Collecting tumor tissue from patients with gastrointestinal stromal tumors for research
Official title: Prospective Study of Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis
Run by National Institutes of Health Clinical Center (CC) · NCT04557969 · Data updated 2026-11-12
This study is collecting tumor samples from people with gastrointestinal stromal tumors to help researchers learn more about the disease and how to treat it better.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 6 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | December 18, 2020 |
| Main results expected | December 30, 2040 |
| Study ends | December 30, 2040 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT04557969 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals aged 6 and older with a confirmed diagnosis of gastrointestinal stromal tumors.
✕Probably not a fit
Patients with non-modifiable medical comorbidities that would prevent them from undergoing necessary surgical procedures may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to follow individuals diagnosed with gastrointestinal stromal tumors (GISTs) and collect tumor tissue samples for laboratory analysis. Participants aged 6 and older will undergo medical history reviews, physical exams, and may have genetic counseling and testing. The study will also involve blood samples, cheek swabs, and imaging studies like CT and MRI scans. Participants will be monitored at the NIH Clinical Center for up to 10 years to assess disease progression and support translational research.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients with GISTs, particularly those with wild-type and treatment-resistant tumors.
How similar studies have gone: Other studies have shown success in utilizing tumor tissue for genomic analysis and drug research, making this approach promising yet still requiring further exploration.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
National Institutes of Health Clinical Center
Bethesda, Maryland, United States Recruiting
Study contacts
- Principal investigator: Andrew M Blakely, M.D. — National Cancer Institute (NCI)
- Study coordinator: Stephanie N Canady, R.N.
- Email: stephanie.canady@nih.gov
- Phone: (240) 858-7573
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.