Collecting tumor tissue from patients with gastrointestinal stromal tumors for research
Prospective Study of Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis
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 |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT04557969 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 6 and older with a confirmed diagnosis of gastrointestinal stromal tumors.
Not a fit: Patients with non-modifiable medical comorbidities that would prevent them from undergoing necessary surgical procedures may not benefit from this study.
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 performed: Other studies have shown success in utilizing tumor tissue for genomic analysis and drug research, making this approach promising yet still requiring further exploration.
Eligibility criteria
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 this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.