Induction With Liposomal Daunorubicin and Cytarabine (CPX-351) for Acute Myeloid Leukemia

The Feasibility of Safely Managing Patients Receiving Induction With Liposomal Daunorubicin and Cytarabine (CPX-351) for Acute Myeloid Leukemia (AML) in an Outpatient Environment

This measure will record the number subjects who adhere to outpatient follow-up appointments and readmission recommendations. Subjects completing 95% of their recommended outpatient visits will be considered to be adherent to the recommendations.

This measure will record the number of subjects who complete as 100% compliance with medical provider recommendations to be admitted to the hospital (except for reasons of adopting a palliative or hospice approach to care). Subjects not achieving a 100% rate of compliance will be considered non-adherent to the recommendations.

Medical College of Wisconsin

Associate Professor

The study intervention is the application of a prescribed outpatient care model including a nurse teacher educational program and quality of life surveys for both subjects and caregivers. Induction therapy and medical follow up are performed without prophylactic admission to an inpatient facility. Subjects will also receive CPX-351 according to FDA approval, to subjects who meet medical and logistical criteria for study enrollment.

Outpatient Care Model: Outpatient care model includes a nurse teacher educational program, scheduled outpatient visit protocol, and quality of life surveys for both subjects and caregivers.

CPX-351: CPX-351 is administered, according to FDA approval, to subjects who meet medical and logistical criteria for study enrollment.

Intervention

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Number of Participants Adherent to Recommendations

Number of Participants Adherent to Readmission Recommendations

Overall Study

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Use of the EndoVe device to safely and effectively ablate rectal tumor tissue

The EndoVe device enables the endoscopic treatment of gastrointestinal tumor tissues. The device is placed on the tumor tissue and an electrical pulse of less than 1msec is delivered. The tumor tissue becomes permeabilised and absorbs much greater concentrations of the drug than the surrounding healthy tissue

EndoVe endoscopic electroporation

A new approach to treating solid tumours (both operable and inoperable) has been carried out by the Cork Cancer Research Centre (CCRC) at the Mercy University Hospital, Cork, Ireland since 2002.

The approach simply allows a greater concentration of chemotherapy drugs to enter the tumour cells rather than healthy cells. The uptake of the chemotherapeutic drug directly by the tumour is aided through applying short electric pulses to the tumor mass (referred to as - Electrochemotherapy or ECT). The pulses make the tumour more porous which allows the drug easier access into the cancer cells, whereas other tissues and organs in the body remain relatively poor at absorbing the drug, thereby reducing the potential side effects on healthy tissues. This approach to date has been limited to skin based tumours due to the requirement for the electrodes to be placed directly in contact with the tumour. Procedures with electrochemotherapy have been applied to human patients in other countries of the EU, the US and Japan.

The drug concentration used is significantly reduced due to the more targeted absorption by the tumor and this significantly reduces side effects normally associated with chemotherapy.

A large number of preclinical and clinical Phase I and I/II studies have demonstrated the efficiency and safety of ECT. These studies have included patients with melanoma, head and neck squamous cell carcinoma, merkel cell carcinomas, basal cell carcinoma and adenocarcinoma nodules. Case reports concerning other primary tumours have also been reported.

The investigators have developed an endoscopic approach (EndoVe system) for delivering the electric pulses to internal cancers and are currently seeking to evaluate its efficacy in the treatment of inoperable colorectal cancer. The treatment procedure is similar to standard endoscopic colorectal examination (colonoscopy) with the added element of an intravenous injection of bleomycin followed after eight minutes by the delivery of electric pulses (each one less than 1msec in duration). The pulses are endoscopically delivered directly to the tumour mass. The entire procedure is minimally invasive and does not require intensive care follow up or stitches. If the treatment is successful the tumour will shrink in size in the weeks following the procedure.

The objective of this study is to investigate the efficacy and safety of this approach in reducing the size of the tumour.

The objective is to conduct treatment in a minimally invasive manner (using the endoscope) and without the requirement for repeated doses of chemotherapy. The single dose of the drug used (15,000 IU/m2 x Body Surface Area of bleomycin) has been well tolerated in all patients treated previously with this approach to skin based cancers (in excess of 300 treatments since 2003 in our hospital). Therefore, it is anticipated that patients are unlikely to suffer side effects from the low concentration of drug used.

There are no known side effects of the instrument being tested. The pulse generator used has been certified by European electrical safety bodies charged with assessing compliance of new equipment with the present security rules for electrical devices. The electrical pulse generator has the CE mark and is approved for use clinically; the endoscopic electrodes used are a prototype system and are not currently CE approved.

