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Endoscopic Methods for Detecting Early Stomach Cancer
Phase 2
Recruiting
Led By Jeremy L Davis, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than or equal to 18 years.
An individual who harbors a pathogenic, or likely pathogenic, CDH1 germline variant.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
Study Summary
This trial is comparing the Cambridge Method of endoscopy (where 30 pieces of tissue are taken from 6 areas of the stomach) to the Bethesda Protocol (where 88 pieces of tissue are taken from 22 areas of the stomach) to see which is more efficient in catching early signs of cancer.
Who is the study for?
This trial is for adults over 18 with a CDH1 gene mutation, which increases stomach cancer risk. They must be physically able to undergo an endoscopy and have had one previously through this study. People can't join if they have conditions that make anesthesia or biopsy risky, like bleeding disorders or recent heart problems.Check my eligibility
What is being tested?
The trial compares two methods of detecting early-stage gastric cancer in those at high risk due to the CDH1 mutation. The 'Bethesda Protocol' involves taking more tissue samples than the current 'Cambridge Method', which also uses a contrast dye and confocal microscopy for cell imaging.See study design
What are the potential side effects?
Potential side effects include risks associated with general anesthesia, discomfort from the endoscopic procedure, possible bleeding or infection from biopsies taken during the endoscopy, and reactions to any contrast dye used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have a genetic mutation in the CDH1 gene.
Select...
I am physically fit for an upper endoscopy procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine if Bethesda protocol provides improved sensitivity for detection of early stage gastric cancer in CDH1 germline mutation carriers compared to the Cambridge method
Secondary outcome measures
Define the false negative rate of SRCC detection using Bethesda protocol and Cambridge methods in patients who proceed to risk-reducing total gastrectomy
To estimate and compare the difference in crude cancer detection rates between endoscopy using the Bethesda protocol and the Cambridge method
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 1/ Arm 1Experimental Treatment2 Interventions
Bethesda protocol (investigational)with confocal endomicroscopy in assigned participants
Group II: 2/ Arm 2Active Control2 Interventions
Cambridge method (control) with confocal endomicroscopy in assigned participants
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,667 Previous Clinical Trials
40,925,782 Total Patients Enrolled
Jeremy L Davis, M.D.Principal InvestigatorNational Cancer Institute (NCI)
8 Previous Clinical Trials
2,969 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need another endoscopy.I do not have conditions like bleeding disorders that make biopsy unsafe for me.I am 18 years old or older.I have a genetic mutation in the CDH1 gene.I am physically fit for an upper endoscopy procedure.I cannot have general anesthesia due to health reasons.I have not had a recent heart attack or unstable chest pain in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: 2/ Arm 2
- Group 2: 1/ Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the Olympus GIF 180 endoscope adhere to FDA standards?
"Because there is only data supporting Olympus GIF 180 endoscope's safety and none for efficacy, it received a score of 2."
Answered by AI
Are people still being recruited to participate in this research?
"This particular trial, which was first made public on November 23rd, is not currently looking for patients to enroll. The most recent update to the study occurred on November 17th. Although this research isn't actively recruiting, there are 703 other trials with open enrollment at this time."
Answered by AI
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