Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Neoplastic Processes

Data collection for patient medical charts and patient fill out questionnaires first visit and post-treatment visits

Only radiation oncology patients data from medical records regarding treatment, demographics and follow-up visits will be collected and logged by investigators.

Data collection and analysis

Participants will be asked to complete a set of short forms at first visit and post-treatment visits. If participant has a routine visit about 3 months after treatment, participant will be asked to complete a final form that is optional.

Quality of Life Questionnaire

Doris Brown, MD, PhD

The proposed study represents a quality improvement study of a recently-developed dedicated radiation oncology subspecialty clinic with the goal of improving timeliness of palliative radiation therapy and improving resident training in palliative care topics. The aim of this study is to evaluate the impact of this clinic on time to palliative radiation therapy following referral.

Primary Objective:

• Determine whether interval between palliative radiation therapy referral and palliative radiation therapy initiation is shorter for participants treated in a dedicated palliative radiation oncology clinic compared to the same interval for participants treated in a general radiation oncology clinic (historical control). The investigators' hypothesis is that this interval will be significantly shorter among the Palliative Radiation Oncology Chief's Clinic participants compared to historical control.

Secondary Objectives:

* Determine whether each of the three component intervals within the overall interval from referral to treatment initiation (i.e., referral to consultation; consultation to simulation; simulation to treatment) is shorter for participants treated in a dedicated palliative radiation oncology clinic compared to the length of the same intervals for participants treated in a general radiation oncology clinic (historical control). The investigators' hypothesis is that each of these component intervals will be significantly shorter among the Palliative Radiation Oncology Chief's Clinic participants compared to historical control.
* Describe levels of and changes over time in patient-reported quality of life after palliative radiation therapy in the full sample, and in subgroups stratified by various radiation regimens. The investigators' hypothesis is that participants who receive a shorter course of palliative radiation (one day or five days) will have greater improvements in overall quality of life than participants who receive a ten-day course of palliative radiation.
* Determine median overall survival after palliative radiation therapy.

Palliative Radiation Oncology Chief's Clinic

Palliative Radiation Oncology Chief's Clinic (PROCC): Assessing the Impact of a Dedicated Clinic on the Timeliness of Palliative Radiotherapy

Number of days between referral to palliative radiation therapy interval and start of palliative radiation therapy compared to historical control. Mean time from referral to the start of RT (measured in days) will be computed for our sample and compared to the historical control mean of 13.4 days using a two-sided one-sample t-test.

Mean time from referral to consultation will be computed for our sample and compared to the historical control mean of 3.6 days.

Mean time from consultation to CT simulation will be computed for our sample and compared to the historical control mean of 3.8 days.

Mean time from CT simulation to start of PRT will be computed for our sample and compared to the historical control mean of 6.1 days.

Levels of and changes in patient-reported overall quality of life as measured by the EORTC QLQ-C15-PAL (14 questions) at baseline and at 1-month and 3-month intervals after end of palliative radiation therapy. Quality of life score scale consists of 1 = not at all to 4 = very much. The higher the QOL score the greater change in the participant's quality of life.

Median overall survival (number of days between start of radiation therapy and death from any cause) will be estimated using the Kaplan-Meier method and compared (with a one-sample logrank test and assuming a Weibull distribution parameter of 1.0) to the median overall survival of n=134 days in our historical control.

Wake Forest University Health Sciences

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Communicable Diseases

Prostatic Neoplasms

COVID-19

Carcinoma, Renal Cell

Kidney Calculi

Nephrolithiasis

Calculi

Urinary Bladder Neoplasms

Urinary Tract Infections

Urogenital Diseases

Kidney Neoplasms

Urogenital Neoplasms

Pneumonia

Pneumonia, Viral

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

Respiratory Tract Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Renal Cell Carcinoma

GU patients from medical records with active or past infection of SARS-Co-V-2

Monali Fatterpekar, PhD

Cristina Pasat-karasik, RN

Ashutosh K Tewari, MD

Dimple Chakravarty, PhD

Sujit S Nair, PhD

The purpose of this research study is to identify patients with GU disease with active or past COVID-19 infection.