The treatment is provided on an outpatient basis and does not involve an overnight stay. The procedure is very similar to a colonoscopy examination with the added element of a low dose chemotherapy drug being injected intravenously.

It reduces operative time; therefore there are fewer anaesthetic risks

At this time, the only option for patients with inoperable colorectal cancers is symptom relief e.g. a defunctioning colostomy or stent placement. Both carry a risk profile greater than the treatment with the EndoVe system.

Quicker recovery time- This is beneficial for the patient in terms of reduced exposure to the hospital environment through a shorter in-patient stay.

Research: The potential benefits of studying novel medical instruments in general include the development of new alternatives to conventional or existing therapies for certain cancers. In particular, the widespread availability of the novel instrument being tested here may lessen the requirement for more invasive procedures. It will reduce the amount of chemotherapy drug being used, therefore reducing the systemic effects as well as the side effects.

The approach is currently being applied to inoperable cases but in the future it may potentially be applied to both earlier stage cancers and other internal cancers e.g. oesophagus, stomach etc.

Because the treatment procedure is short (outpatient basis), it allows these patients greater time outside of the hospital environment to maximise and allowing for a greater quality of life (this for both individual patient and community at large).

If this treatment approach is proven to be safe and effective, patients with inoperable colorectal cancers will have a minimally invasive option for palliation of symptoms.

Endoscopic Treatment of Inoperable Colorectal Cancer With the EndoVe System

Treatment of Inoperable Colorectal Cancer With Electrochemotherapy Through an Endoscopic System

Follow up examination of tumor volume following treatment via endoscopy and transrectal ultrasound.

Evaluate safety of treatment approach at regular checkup intervals following treatment

St. James's Hospital, Ireland

The Adelaide and Meath Hospital

Mercy University Hospital, Cork, Ireland

Principal Investigator

Thrombocytopenia

Syndrome

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Precancerous Conditions

Patients allocated to the therapeutic platelet transfusion group will not receive routine prophylactic platelet transfusions.

Patients allocated to the prophylactic platelet transfusions will receive a platelet transfusion (a single dose of random donor platelets (4 unit pool or random donor platelets or one apheresis unit) when the measured platelet count is \< 10 x 109/L.

Patients allocated to the therapeutic platelet transfusion group will not receive routine prophylactic platelet transfusions. Platelet transfusions will be given to treat documented clinically relevant bleeding defined as WHO bleeding of grade 2 or greater. Patients may be transfused at the discretion of the treating physician. The indication for all platelet transfusions will be recorded by asking the ordering physician.

Patients allocated to the prophylactic platelet transfusions will receive a platelet transfusion when the measured platelet count is \< 10 x 109/L. Patients may receive additional platelet transfusions at the discretion of the treating physician. The indication for all platelet transfusions will be recorded.

Platelet Transfusion

Alan Tinmouth, MD, MSc

As a result of the underlying disease or its therapy, it is common for patients with blood cancers to have low platelet counts. While platelet transfusions may be beneficial in preventing or treating bleeding symptoms, in circumstances where the risk of bleeding is low they may be unnecessary or even harmful. As a blood product, transfusion of platelets may be associated with infectious or allergic complications, and frequent hospital visits for transfusion may adversely affect quality of life. Additionally, the potentially overuse of platelet products places a burden on health care resources.

The benefit of the current practice of prophylactic platelet transfusions to prevent hemorrhage is unknown. The randomized data that exists is more than 25 years old and not informative given methodological limitations and the changing standards of supportive care. An alternative, therapeutic, strategy involves only administering platelets to control active bleeding.

The standard of practice in inpatients receiving high dose chemotherapy (either for acute leukemia or as part of stem cell transplantation) is prophylactic platelet transfusions. In outpatients not receiving high dose chemotherapy, the risk of bleeding is significantly lower. No randomized trials have examined the optimal platelet transfusion strategy in outpatients with blood cancers undergoing supportive or palliative therapy. Thus the potential benefit of prophylactic transfusions in the outpatient setting is unknown.

The investigators propose to perform a pilot randomized controlled trial to determine if a larger trial is possible. The ultimate goal is to determine if a strategy of therapeutic platelet transfusions is safe and effective in outpatients with blood cancers and low platelet counts.

Randomization:

A local study nurse will use a web-based randomization system (permuted random blocks of two or four patients) to allocate consenting patients. Medical and research staff and investigators will be blinded to randomization scheme.

