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NCT04535414 · ClinicalTrials.gov registry record · Phase 2
Phase II Randomized Trial of Bethesda Protocol Compared to Cambridge Method for Detection of Early Stage Gastric Cancer in CDH1 Mutation Carriers
A Phase 2 study of Gastric Cancer and Gastric Adenocarcinoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 195
- Enrollment target
- 1
- Study location
NCT04535414 is a Phase 2 study of Gastric Cancer and Gastric Adenocarcinoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 195 participants, below the 318-participant average among 153 other Gastric Cancer trials with a reported enrollment target (39% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04535414, a Phase 2 study of Gastric Cancer and Gastric Adenocarcinoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 195 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Cellvizio (Registered trademark) Real-Time In Vivo Cellular Imaging Platform with Confocal Miniprobes
- DEVICE Olympus Graphics Interchange Format (GIF) 190 endoscope
- PROCEDURE Gastric mucosal biopsy
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2023-06-22 |
| Est. Completion | 2025-01-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04535414
The ClinicalTrials.gov registry entry for NCT04535414 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 318-participant average among 153 other Gastric Cancer trials with a reported enrollment target (39% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Gastric Cancer appearing as the primary indexed condition, and to 3 interventions - of which Cellvizio (Registered trademark) Real-Time In Vivo Cellular Imaging Platform with Confocal Miniprobes is the first listed.
NCT04535414 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT04535414 about?
NCT04535414 is a clinical study titled "Phase II Randomized Trial of Bethesda Protocol Compared to Cambridge Method for Detection of Early Stage Gastric Cancer in CDH1 Mutation Carriers". 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 ...
What is the current status of trial NCT04535414?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 195 participants. The study started on 2023-06-22. Estimated completion is 2025-01-10.
What conditions does trial NCT04535414 study?
This clinical trial studies the following conditions: Gastric Cancer, Gastric Adenocarcinoma, Gastric Neoplasms.
What interventions are being tested in trial NCT04535414?
The interventions under investigation include: Cellvizio (Registered trademark) Real-Time In Vivo Cellular Imaging Platform with Confocal Miniprobes (DEVICE), Olympus Graphics Interchange Format (GIF) 190 endoscope (DEVICE), Gastric mucosal biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT04535414?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04535414 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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