An observational study in Gastric Cancer, Gastric Neoplasm and Gastrointestinal Stromal Sarcoma, sponsored by National Cancer Institute (NCI). Recruiting at 1 site in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by National Cancer Institute (NCI) · Observational
Objective:
To follow people with GISTs and collect tumor tissue so that it can be studied in the lab.
Eligibility:
People age 6 and older who have a GIST.
Design:
Participants will be screened with a review of their medical records and samples.
Participants will enroll in 1 other NIH study, and may be asked to enroll in 2 other optional NIH studies.
Participants will have a medical history and physical exam. Data about how they function in their daily activities will be obtained.
Participants may speak with a genetic counselor. They may have genetic testing.
Participants will give blood samples. They may have a cheek swab. For this, small brush will be rubbed against the inside of the cheek.
Participants may have a computed tomography (CT) scan of the chest, abdomen, and pelvis. Or they may have a CT scan of the chest and magnetic resonance imaging (MRI) of the abdomen and pelvis.
Participants will be monitored every 6-12 months at the NIH Clinical Center, for up to 10 years before having surgery. If they need surgery, it will be performed at the NIH. Then, they will be monitored every 6-12 months, for up to 5 years after surgery.
If a participant has surgery, tumor tissue samples and research specimen will be taken.
If a participant does not need surgery, their participation will end after 10 years. If they have surgery, the 5-year monitoring period will restart after each surgery.
...
Background:
Gastrointestinal stromal tumors (GISTs) are the most common gastrointestinal soft tissue sarcoma, but remain a rare disease entity.
Most GISTs are characterized by KIT or PDGFRA mutations, making them susceptible to tyrosine kinase inhibitor (TKI) therapy.
Wild-type (WT) GISTs are rarer tumors, usually characterized by SDH mutations and/or lack of KIT or PDGFRA mutations; paragangliomas are frequently associated with WT GISTs.
Non-WT GISTs may become refractory to TKI therapy, whereas WT GISTs are generally resistant to TKI therapy.
The primary treatment modality for GISTs is surgical resection, which may involve the stomach, liver, and/or peritoneal surfaces; most patients will require multiple operations to remove disease not responsive to systemic agents.
Investigational systemic therapies are limited by toxicity and/or lack of efficacy, resulting in an unmet need for novel treatment options.
Obtaining fresh tumor tissue is critical to the successful development of GIST models for drug research, as well as for next generation tumor genomic sequencing, and to help identify novel targets and/or agents for the treatment of WT and TKI-resistant non-WT GISTs.
Objective:
Evaluate and follow participants with GISTs, particularly WT and treatment-refractory non-WT, to support translational research for this rare disease
Assess disease-free intervals (DFIs) between surgical resection of disease for at least 5 years
Eligibility:
Participants with histologically confirmed or clinical presentation suspicious of GIST.
Design:
Prospective cohort study
Participants with histologically confirmed or clinical presentation suspicious of GIST will enroll on study and will have active surveillance every 9-15 months for up to 10 years prior to and up to 5 years after surgical resection and/or cytoreduction. As participants may have multiple resections during the course of the study, 5-year surveillance post-surgery may be initiated multiple times, relative to the last resection performed.
All participants enrolled will be evaluated for tumor resection or cytoreduction at the start of study and if appropriate, will be offered surgery, otherwise they will be on active surveillance until surgical resection or cytoreduction is clinically indicated.
It is expected that approximately 30-40 participants per year may enroll on this trial; the accrual ceiling will be set at 400 to permit accrual over a 10-year period.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 400 is above the median of 274 across 670 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Individuals with histologically confirmed or clinical presentation suspicious of GIST.
EXCLUSION CRITERIA:
- Non-modifiable medical comorbidities that would preclude cytoreductive surgery.
Patients with histologically confirmed or clinical presentation suspicious of GIST
Evaluate and follow patients with GISTs, particularly WT or treatment-refractory non-WT, to support translational research for this rare disease
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.
Time frame: on-going
Assess disease-free intervals (DFIs) between surgical resection of disease for at least 5 years
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.
Time frame: surveillance every 6-12 months and time of surgery, until 5 years after last surgical resection (relative to the last resection performed)
Characterize genomic and clinicopathologic features of GISTs
Characterization of the genomic and clinicopathologic features associated with GISTs.
Time frame: at clinical visits and follow-up
Plan to share: Yes — All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Supporting information: Study protocol, Sap, Icf
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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