Prospective Evaluation and Molecular Profiling in People With Gastric Tumors
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|ClinicalTrials.gov Identifier: NCT03027427|
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : September 3, 2020
Certain stomach cancers are rare, but they have high mortality rates. Researchers want to learn more about gastric (stomach) tumors. In this study, they want to collect data from people who have stomach cancer or are at risk to get it. This data will be used to see if the people can be in other studies.
To study tissue from stomach tumors and find people eligible for more studies on gastric cancer.
Age greater than or equal to 2 years old who have or may have stomach cancer, lesions that may be related to stomach cancer, or an inherited disorder that leads to stomach cancer.
Participants will be screened with:
Blood and urine tests
Scans or ultrasound.
For the scans, participants lie in a machine that takes pictures. For some scans, they will swallow or be injected with a small amount of radioactive material. Special cameras will show the material in the body.
Tumor sample taken with a needle or surgery
Some participants will have an endoscopy. A long, flexible tube with a camera will be inserted through the mouth into the stomach. The tube will collect tissue from the stomach.
Some participants may have follow-up visits. Some may be invited to join other studies. Others will be contacted by phone to see how they are doing.
|Condition or disease|
|Stomach Neoplasms Stomach Cancer|
- Greater than 90% of gastric tumors are of epithelial origin and are classified as adenocarcinomas; the remainders include GIST, carcinoid and lymphoma
- Gastric adenocarcinoma is rare in the United States (incidence 7.4 per 100,000)
- Mortality rates are high with an estimated 5-year overall survival of 25% - 30%
- Up to 3% of gastric adenocarcinomas occur as part of a heritable cancer syndrome
- Molecular sub-classification of gastric adenocarcinomas has been reported, however translation of these findings into clinical management of patients has yet to occur
- To permit clinical and laboratory evaluation and molecular profiling of tumor tissue from patients with gastric malignancies or non-invasive (neoplastic) conditions
- Assess eligibility for enrollment in studies of gastric cancer conducted in the CCR
- To allow long-term follow up of patients with gastric tumors, or heritable gastric malignancy syndromes, to support clinical and preclinical research particularly related to molecular alterations in gastric tumors and their response to therapy
Patients with the following are eligible:
- Malignant or non-invasive, neoplastic lesions of the stomach confirmed by histopathology or cytopathology;
- Suspicious lesion not yet confirmed, but considered likely related to the stomach pending further evaluation;
- Confirmed, deleterious germline mutation (including but not limited to HDGC, GAPPS) known to predispose to gastric tumors;
- Confirmed or suspicious heritable gastric malignancy disorder;
- Clinically suspicious personal or family medical history of gastric cancer or gastric cancer syndrome that warrants genetics evaluation.
- Age greater than or equal to 2 years.
- This protocol is designed to facilitate clinical evaluation, molecular tumor profiling, and long-term follow up of patients with gastric tumors
- Patients will be screened and clinical evaluation performed to determine eligibility for other CCR trials for gastric tumors
- No investigational treatment will be administered and no procedures will be done for only research purposes on this protocol.
- It is anticipated that the protocol will enroll a maximum of 250 patients.
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Prospective Evaluation and Molecular Profiling in Patients With Gastric Tumors|
|Actual Study Start Date :||February 1, 2017|
|Estimated Primary Completion Date :||August 31, 2026|
|Estimated Study Completion Date :||December 31, 2026|
Patients with confirmation of, or suspicion of, a heritable gastric malignancy disorder
- Determination of eligibility [ Time Frame: At intial visit ]determination of eligibility for enrollment in studies of gastriccancer conducted in the CCR
- Clinical and laboratory evaluation and molecular profiling of tumor tissue [ Time Frame: at initial visit and as clinically indicated ]Tissue samples collected to permit clinical and laboratory evaluation and molecular profiling of tumor tissue from patients with gastric malignancies or non-invasive (neoplastic) conditions
- Long-term follow up to support clinical and preclinical research [ Time Frame: follow up ]long-term follow up of patients with gastric tumors, or heritable gastric malignancy syndromes, to support clinical and preclinical research particularly related to molecular alterations in gastric tumors and their response to therapy
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): NCT03027427
|Contact: Rebecca S Trupp, R.N.||(240) firstname.lastname@example.org|
|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:||Jeremy L Davis, M.D.||National Cancer Institute (NCI)|