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Search / Trial NCT04557969

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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Sep 18, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Tyrosine Kinase Inhibitor (Tki) Therapy Wild Type Gis Ts (Wt Gis Ts) Pdgfra Mutation Kit Mutation Sdh Mutation Natural History

ClinConnect Summary

This clinical trial is focused on studying gastrointestinal stromal tumors (GISTs), a type of cancer that can occur in the stomach and intestines. The main goal is to gather tissue samples from these tumors so that researchers can learn more about them in the lab. The trial is open to anyone aged 6 and older who has been diagnosed with a GIST. Participants will have their medical history reviewed, undergo physical exams, and may have genetic testing or imaging scans like CT or MRI to help assess their condition.

If you decide to join the trial, you'll be monitored at the NIH Clinical Center every 6 to 12 months for up to 10 years, and if surgery is needed, that will be performed at the NIH. After surgery, you'll continue to be monitored for up to 5 years. This study also allows you to take part in additional optional studies if you're interested. It's important to know that if you do not need surgery, your participation will end after the 10-year period. The goal of this trial is to improve our understanding of GISTs, which could lead to better treatments in the future.

Gender

ALL

Eligibility criteria

  • * INCLUSION CRITERIA:
  • Histological confirmation or clinical presentation suspicious of GIST; histological confirmation will be preferably by review of archival tissue if available, fresh biopsy will not be required if inadequate tissue sample.
  • Age \>= 6 years
  • ECOG performance status \<= 2 (Karnofsky or Lansky \>= 60%)
  • Ability of participant or parent/guardian to understand and the willingness to sign a written informed consent document.
  • EXCLUSION CRITERIA:
  • - Non-modifiable medical comorbidities that would preclude cytoreductive surgery.

About National Cancer Institute (Nci)

The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.

Locations

Bethesda, Maryland, United States

Patients applied

0 patients applied

Trial Officials

Andrew M Blakely, M.D.

Principal Investigator

National Cancer Institute (NCI)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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