NCT04535414CompletedPhase 2
Phase II Randomized Trial of Bethesda Protocol Compared to Cambridge Method for Detection of Early Stage Gastric Cancer in CDH1 Mutation Carriers
Source: ClinicalTrials.gov · Last updated 17 Jan 2025
Brief summary (registry, in English)
Background: Some people have a mutation in the cadherin-1 gene (CDH1) gene that is known to lead to stomach cancer. They are advised to get regular endoscopies with biopsies even if their stomach appears normal. The endoscopy method currently used is called the 'Cambridge Method.' Researchers want to test a new method called the 'Bethesda Protocol.' Objective: To compare the Cambridge Method and Bethesda Protocol and find out which is more efficient in catching early signs of cancer. Eligibility: Adults age 18 and older who have a mutation in the CDH1 gene. Design: Participants will be screened with a review of their medical history, medical records, and physical status. Participants will be put into group 1 (Bethesda Protocol) or group 2 (Cambridge Method). Participants will have a physical exam. They will have endoscopy. For this, they will be put under general anesthesia. They will wear compression cuffs around their legs to prevent blood clots. A lighted tube will be inserted into their mouth and go down to their stomach. For group 1 participants, 88 pieces of tissue will be taken from 22 areas of their stomach. For group 2 participants, 30 pieces of tissue will be taken from 6 areas of their stomach. Then group 2 will be injected with a contrast dye. A microscope will be inserted, and more samples will be taken. About 14 days later, participants will have a follow-up visit or phone call. They may give stool samples every 3 to 6 months for 12 months for research purposes. Participants may have another endoscopy 6-18 months later.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 195 (actual)
- First submitted
- 1 Sept 2020
- Start date
- 22 Jun 2023
- Primary completion date
- 12 Sept 2024
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04535414
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 195
- From 22 Jun 2023 to the primary completion date, 12 Sept 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 illness
- Any clinical contraindication (e.g., known bleeding disorder, thrombocytopenia) to endoscopic biopsy.
- Unstable angina or recent (within 3 months) myocardial infarction.
Other
- Any clinical contraindication to general anesthesia.
- Re-Enrollment:
Who the study is looking for
- Subject must have previously been enrolled on the study and must have undergone endoscopy. Note: Subject may re-enroll only once after initial endoscopy performed
- Subject must have clinical need for a repeat endoscopy
- Prior on-protocol endoscopy must have occurred at least 6 months (+/- 2 weeks) and no greater than 18 months (+/- 4 weeks)
Criteria the registry did not label
- INCLUSION CRITERIA:
- An individual who harbors a pathogenic, or likely pathogenic, cadherin-1 gene (CDH1) germline variant.
- Note: individuals with CDH1 variant classified as any of the following are not eligible:
- variant of uncertain significance
- benign
- likely benign.
- Age greater than or equal to 18 years.
- Physiologically able to undergo upper endoscopy.
- Ability of subject to understand and the willingness to sign a written informed consent document.
Age in the registry: 18 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.