Participants will be asked to:

* Complete an Online COVID-19 Questionnaire.
* Disclose if the patient has or had Genitourinary cancer or benign urologic condition
* Provide urine specimen for research
* Provide 4 tablespoons of blood for testing blood for research.
* Provide permission to access medical records, such as patient lab results, medical history, imaging reports, etc.

COVID-19 has a higher incidence in males compared to females and cancer patients have a higher risk of contracting COVID-19, and developing complications, and deteriorate more rapidly. COVID19 pandemic poses significant challenges in clinical decision-making, which has impacted management of GU patients. In order to mitigate the risk associated with COVID19 pandemic while also providing the best clinical care for patients a screening approach is essential. Clinicians taking care of cancer patients will be expected not only to understand impact of COVID19 but also incorporate a triage tool to decide which patients need immediate treatment. This prospective study presented in this IRB is about establishing a screening tool for GU patients with pre-existing cancer or with benign urological disease (e.g. BPH, kidney stone, bladder infection, urinary tract infections etc) and for those who are dealing with decisions for biopsy, active surveillance, surgery, radiation, hormonal and chemotherapy.

The study team is expecting to enroll 15240 subjects under this study.

Procedures involved in the study:

1. Consenting patients for the study.
2. Screening/Baseline REDCap survey to determine their COVID-19 symptoms.
3. Blood sample collection: This will be obtained for research studies including immune monitoring assays
4. Urine sample collection for bio-marker analysis.
5. Data collection from medical records, such as:

   * Clinical diagnoses, including date of confirmation of SARS-CoV-2 infection
   * Any pertinent medical history, including concomitant medications, and comorbidities that pre- date enrollment in the study, or that occur during enrollment in the study
   * Laboratory values from time of blood procurement
   * All imaging (X-ray, MRI, CAT, PAT, PSMA, Ultrasound, and Pathology etc.) performed from time of initial diagnosis until death, and any needed imaging that pre- date enrollment that may serve as a comparative to pre/post treatment imaging.
   * Collection time of samples in relation to study treatment
   * Demographic data
   * REDCap questionnaire, COVID-19 symptoms and severity of the symptoms

1. Peripheral blood - plasma and serum for PBMCs and aliquots.
2. Urine

Impact of COVID-19 on GU Disease

Mitigating Risk of COVID-19 for Clinical Management of Genitourinary Diseases

All of the individual participant data collected during the trial, after deidentification.

Proportion of patients with a new diagnosis of GU cancer and with active or past infection with SARS-Co-V-2

Proportion of GU cancer patients, with active disease or in remission and with active or past infection with SARS-Co-V-2

Proportion of patients with the benign urologic condition and with active or past infection with SARS-Co-V-2

Icahn School of Medicine at Mount Sinai

Professor and System Chair, Urology

Blood and Lymph Conditions

Syndrome

Leukemia

Hematologic Neoplasms

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Hematologic Diseases

Bone Marrow Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Lipid Regulating Agents

All Drugs and Chemicals

Atorvastatin

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Enzyme Inhibitors

Atorvastatin 80 milligrams (mg) per day, orally for 1 - 4 weeks before surgery (surgery not part of clinical trial)

Joaquina Baranda, MD

This is a window-of-opportunity trial to determine if atorvastatin given for 1 to 4 weeks at a dose of 80 milligrams per day (mg/day) is sufficient to decrease the level of conformational mutant tumor protein 53 (p53) in malignant diseases (solid tumor and relapsed Acute Myeloid Leukemia (AML)).

A Pilot Trial of Atorvastatin in Tumor Protein 53 (p53) -Mutant and p53 Wild-Type Malignancies

A Pilot Trial of Atorvastatin in p53-Mutant and p53 Wild-Type Malignancies

Measured by immunohistochemistry (IHC) staining. Reported as overall percent difference in the level of conformation mutant p53.

Measured by immunohistochemistry (IHC) staining. Reported as overall percent difference in the level of Ki-67 (also known as MKI67) in the conformation mutant p53 samples.

