Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04557969|
Recruitment Status : Recruiting
First Posted : September 22, 2020
Last Update Posted : March 21, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
To follow people with GISTs and collect tumor tissue so that it can be studied in the lab.
People age 6 and older who have a GIST.
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 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.
|Condition or disease|
|Gastric Cancer Gastric Neoplasm Gastrointestinal Stromal Sarcoma Gastrointestinal Stromal Neoplasm Gastrointestinal Stromal Tumor (GIST)|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Prospective Study of Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis|
|Actual Study Start Date :||December 18, 2020|
|Estimated Primary Completion Date :||December 30, 2040|
|Estimated Study Completion Date :||December 30, 2040|
1/ Cohort 1
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 [ Time Frame: on-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 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) ]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.
- Characterize genomic and clinicopathologic features of GISTs [ Time Frame: at clinical visits and follow-up ]Characterization of the genomic and clinicopathologic features associated with GISTs.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||6 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- Ability and willingness to enroll on 13C0176, "Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors".
- Non-modifiable medical comorbidities that would preclude cytoreductive surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04557969
|Contact: Audra A Satterwhite, R.N.||(240) firstname.lastname@example.org|
|Contact: Andrew M Blakely, M.D.||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Andrew M Blakely, M.D.||National Cancer Institute (NCI)|
|Responsible Party:||National Cancer Institute (NCI)|
|Other Study ID Numbers:||
|First Posted:||September 22, 2020 Key Record Dates|
|Last Update Posted:||March 21, 2023|
|Last Verified:||January 27, 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||.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.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
|Time Frame:||Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.|
|Access Criteria:||Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.@@@@@@Genomic data are made available via dbGaP through requests to the data custodians.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Tyrosine Kinase Inhibitor (TKI) Therapy
Wild-Type GISTs (WT GISTs)
Gastrointestinal Stromal Tumors
Sarcoma, Endometrial Stromal
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Neoplasms, Connective Tissue
Neoplasms, Complex and Mixed
Endometrial Stromal Tumors
Genital Neoplasms, Female