NCT03030404Completed
Hereditary Gastric Cancer Syndromes: An Integrated Genomic and Clinicopathologic Study of the Predisposition to Gastric Cancer
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
Background: Gastric cancers are cancers of the stomach. Hereditary ones are passed from parent to child. Researchers want to gather data about hereditary gastric cancers. They want to learn about changes these cause in the body and about the genes involved. Objective: -To gather data about hereditary gastric cancer. Eligibility: * People at least 2 years old with personal or family history with a hereditary gastric cancer. * People at least 2 years old with gene changes that lead to such cancer or a lesion that may be hereditary. Design: * Participants will be screened in a separate protocol. * Participants will have: * Physical exam * Medical history * Blood tests * Scans * Photos of skin lesions and other findings * Gynecology consultation for women * Cheek swab (some participants) * For some participants, their relatives will be asked to join the study. * Some participants will be asked to allow the study to get stored tissue samples for relatives who have died. * Some samples will be sent to outside labs. All personal data will be protected. Samples will be destroyed when the study ends. * Participants will get the results of genetic testing. * Participants who cannot come to the NIH clinic may just give a cheek swab and have genetic testing done. * Some participants will be contacted for more testing.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 733 (actual)
- First submitted
- 24 Jan 2017
- Start date
- 27 Jan 2017
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- National Cancer Institute (NCI)
- NCT number
- NCT03030404
What you commit to
- Study type: Observational
- Participants enrolled: 733
- From 27 Jan 2017 to the primary completion date, 31 Mar 2025
- 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
- None.
Criteria the registry did not label
- -INCLUSION CRITERIA:
- An individual, or their family members, with any of the following:
- Fulfills clinical criteria for Hereditary Diffuse Gastric Cancer (HGDC) syndrome or Gastric Adenocarcinoma and Proximal Polyposis of the Stomach (GAPPS) syndrome.
- Clinically suspicious personal or family medical history of gastric cancer or gastric cancer syndrome that warrants genetics evaluation.
- Current diagnosis of gastric cancer and a germline mutation associated with a known cancer syndrome or an associated family history of gastric cancer.
- Harbors a pathogenic germline mutation known to predispose to gastric cancer.
- First-degree relatives, regardless of family history or personal history of cancer, with a documented deleterious germline mutation (including but not limited to CDH1, CTNNA1, SDH) known to predispose to gastric tumors.
- Diagnosis or suspicion of a premalignant or malignant stomach lesion of suspected hereditary etiology.
- Age \>= 2 years and older. Note: Patients under 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, saliva or urine collection does not add risk to the clinically indicated procedures.
- Ability of subject or legally authorized representative (LAR) to understand and the willingness to sign a written informed consent document.
Age in the registry: 2 years to - · Sex: All · Accepts 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.