NCT04557969 Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis
| NCT ID | NCT04557969 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Gastric Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2020-12-18 |
| Primary Completion | 2040-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2020-12-18 with a primary completion date of 2040-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
* 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.
Contact & Investigator
Andrew M Blakely, M.D.
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT04557969 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04557969 currently recruiting?
Yes, NCT04557969 is actively recruiting participants. Contact the research team at stephanie.canady@nih.gov for enrollment information.
Where is the NCT04557969 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT04557969 clinical trial?
NCT04557969 is sponsored by National Cancer Institute (NCI). The principal investigator is Andrew M Blakely, M.D. at National Cancer Institute (NCI). The trial plans to enroll 400 participants.
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