NCT03027427Completed
Prospective Evaluation and Molecular Profiling in People With Gastric Tumors
Prospective Evaluation and Molecular Profiling in Patients With Gastric Tumors
Source: ClinicalTrials.gov · Last updated 28 Feb 2025
Brief summary (registry, in English)
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. ...
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 109 (actual)
- First submitted
- 18 Jan 2017
- Start date
- 1 Feb 2017
- Primary completion date
- 20 Jun 2024
- Lead sponsor
- National Cancer Institute (NCI)
- NCT number
- NCT03027427
What you commit to
- Study type: Observational
- Participants enrolled: 109
- From 1 Feb 2017 to the primary completion date, 20 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Candidates who do not meet the inclusion criteria.
Criteria the registry did not label
- INCLUSION CRITERIA:
- Patients with any of the following are eligible:
- Malignant or non-invasive, neoplastic lesions of the stomach confirmed by histopathology or cytopathology in a CLIA-certified laboratory;
- Suspicious lesions not yet confirmed, but considered likely to be 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.
- 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.
Age in the registry: 2 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.