Actively Recruiting
Prospective Study of Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis
Led by National Cancer Institute (NCI) · Updated on 2026-06-05
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate and follow people with gastrointestinal stromal tumors (GISTs), focusing on those with wild-type (WT) and treatment-resistant types. GISTs are rare soft tissue sarcomas often characterized by specific genetic mutations. Since many GISTs may become resistant to current drug therapies, surgical removal remains the main treatment, and this study supports research to better understand and develop new treatment options for these tumors. Participants with confirmed or suspected GIST will be monitored closely over long periods. Those suitable will be offered surgery to remove tumors, while others will be under active surveillance. The study includes up to 10 years of monitoring before surgery and up to 5 years after surgery, with the possibility of multiple surgeries and renewed monitoring periods. Tumor tissue samples will be collected during surgery to support laboratory research and genomic analysis. Participants will have regular medical history reviews, physical exams, and evaluations of daily functioning. They may undergo genetic counseling and testing, blood draws, cheek swabs, and imaging scans like CT or MRI. Monitoring visits will occur every 6 to 12 months, lasting up to 15 years depending on surgeries and follow-up. Researchers will assess disease-free intervals between surgeries and characterize tumor features over time to better understand GIST progression and outcomes.
CONDITIONS
Brief Title
Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological confirmation or clinical presentation suspicious of GIST
- Age 6 years or older
- ECOG performance status 2 or lower (Karnofsky or Lansky 60% or higher)
- Ability to understand and willingness to sign informed consent (participant or parent/guardian)
You will not qualify if you...
- Non-modifiable medical conditions that would prevent cytoreductive surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 10 years before and 5 years after surgery
Participants with histologically confirmed or suspicious GIST are actively monitored with visits every 9 to 15 months to assess disease status before and after surgical interventions.
Visits every 9 to 15 months
Duration - Variable, depending on individual surgical procedures
Participants who undergo surgical resection or cytoreduction of GIST tissue receive surgery and immediate post-operative care as clinically indicated.
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
S
Stephanie N Canady, R.N.
A
Andrew M Blakely, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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