Measured by immunohistochemistry (IHC) staining. Reported as overall percent difference in the level of caspase-3 in the conformation mutant p53 samples.

Joaquina Baranda

Associate Professor University of Kansas Cancer Center - Medical Oncology

Skin and Connective Tissue Diseases

Immune System Diseases

Breast Neoplasms

Lymphedema

Lymphoma

Lymphatic Diseases

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Lymphosarcoma

Spa treatment linked with education therapeutic during 18 days just after randomization : common to all of spa resorts

Spa treatment linked with education therapeutic during 18 days 6 months visit after randomization

Spa treatment linked education therapeutic in lymphoedema post breast cancer (whirlpool bath with automatic air and water massage cycles, massaging shower/individuals and groups educational sessions)

Immediate spa treatment

Late spa treatment

Alexa COMTE

Carole ROLLAND

Michèle VIONNET FUASSET, MD

Simon SOUDET

Michèle FONTAINE

Sylvie BADENCO

Catherine GROSSETETE, MD

Fany GAYRAUD

Julie MALLOIZEL DELAUNAY

Louis DOUBLET

Anne TISSOT, MD

Patrick CARPENTIER, MD

THERMOEDEME is a comparative, controlled, randomized, multicenter and simple blinded (investigator) trial.

The aim of this study is to evaluate effects of spa therapy in phlebology with a therapeutic education program in daily life of patients suffering lymphoedema.

Lymphoedema is a chronic disease related to an insufficiency of the lymphatic system, which most often affects the limbs. Secondary forms are the most common, particularly those following surgical and radiotherapy treatments for cancer, the most classic being the post-therapeutic large arm of breast cancer.

The lymphoedema is a traditional phlebology indication in spa therapy. The spa therapy linked with therapeutic education could constitute a favorable environment for the treatment of lymphoedema.

The primary endpoint is the comparison of the rate of patients improved from baseline to 6 months on LMS27 (upper limb lymphoedema) or LYMQOL-LEG (lower limb lymphoedema) (Improvement is defined as 7 points between baseline and 6-month follow-up).

2 groups:

* Immediate spa therapy: the patient carries out the spa therapy with education therapeutic soon after the enrolment in the study
* Late spa therapy: the patient carries out the spa therapy with education therapeutic after the 6-month follow up

The investigator doesn't know the group of randomization of the patient. The spa therapy organisation is managed by the coordination center.

Spa Therapy for Upper or Lower Limb Lymphoedema

Spa Therapy for Upper or Lower Limb Lymphoedema : a Randomized and Comparative Study

Rate of patients with an improvement of 7 points minimum of the LMS27 scale (specific quality of life scale in upper limb lymphoedema) at 6 months.

The LMS27 scale is composed of 27 questions with 5 answers possible : never, rarely, sometimes, often, always. The answer's score is respectively 1 (worse outcome) to 5 (better outcome). The higher the score is, the better the lymphoedema quality of life is.

Rate of patients with an improvement of 7 points minimum of the LYMQOL-LEG scale (specific quality of life scale in lower limb lymphoedema) at 6 months.

The LYMQOL-LEG scale is composed of 26 questions with 4 answers possible: not at all, a little, quite a bit, a lot.

In order to to standardize with the LMS27 scale (for upper limb lymphoedema), the quotations are reversed: the answer's score is respectively 1 (worse outcome) to 4 (better outcome). The higher the score is, the better the lymphoedema quality of life is.

Evolution of the LMS27 scale (specific quality of life scale in upper limb lymphoedema) at 6 and 12 months.

The LMS27 scale is composed of 27 questions with 5 answers possible : never, rarely, sometimes, often, always. The answer's score is respectively 1 (worse outcome) to 5 (better outcome). The higher the score is, the better the lymphoedema quality of life is.

Evolution of the LYMQOL-LEG scale (specific quality of life scale in lower limb lymphoedema) at 6 and 12 months.

The LYMQOL-LEG scale is composed of 26 questions with 4 answers possible: not at all, a little, quite a bit, a lot.

