Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT03030404
Eligibility Criteria:
-INCLUSION CRITERIA:
1. 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.
2. 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.
3. Ability of subject or legally authorized representative (LAR) to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
None.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT03030404
Study Brief:
Protocol Section:
NCT03030404