RecruitingNCT04557969

Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis

Prospective Study of Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis


Sponsor

National Cancer Institute (NCI)

Enrollment

400 participants

Start Date

Dec 18, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

Objective: To follow people with GISTs and collect tumor tissue so that it can be studied in the lab. Eligibility: People age 6 and older who have a GIST. Design: Participants will be screened with a review of their medical records and samples. Participants will enroll in 1 other NIH study, and may be asked to enroll in 2 other optional NIH studies. Participants will have a medical history and physical exam. Data about how they function in their daily activities will be obtained. Participants may speak with a genetic counselor. They may have genetic testing. Participants will give blood samples. They may have a cheek swab. For this, small brush will be rubbed against the inside of the cheek. Participants may have a computed tomography (CT) scan of the chest, abdomen, and pelvis. Or they may have a CT scan of the chest and magnetic resonance imaging (MRI) of the abdomen and pelvis. Participants will be monitored every 6-12 months at the NIH Clinical Center, for up to 10 years before having surgery. If they need surgery, it will be performed at the NIH. Then, they will be monitored every 6-12 months, for up to 5 years after surgery. If a participant has surgery, tumor tissue samples and research specimen will be taken. If a participant does not need surgery, their participation will end after 10 years. If they have surgery, the 5-year monitoring period will restart after each surgery.


Eligibility

Min Age: 6 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates surgery and tissue analysis for gastrointestinal stromal tumors (GISTs) — a type of tumor found in the digestive tract. Researchers will use tumor samples to study how these tumors work and explore new ways to treat them. **You may be eligible if...** - You are 6 years of age or older - You have a confirmed or suspected GIST based on tissue analysis or clinical findings - You are in reasonably good health and able to tolerate surgery - You or your parent/guardian is able to understand and sign a consent form **You may NOT be eligible if...** - You have medical conditions that cannot be changed and that would prevent you from safely undergoing surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT04557969


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