Recruiting

Surgery

Sponsor:

National Cancer Institute (NCI)

Code:

NCT04557969

Conditions

Gastric Cancer

Gastric Neoplasm

Gastrointestinal Stromal Sarcoma

Gastrointestinal Stromal Neoplasm

Gastrointestinal Stromal Tumor (GIST)

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Gastric Cancer

Gastric Neoplasm

Gastrointestinal Stromal Sarcoma

Gastrointestinal Stromal Neoplasm

Gastrointestinal Stromal Tumor (GIST)

Study ID

NCT04557969

Start date

Dec 18, 2020

Status verified date

Feb 4, 2026

Completion date

Dec 30, 2040

Anticipated

Primary completion date

Dec 30, 2040

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

1/ Cohort 1

Patients with histologically confirmed or clinical presentation suspicious of GIST

Primary outcome measure

  • Evaluate and follow patients with GISTs, particularly WT or treatment-refractory non-WT, to support translational research for this rare disease [ Time Frame: on-going ]
  • 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) ]

Central Contacts and Locations

Central contacts

Stephanie N Canady, R.N.

(240) 858-7573stephanie.canady@nih.gov

Andrew M Blakely, M.D.

(240) 760-7647andrew.blakely@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

888-624-1937

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Aug 17, 2026

Last verified

Feb 4, 2026

Keywords

  • Tyrosine Kinase Inhibitor (TKI) Therapy
  • Wild-Type GISTs (WT GISTs)
  • PDGFRA Mutation
  • KIT Mutation
  • SDH Mutation
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-08-17.