Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Gland and Hormone Related Diseases

Rare Diseases

Death

Melanoma

Prostatic Neoplasms

Stomach Neoplasms

Glioblastoma

Head and Neck Neoplasms

Carcinoma, Renal Cell

Lung Neoplasms

Liver Neoplasms

Testicular Neoplasms

Kidney Neoplasms

Rectal Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neoplasms, Glandular and Epithelial

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Rectal Diseases

Endocrine Gland Neoplasms

Endocrine System Diseases

Testicular Diseases

Gonadal Disorders

Renal Cell Carcinoma

Stomach Cancer

Neuroepithelioma

All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.

All participants randomized to Arm B will receive usual oncologic care.

Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.

EPAC

The Engagement of Patients with Advanced Cancer is an intervention that utilizes well-trained lay health coaches to engage patients and their families in goals of care and shared decision-making after a diagnosis of advanced cancer. Although lay health workers have never been tested in this role, we hypothesize that lay health workers can feasibly improve goals of care documentation and help to reduce unwanted healthcare utilization at the end of life for Veterans diagnosed with new advanced stages of cancer and those diagnosed with recurrent disease.

VAPAHCS proposes to implement and evaluate several critical elements to be in alignment with the VHA's Strategic Goal and priority areas for FY2013. The Engagement of Patients with Advanced Cancer project is an innovative program that will strengthen provider-patient relationship and facilitate whole person care about matters important to Veterans with cancer and important to support network and family. The project is intended to help establish Goals of Care Plan with appropriate documentation, develop, deploy, and evaluate a model of care for persons with cancer that is intended to improve clinical outcomes and experience of care for individuals with advanced cancer who have advanced cancer (stages III, IV or recurrent disease). The intervention provides patients with lay health coaches who assist patients and their families in discussing goals of care and engage in shared-decision making. The goal of the project is to demonstrate that there is improved patient experiences, outcomes, and that the program helps to reduce utilization of health care resources at the end of life.

Engagement of Patients With Advanced Cancer

Feasibility is defined as at least 75% of patients in the intervention arm with a documented Goals of Care titled medical note within 6 months of patient enrollment in the study.

Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.

Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.

Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.

Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.

Hospice referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.

Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.

Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.

Each patient will receive a satisfaction with care survey (The Consumer Assessment of Health Care Providers and Systems - General (CAHPS)) at baseline and 6 months. We will measure the change in satisfaction from baseline to 6 months. Scores for satisfaction were assessed using the Consumer Assessment of Healthcare Providers and Systems-General survey question #18 which measured rating of health provider, on which scores range from 0 to 10, with higher ratings correspond to higher patient satisfaction. Scores for each group are averaged at baseline and at 6 months.

Each patient will receive a validated satisfaction with decision-making survey (The Satisfaction with Decision Survey) at 6 months after study enrollment.Satisfaction with Decision was assessed with the use of the 6-question Satisfaction with Decision Scale, on which scores range from 0 to 5, with higher scores indicating better satisfaction with decision-making. Scores for each group are averaged at 6 months after study enrollment.

VA Palo Alto Health Care System

Stanford University

Assistant Professor

All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.

EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.

A: Intervention Arm

B: Control Group Arm

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Cancer Diagnosis

Cancer Stage at Diagnosis

Marital Status

Total Baseline Health Care Costs

Dr. Manali Patel

Number of Participants With Completed Goals of Care Documentation. We Will Evaluate if 75% of Patients in the Intervention Arm Have a Documented Goals of Care Titled Medical Note Within 6 Months of Patient Enrollment in the Study.

Emergency Department Visit (Chart Review)

Hospitalization Visits (Chart Review)

Hospice Referral (Chart Review)

Palliative Care Referral (Chart Review)

Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey

Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey

Baseline Satisfaction Survey

6 Month Satisfaction Decision Survey

6 Month Satisfaction Survey

6-Month Utilization and Cost

15-Month Utilization and Cost

End of Life Utilization and Cost 6 Month

End of Life Utilization and Cost 15month

Blood and Lymph Conditions

Esophageal Neoplasms

Skin Neoplasms

Hematologic Neoplasms

Breast Neoplasms

Urinary Bladder Neoplasms

Uterine Neoplasms

Hematologic Diseases

Breast Diseases

Skin Diseases

Esophageal Diseases

Stomach Diseases

Urinary Bladder Diseases

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases, Female

Esophageal Cancer

Genomic profiling, indicated as assessed by the medical need and as deemed appropriate by the physician according to routine practice

Genomic testing

Richard Greil, MD

Thomas Winder, MD

Armin Gerger, MD

Andreas Seeber, MD

Martin Pecherstorfer, MD

Andreas Petzer, MD

Petra Pichler, MD

Klaus Wilthoner, MD

Sonja Heibl, MD

Christian Singer, MD

Edward Wöll, MD

There is no evidence available about which molecular profiling methods are currently used for cancer patients in Austrian clinical practice. The construction of the registry proposed as a completely independent research endeavor, will be helpful for scientific evaluation and the establishment of highly credible data.

In the situation of enormous possible beneficial options for patients, health care systems, researchers and companies and the simultaneously present high number of uncertainties, the establishment of an independent registry for patients undergoing any type of comprehensive genomic profiling offers many advantages.

In particular, an overview of the speed of development, the "market penetration", the use of the technology in specific indications (tumor types, stages and in specific situations of unresponsiveness to certain drugs), the frequency by which treatment decisions will definitely follow the result of comprehensive genomic profiling and the reasons for this, the treatment outcome of such patients, the platform technologies applied (in-house (which types), vs. commercial) and the development of these parameters over time and in relation to the development of novel drugs will be analyzed.

