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Clinical Trials in Israel / NCT04242095
Recruiting Observational

Collection of Research Data and Samples From Patients Treated With Immunotherapy to Study Its Side Effects

NCT04242095 · tracked via the Priya Life Science Israel tracker
Phase
Observational
Started
2020-03-12
Last updated
2026-09-17

Condition(s) studied

Hematopoietic and Lymphoid Cell NeoplasmImmune System DisorderMalignant Solid Neoplasm

Investigational drug(s) / intervention(s)

Biospecimen CollectionMedical Chart Review

Biospecimen Collection: Undergo collection of tissue, blood, and stool samples

Medical Chart Review: Review of medical records

Study summary

This study collects research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. Studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
* PRE-REGISTRATION ELIGIBILITY CRITERIA: Planning to receive a regimen containing one or more IO therapeutics * PRE-REGISTRATION ELIGIBILITY CRITERIA: Has not previously been treated with CTLA-4, PD-1 or PD-L1 inhibitors * PRE-REGISTRATION ELIGIBILITY CRITERIA: Willing and able to provide baseline blood and stool samples * REGISTRATION ELIGIBILITY CRITERIA: Received a regimen containing one or more immuno-oncology therapeutics * Must have received one or more IO therapeutics * In addition to one or more IO therapeutics, patients may also have received other therapeutics such as chemotherapy, hormonal or targeted therapy, as long as these are reported * REGISTRATION ELIGIBILITY CRITERIA: Must have experienced one or more of the following: * One or more serious (grade 3-54) AEs that are likely immune-related. AEs included in Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0 that may be immune-related \*\* Patients who experience only hematologic cytopenia(s) who have received cytotoxic therapies, e.g., chemotherapy, within 60 days prior to registration should be excluded * One or more grade 2 dermatologic, endocrine (except diabetes/hyperglycemia) or rheumatologic AEs that are likely immune-related. AEs included in CTCAE v. 5.0 that may be immune-related * Diagnosis of a rare infection, e.g., fungal or mycobacterial, after starting IO treatment \*\* Note: Diagnosis of SARS-CoV-2 (COVID-19) is excluded * Hyperprogression. Image submission for patients experiencing hyperprogression is required. For assistance in determining hyperprogression for purposes of eligibility, institutions may contact the study chair and submit images for central review * REGISTRATION ELIGIBILITY CRITERIA: Has not previously been registered to this study \* The same patient cannot be enrolled more than once to this study due to development of subsequent irAEs

Primary outcome measure(s)

Trial sites (625)

FacilityCityRegionStatus
Anchorage Associates in Radiation Medicine Anchorage Alaska Recruiting
Anchorage Radiation Therapy Center Anchorage Alaska Suspended
Alaska Breast Care and Surgery LLC Anchorage Alaska Recruiting
Alaska Oncology and Hematology LLC Anchorage Alaska Recruiting
Alaska Women's Cancer Care Anchorage Alaska Recruiting
Anchorage Oncology Centre Anchorage Alaska Suspended
Katmai Oncology Group Anchorage Alaska Recruiting
Providence Alaska Medical Center Anchorage Alaska Recruiting
Fairbanks Memorial Hospital Fairbanks Alaska Suspended
Kingman Regional Medical Center Kingman Arizona Recruiting
Cancer Center at Saint Joseph's Phoenix Arizona Active Not Recruiting
Mayo Clinic Hospital in Arizona Phoenix Arizona Recruiting
Mercy Hospital Fort Smith Fort Smith Arkansas Recruiting
CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas Suspended
CARTI Cancer Center Little Rock Arkansas Recruiting
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California Active Not Recruiting
PCR Oncology Arroyo Grande California Recruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California Recruiting
Mercy Cancer Center - Carmichael Carmichael California Active Not Recruiting
Mercy San Juan Medical Center Carmichael California Active Not Recruiting
Epic Care-Dublin Dublin California Active Not Recruiting
Mercy Cancer Center - Elk Grove Elk Grove California Active Not Recruiting
Bay Area Breast Surgeons Inc Emeryville California Active Not Recruiting
Epic Care Partners in Cancer Care Emeryville California Active Not Recruiting
Washington Health Fremont California Recruiting
Veterans Affairs Loma Linda Healthcare System Loma Linda California Recruiting
Contra Costa Regional Medical Center Martinez California Active Not Recruiting
Mercy Cancer Center Merced California Active Not Recruiting
Bay Area Tumor Institute Oakland California Active Not Recruiting
Mercy Cancer Center - Rocklin Rocklin California Active Not Recruiting
Mercy Cancer Center - Sacramento Sacramento California Active Not Recruiting
Zuckerberg San Francisco General Hospital San Francisco California Recruiting
Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California Active Not Recruiting
Mission Hope Medical Oncology - Santa Maria Santa Maria California Active Not Recruiting
Saint Helena Hospital St. Helena California Recruiting
Saint Joseph's Medical Center Stockton California Active Not Recruiting
Epic Care Cyberknife Center Walnut Creek California Active Not Recruiting
BASS Medical Group - Lennon Walnut Creek California Active Not Recruiting
Woodland Memorial Hospital Woodland California Active Not Recruiting
Rocky Mountain Cancer Centers-Aurora Aurora Colorado Active Not Recruiting

+ 585 more sites — see the full list on the official registry below.

More Alliance for Clinical Trials in Oncology trials in Israel

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04242095 on ClinicalTrials.gov ↗ ← All trials in Israel