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Observational Study of GISTs for Research and Analysis

This observational study aims to understand Gastrointestinal Stromal Tumors (GISTs), especially those that are wild-type (WT) or resistant to standard treatments like tyrosine kinase inhibitors (TKIs). Researchers will follow people with GISTs and collect tumor tissue to study in the lab. This will help them develop new ways to treat this rare cancer. You may be eligible if you are 6 years or older and have a GIST. The study will track how long patients remain disease-free after surgery for at least five years. This research is important because it helps scientists find new targets for treatment.

Study design
This is an observational study with a planned enrollment of 400 participants. It is designed to follow patients with GISTs over time.
What's involved
You will have your medical records and samples reviewed. You will also have a medical history and physical exam, give blood samples, and may have a cheek swab and CT scan. You will enroll in one other NIH study and may be asked to join two optional NIH studies.
Compensation
Not stated in the trial record.
Follow-up
You will be followed with surveillance every 6-12 months and at the time of surgery, until 5 years after your last surgical resection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04557969

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

Recruiting
Not specifiedAges 6+Observational
National Cancer Institute (NCI)
~400 participants
Updated 2026-08-17 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate and follow patients with GISTs, particularly WT or treatment-refractory non-WT, to support translational research for this rare disease
Measured over on-going
+1 more outcome measured

Conditions

Gastric Cancer
Gastric Neoplasm
Gastrointestinal Stromal Sarcoma
Gastrointestinal Stromal Neoplasm
Gastrointestinal Stromal Tumor (GIST)

Explore related trials

Gastrointestinal Stromal Tumor

NCT04557969

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • National Institutes of Health Clinical Center

    Bethesda, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Andrew M Blakely, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Stephanie N Canady, R.N.
[email protected]
(240) 858-7573
Email the study team

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Evaluate and follow patients with GISTs, particularly WT or treatment-refractory non-WT, to support translational research for this rare diseaseon-going

    Patients with non-WT GIST and WT GIST will have the durations of the DFIs described both within each patient as their own control and across patients. Analyses will be done separately for those with WT GIST and those with non-WT GIST as well as for all patients combined.

  • Assess disease-free intervals (DFIs) between surgical resection of disease for at least 5 yearssurveillance every 6-12 months and time of surgery, until 5 years after last surgical resection (relative to the last resection performed)

    Surveillance every 6-12 months and time of surgery, by tumor measurement and imaging studies, to assess disease-free intervals (DFIs) between surgical resection of disease for at least 5 years.