Study Duration and Follow-up:

All patients will be assigned to either a therapeutic or prophylactic platelet transfusion for a 6-month period. This period of time will allow us to assess our primary feasibility outcomes of enrollment, compliance with transfusion protocols, and completion of bleeding evaluations and quality of life questionnaires by patients.

Patients in both groups will have their CBC measured at least weekly while on study. More frequent monitoring of the platelet count may be performed at the discretion of the treating physician. The research team will clinically assess patients within 1 week (+/- 3 days) of randomization, and monthly thereafter. Patients will be asked to report any non-cutaneous grade 2 or greater bleeding immediately to their treating physicians and the study team. All the self-assessments of bleeding will be reviewed at each patient visit to ensure that all clinically relevant bleeding episodes have been captured.

Patients whose platelet count recovers to greater than 20 x 109/L for at least six weeks will be taken off the weekly platelet count monitoring as reflects clinical practice. They will continue to be monitored for the duration of the study. If their platelet count falls to 10 x 109/L or below then they will be restarted on the monitoring and previous transfusion protocol.

Data Collection:

Baseline Data - The following clinical and laboratory data will be collected at the time of enrolment: (1) demographic data, (2) diagnosis including date and disease stage, (3) prior chemotherapy, (4) ECOG performance status, (5) comorbidites, (6) previous platelet and red cell transfusions, (7) red cell transfusion history, (8) prior bleeding events, (9) quality of life (EQ5D) (10) routine bloodwork

Transfusions:

All platelet and red cell transfusions will be recorded including date and number of units. For platelet transfusions, the type of platelet product (e.g. apheresis or buffy coat) and ABO compatibility will recorded. Additionally, the indication for all transfusions (prophylactic or to treat bleeding) will be obtained from the attending physician.

Bleeding Assessment:

Participants will be asked to complete a simple bleeding questionnaire on a daily basis which has been previously tested and used in outpatients with thrombocytopenia. Patients will receive a short training session and written material on how to complete the form. A bleeding assessment will be performed at all study follow-up visits (interview, physical exam and review of daily bleeding forms). Bleeding events will be assigned a bleeding grade by the study personnel. A final bleeding grade will be assigned by an adjudication panel of 2 blinded physicians who will independently assign bleeding scores. Any discrepancies in bleeding scores will be resolved by consensus.

Quality of Life:

Quality of life will be measured using the EQ-5D. The EQ-5D is a validated tool for measurement of health-related quality of life there is a precedent for its use in transfusion medicine trials. Quality of life assessments will be performed at baseline and at all subsequent patient visits.

Outpatient Platelet Transfusions in Myelodysplastic Syndromes and Leukemia: The OPTIMAL Pilot

Overall enrollment, off protocol transfusions per each randomized group, total number of platelet transfusions per group and patient compliance with daily self assessment of bleeding will be evaluated.

Assessments will include:

1. Non-cutaneous Grade 2 bleeding or higher by the World Heath Organization (WHO) bleeding assessment scale 28(Appendix B)
2. Grade 3 bleeding or higher
3. Time from randomization to first bleeding event of grade 3 of higher
4. Total number of red cell transfusion per group
5. Total number of hospital days per group
6. Number of completed daily bleeding assessments per group
7. Quality of life
8. Mortality

Canadian Blood Services

Canadian Institutes of Health Research (CIHR)

Ottawa Hospital Research Institute

Prostatic Neoplasms

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Patients who elect to be monitored by an Active Surveillance protocol for prostate cancer

Patients who are diagnosed with prostate cancer and elect to be monitored by an Active Surveillance protocol by the Urology Clinic at Zuckerberg San Francisco General Hospital and Trauma Center will be included in this group. The intervention is the implementation of a registry, designed to replace existing but suboptimal systems for tracking patients. All Active Surveillance patients monitored by the clinic will be included.

To implement and evaluate a health information technology platform designed to support the management of patients on active surveillance for prostate cancer in an urban, publicly-funded outpatient setting.

We aim to implement and evaluate a health information technology (HIT) registry at an urban, public delivery system. We will use systems engineering methodologies to design, develop, and implement the platform. The platform will be implemented in the Urology clinic that cares for patients with prostate cancer. We are conducting a prospective non-randomized pilot study that will follow men who choose active surveillance as a management strategy for prostate cancer. We aim to assess the impact of the HIT registry on patient monitoring and adherence.

