Prospective Evaluation and Molecular Profiling in People With Gastric Tumors

Study Overview
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Brief Summary
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Background: 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. Objective: To study tissue from stomach tumors and find people eligible for more studies on gastric cancer. Eligibility: 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. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Heart 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. ...

Detailed Description
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Background: 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 Objectives: 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 Eligibility: 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. Design: 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.

Official Title
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Prospective Evaluation and Molecular Profiling in Patients With Gastric Tumors

Conditions
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Stomach Neoplasms, Stomach Cancer

Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: Patients with the following are eligible: Malignant or non-invasive, neoplastic lesions of the stomach confirmed by histopathology or cytopathology in a CLIA-certified laboratory OR --Suspicious lesions not yet confirmed, but considered likely to be related to the stomach pending further evaluation OR 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. Patients must have an ECOG performance score of 0-2. Age greater than or equal to 2 years. Note: Patients greater than or equal to 2 and less than or equal to 18 years of age may only participate in research sample collection if the tissue acquisition is performed during a clinically indicated surgical procedure, and the sampling of tissue, blood and urine does not add risk to the clinically indicated procedures. The patient is a candidate for the clinically indicated medical evaluations that are being offered Ability of subject, their parents/guardians or legally authorized representative (LAR) to understand and must be willing to sign a written informed consent document. EXCLUSION CRITERIA: Candidates who do not meet the inclusion criteria.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients with confirmation of, or suspicion of, a heritable gastric malignancy disorder | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term follow up to support clinical and preclinical research | long-term follow up of patients with gastric tumors, or heritable gastric malignancy syndromes screened on this study, to support clinical and preclinical research particularly related to molecular alterations in gastric tumors and their response to therapy | follow up | 
| Determination of eligibility | determination of eligibility for enrollment in studies of gastric cancer conducted in the CCR | at initial visit | 
| Clinical and laboratory evaluation and molecular profiling of tumor tissue | 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 | at initial visit and as clinically indicated | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Heritable Gastric Malignancy, Molecular Profiling, Molecular Alterations