The registry proposes to cover the time period from the years 2016 to 2019, which will allow for assessment of both the current and emerging landscape of genomic/molecular testing practice in Austria and effect of molecular profiling on patient care and outcome.

Genomic Testing and Resulting Medical Decisions

The Use of Genomic Testing and the Resulting Medical Decisions According to Target Identification

To describe types of:molecular profiling methods used in the Austrian registry centres

To describe types of cancer, for which comprehensive molecular profiling is used

To describe the timing of molecular profiling in relation to stage of the disease (e.g. at diagnosis, after surgery, radiation therapy, after first/second/third/late line)

To describe targets identified:

* number of patients with at least one mutation identified
* number of patients with at least one druggable target identified
* number of patients with more than one druggable targets identified
* number of druggable targets per cancer type

To describe tests used and quality standards:

* to compare results of NGS based molecular test systems with single marker tests or small gene panel tests
* quality standards of the test methods used (TAT, certification status)
* to evaluate development of methods used over time
* usage of commercial testing vs. in-house testing, platforms used, and number of genes as well as gene size analyzed (eg whole exome with or without selected intron sequencing vs. hot spot exome sequencing)

To describe treatment decisions:

* frequency by which treatment decision follows the result of NGS testing
* frequency with druggable targets with available on-label therapy option
* treatment decisions in the presence of more than one druggable target

To describe outcome of treatment in patients receiving therapy in concordance with the test result

Roche Pharma AG

AstraZeneca

Arbeitsgemeinschaft medikamentoese Tumortherapie

Carcinoma

Neoplasms, Unknown Primary

Neoplasm Metastasis

Neoplastic Processes

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Mebendazole

Anthelmintics

Antiparasitic Agents

Tubulin Modulators

Antimitotic Agents

ReposMBZ 100 mg capsule by mouth followed by 8h PK sampling to decide the initial daily dose.

Treatment: Repos MBZ capsules by mouth twice daily for 16 weeks, daily dose 50mg-4g, based on the serum level of mebendazole.

ReposMBZ

This study will evaluate the safety and efficacy of mebendazole (ReposMBZ) in patient with advanced gastrointestinal cancer or cancer of unknown origin. All patients will be given ReposMBZ for 16 weeks continuous treatment, individually dosed based on the serum concentration of mebendazole.

Mebendazole has been used extensively during long time for local gut helminthic infections at low dose but also at considerably higher doses during months to years against invasive echinococcus infections. Recent research has now clearly indicated that mebendazole has anticancer effect. Given these observations and the experience of excellent tolerance to mebendazole the current clinical trial protocol is based on the repositioning strategy to more extensively investigate whether mebendazole could be developed into a useful anticancer drug.

A Clinical Safety and Efficacy Study of Mebendazole on GI Cancer or Cancer of Unknown Origin.

A Phase 2a TDM-guided Clinical Study on the Safety and Efficacy of Mebendazole in Patients With Advanced Gastrointestinal Cancer or Cancer of Unknown Origin

Genetic changes and infiltration of immune cells, grade, molecular subtype, gene and protein expression and tumour infiltration and subtypes of macrophages and lymphocytes.

Changes in the properties analysed in the archived tissue (baseline) and the fresh biopsy.

Mean S-mebendazole concentration during treatment phase in relation to safety (CTCAE 4.03 grade 3 and 4 toxicity) and efficacy (tumour response and TTP) respectively.

Blood chemistry (plasma): Sodium, Potassium, Calcium, Glucose (mmol/L)

Blood chemistry (plasma): Bilirubin (µmol/L)

Blood chemistry (plasma): ALAT, ASAT, LDH, ALP (µkat/L)

Haematology: RBC (red blood cell count), White blood cells with differential count and platelets (absolute count/L)

Coagulation (plasma): Prothrombin complex (INR)

Systolic and diastolic blood pressure (mmHg) Weight (kg)

Best overall radiological response Time to tumour progression (TTP) compared with TTP on the treatment just preceding this protocol.

Cmax will be used to decide the starting dose in the treatment phase.

Analysis of serum concentration after single dose administration of ReposMBZ.

Cmax will be used to adjust the dose until target S-mebendazole level is reached and to show the individual variation of S-mebendazole concentration over time

Number of patients that reach the steady state S-mebendazole target concentration.

Time from first dose in treatment phase until target S-mebendazole concentration is reached

Change of cytokine levels in blood, evaluated by cytokine array.

Up-regulation of activation markers compared to baseline, evaluated by flow cytometry.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Engagement of Patients With Advanced Cancer	NCT02966509	End of Life Advanced Cancer Lung Neoplasm Gastric Cancer Colon Cancer Glioblastoma Mu... Head and Neck N... Rectum Cancer Melanoma Kidney Cancer Prostate Cancer Testicular Neop... Liver Cancer Cancer of Unkno...	EPAC	18 Years -	Stanford University
Genomic Testing and Resulting Medical Decisions	NCT03301493	Cancer of Unkno... Cancer Refracto... Cancer of Stoma... Cancer Head Nec... Cancer of Skin Cancer, Lung Cancer Colorect... Cancer of Esoph... Cancer, Bladder Cancer, Uterus Cancer Cervix Cancer Liver Cancer, Kidney Cancer, Breast Hematologic Neo...	Genomic testing	18 Years -	Arbeitsgemeinschaft medikamentoese Tumortherapie
A Clinical Safety and Efficacy Study of Mebendazole on GI Cancer or Cancer of Unknown Origin.	NCT03628079	Cancer of the G... Cancer of Unkno...	ReposMBZ	18 Years -	Repos Pharma

Spots Global Cancer Trial Database for cancer of unknown origin