The HIT platform seeks to improve the monitoring and alerting functionality of existing systems. Specifically, it replaces paper-based or ineffective computer-based systems previously used by the clinic to monitor its active surveillance patients. It will be implemented clinic-wide for all patients being monitored by an active surveillance protocol. The platform is approved for clinical use and research by the San Francisco Health Network and the University of California, San Francisco.

Research involves materials that are collected for nonresearch purposes, as well as low-risk research employing survey, interview, focus group, program evaluation, and human factors methodologies. We will solicit structured feedback from registry users designed to continuously evaluate and improve performance in a clinical area to reduce patient safety gaps. Patient medical records will be reviewed, but patients monitored on the registry will not be contacted by researchers.

Procedures are in place to monitor the registry. First, quality assurance is performed by the research team, information technology analysts in the San Francisco Health Network, as well as by the third-party software provider. This includes checking that data in the platform matches source data, such as data entered in the electronic health record. In addition, users are audited on a weekly basis. A data dictionary defining variables used in the platform exists and is updated as needed. The HIT platform users include clinicians who are responsible for monitoring patients on active surveillance for prostate cancer. Patients who are enrolled in the active surveillance program will be added to the registry by a clinician. The research team will support the clinicians in data analysis, although this will be performed with population-level, de-identified data. However, if unmediated adverse events are identified by the research team, the research team will alert the clinicians appropriately. The research team will also develop training materials and conduct training sessions to ensure that all clinicians responsible for monitoring patients on active surveillance are provided with up-to-date resources and accessible support. The HIT platform is designed to supplement, but not replace, the existing electronic health record. Data on the registry will be validated with source data and users will still engage with the source data and electronic health record as appropriate clinically and operationally.

An Electronic Registry to Improve Adherence to Active Surveillance Monitoring at a Safety-net Hospital

An Electronic Registry to Improve Adherence to Active Surveillance Monitoring Among Men With Prostate Cancer at a Safety-net Hospital: A Study Protocol

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Customized Registry Tool for Tracking Adherence to Clinical Guidelines for Head and Neck Cancers	NCT03546322	Head and Neck N...	Registry	18 Years -	University of California, San Francisco
Machine Learning to Predict Acute Care During Cancer Therapy	NCT05122247	Chemotherapeuti...	Machine learnin...	18 Years -	Duke University
Real-world Resource Use and Costs of CAR-T Therapies in Diffuse Large B-cell Lymphoma (DLBCL)	NCT05366257	Diffuse Large B...	CAR-T Allo-HSCT cohor...	18 Years - 85 Years	Novartis
Outpatient PDD Guided Laser Mediated Destruction of Bladder Tumors	NCT02886026	Bladder Cancer	Bladder tumor r... Diode laser (98...	18 Years -	University Hospital Bispebjerg and Frederiksberg
Customized Registry Tool for Tracking Adherence to Clinical Guidelines for Head and Neck Cancers	NCT03546322	Head and Neck N...	Registry	18 Years -	University of California, San Francisco
Customized Registry Tool for Tracking Adherence to Clinical Guidelines for Head and Neck Cancers	NCT03546322	Head and Neck N...	Registry	18 Years -	University of California, San Francisco
Patients Receiving Induction With Liposomal Daunorubicin and Cytarabine (CPX-351) for Acute Myeloid Leukemia	NCT03988205	Leukemia, Myelo...	Outpatient Care... CPX-351	18 Years -	Medical College of Wisconsin
Endoscopic Treatment of Inoperable Colorectal Cancer With the EndoVe System	NCT01172860	Colorectal Canc...	EndoVe endoscop...	18 Years -	Mercy University Hospital, Cork, Ireland
Outpatient Platelet Transfusions in Myelodysplastic Syndromes and Leukemia: The OPTIMAL Pilot	NCT01615146	Myelodysplastic... Leukemia	Platelet Transf...	18 Years -	Ottawa Hospital Research Institute
An Electronic Registry to Improve Adherence to Active Surveillance Monitoring at a Safety-net Hospital	NCT03553732	Prostatic Neopl...	Registry	18 Years -	University of California, San Francisco
Sentinel. Ambulatory. Oral Cavity. Oropharynx (S.A.C.O)	NCT03545256	Cancer T1-N0 or...	outpatient surg...	18 Years -	University Hospital, Montpellier

Spots Global Cancer Trial Database for outpatient

Every month we try and update this database with for outpatient cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for outpatient

Every month we try and update this database with for outpatient cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for outpatient cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.