In order to to standardize with the LMS27 scale (for upper limb lymphoedema), the quotations are reversed: the answer's score is respectively 1 (worse outcome) to 4 (better outcome). The higher the score is, the better the lymphoedema quality of life is.

Evolution of 5 items the most embarrassing chosen by the patients in the LMS27 scale (specific quality of life scale in upper limb lymphoedema) at 6 and 12 months.

The LMS27 scale is composed of 27 questions with 5 answers possible : never, rarely, sometimes, often, always. The answer's score is respectively 1 (worse outcome) to 5 (better outcome). The higher the score is, the better the lymphoedema quality of life is.

Evolution of 5 items the most embarrassing chosen by the patients in the LYMQOL-LEG scale (specific quality of life scale in lower limb lymphoedema) at 6 and 12 months.

The LYMQOL-LEG scale is composed of 26 questions with 4 answers possible: not at all, a little, quite a bit, a lot.

In order to to standardize with the LMS27 scale (for upper limb lymphoedema), we decide to reverse the quotations: the answer's score is respectively 1 (worse outcome) to 4 (better outcome). The higher the score is, the better the lymphoedema quality of life is.

Improvement of generic quality of life (the Euroquol EQ5D-3L scale) at 6 and 12 months.

EQ5D-3L is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of lige that can be used in a wide range of health conditions and treatments. The EQ5D-3L has 6 items intended to measure general health. The top 5 rate mobility, independence, daily activities, pain / discomfort, and anxiety / depression, and are rated according to 3 values from "No problem" to "Problem" or "Incapacity". This results in an index score. The last item deals with perceived health on the day the questionnaire is filled in and uses a visual analogue scale from 0 (wors) to 100 (best health possible) (Visual Analog Scale Score)

Evolution of the volume of the upper or lower extremity evaluated (overall and then by segment) from staged perimeter measurements at 6 and 12 months.

Evaluation of the costs incurred by lymphoedema (hospitalisations, medical and paramedical acts, treatments).

Evaluation of the spa therapy compliance : number of health care performed in spa therapy.

Verification of the achievement of educational targets in spa therapy by phone follow up.

Evaluation of all adverse events related to treatment, or not, according to the usual criteria of pharmacovigilance in clinical trials.

Monthly measurements of functional discomfort from inclusion to 12 months; The functional discomfort is measured monthly by a visual scale : not discomfort to maximal discomfort.

Evaluation of the maintenance of benefits at 12 months (stability of the long term effect) on the primary outcome and secondary outcomes.

Confirmation of the extent of the effect between 6 and 12 months on the primary outcome and secondary outcomes.

Sub group analysis on the primary outcome measure (stratification on primo spa therapy, lymphoedema severity and lymphoedema localization)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Palliative Radiation Oncology Chief's Clinic	NCT03995927	Malignant Disea... Metastasis	Data collection... Quality of Life...	18 Years -	Wake Forest University Health Sciences
Impact of COVID-19 on GU Disease	NCT04761107	COVID-19 Infect... Genitourinary C... Benign Urologic...		40 Years -	Icahn School of Medicine at Mount Sinai
A Pilot Trial of Atorvastatin in Tumor Protein 53 (p53) -Mutant and p53 Wild-Type Malignancies	NCT03560882	Malignant Disea... Solid Tumor Acute Myeloid L... Myelodysplastic... Cancer Relapsed Hemato...	Atorvastatin	18 Years -	University of Kansas Medical Center
Spa Therapy for Upper or Lower Limb Lymphoedema	NCT03580109	Lymphoedema Breast Cancer Malignant Disea... Gynaecological ... Lymphoma Prostate Cancer	Immediate spa t... Late spa treatm...	18 Years -	Association Francaise pour la Recherche Thermale
CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant	NCT02061800	Chronic Myeloid... Acute Myelogeno... Myelodysplastic... Juvenile Myelom... Acute Lymphobla... Lymphoma (Hodgk...	CliniMACS CD34+... Thiotepa Cyclophosphamid... Alemtuzumab Tacrolimus Melphalan Busulfan Fludarabine Methylprednisol...	- 22 Years	Columbia University

Spots Global Cancer Trial Database for malignant disease