Ireland
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Clinical Trials in Israel / NCT04871542
Recruiting Observational

Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors

NCT04871542 · tracked via the Priya Life Science Israel tracker
Phase
Observational
Started
2021-09-13
Last updated
2026-05-05

Condition(s) studied

Malignant Solid Neoplasm

Investigational drug(s) / intervention(s)

Biospecimen CollectionQuestionnaire Administration

Biospecimen Collection: Undergo collection of blood sample

Questionnaire Administration: Complete questionnaires

Study summary

This study examines how certain risk factors (such as age, gender, other medical conditions, and the type of immunotherapy used to treat the cancer) affect whether a patient with a malignant solid tumor will develop mild or serious side effects from the immunotherapy medications. Immunotherapy is the type of treatment that helps the body's immune system fight cancer. In the future, this information may help doctors make better decisions about cancer treatments.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Participants must be planning to receive ICI-based therapy for a solid tumor malignancy. This therapy must be given according to Food and Drug Administration (FDA) label or National Comprehensive Cancer Network (NCCN) guidelines at Category 1 or 2A and not in the context of a clinical trial * Participants who have received prior ICI-based therapy must have completed ICI based therapy at least 180 days prior to registration * Participants must not have discontinued any prior ICI-based therapy (if applicable) because of irAE * Participants must not have received chemotherapy, biologic, or targeted-therapy within 21 days prior to registration * Participants must have recovered from side effects of prior therapy to the following standards per treating physician's discretion: * =\< Grade 1 for any non-hematologic side effects (excluding neuropathy and alopecia); lab-related parameters of liver and renal function will be considered at the discretion of the treating physician) * =\< Grade 2 for neuropathy and/or alopecia * Grade 3 or less for any hematologic side effects * Participants must be planning to begin standard of care ICI-based therapy within 3 calendar days after registration * Participants must not be planning to receive ICI-based therapy in combination with chemotherapy or any other non-ICI therapy for treatment of their cancer * Participants must be at least 18 years of age * Participants must complete their history and physical examination within 28 days prior to registration * Participants who can complete the S2013 Feasibility Questionnaire in English or Spanish must participate at the scheduled assessments * Participants must be able to complete Patient-Reported Outcome (PRO) instruments in English, Spanish, or French and must be planning to complete PROs at all scheduled assessments * Participants must complete the pre-registration (baseline) PRO forms within 14 days prior to registration * Participants must be willing to participate in PRO data collection * Note: Prior to registration, participants must decide on their method (paper or electronic) of completing their follow-up questionnaires. Participants who elect electronic (ePRO) completion must have an iPhone, Android phone, or tablet with cellular or WiFi connectivity in order to download the Patient Cloud mobile applications onto the device (personal device or a site provisioned device for multi-users) * Participants must be offered the opportunity to participate in the optional specimen banking * Note: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system. * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines

Primary outcome measure(s)

Trial sites (849)

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 Recruiting
Banner University Medical Center - Tucson Tucson Arizona Suspended
University of Arizona Cancer Center-North Campus Tucson Arizona Suspended
Onvida Health Yuma Medical Center Yuma Arizona Suspended
Mercy Hospital Fort Smith Fort Smith Arkansas Recruiting
CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas Suspended
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas Recruiting
CARTI Cancer Center Little Rock Arkansas Recruiting
Kaiser Permanente-Deer Valley Medical Center Antioch California Recruiting
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California Recruiting
PCR Oncology Arroyo Grande California Recruiting
Keck Medicine of USC Buena Park Buena Park California Suspended
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California Recruiting
Marshall Cancer Center Cameron Park California Suspended
Mercy Cancer Center - Carmichael Carmichael California Recruiting
Mercy San Juan Medical Center Carmichael California Recruiting
Kaiser Permanente Dublin Dublin California Recruiting
Mercy Cancer Center - Elk Grove Elk Grove California Recruiting
Kaiser Permanente-Fremont Fremont California Recruiting
VA Central California Fresno Medical Center Fresno California Recruiting
Fresno Cancer Center Fresno California Recruiting
Kaiser Permanente Fresno Orchard Plaza Fresno California Recruiting
Kaiser Permanente-Fresno Fresno California Recruiting
Keck Medicine of USC Huntington Beach Huntington Beach California Suspended
Tibor Rubin VA Medical Center Long Beach California Suspended
Keck Medicine of USC Koreatown Los Angeles California Suspended
Los Angeles General Medical Center Los Angeles California Suspended
USC / Norris Comprehensive Cancer Center Los Angeles California Active Not Recruiting
Contra Costa Regional Medical Center Martinez California Recruiting
Fremont - Rideout Cancer Center Marysville California Suspended

+ 809 more sites — see the full list on the official registry below.

More SWOG Cancer Research Network 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 NCT04871542 on ClinicalTrials.gov ↗ ← All trials in Israel