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

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

Gastrointestinal Stromal Tumor

Recruiting

Start Date 12/18/2020

Age of Trial (yrs) 3.4

All Gleevec-resistant Adjuvant Neoadjuvant First-line Stable disease

None

Curative

Specifically GIST and only GIST

200161 20-C-0161

National Cancer Institute

Audra A Satterwhite, R.N. (240) 858-3552 audra.satterwhite@nih.gov

Observational, prospective surgery trial.
Will admit international patients
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.

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 3 other 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 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.