Endoscopic Methods for Detecting Early Stomach Cancer

Phase 2

Waitlist Available

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.

Must not have

Any clinical contraindication (e.g., known bleeding disorder, thrombocytopenia) to endoscopic biopsy.

Any clinical contraindication to general anesthesia.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am 18 years old or older.

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I have a genetic mutation in the CDH1 gene.

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I am physically fit for an upper endoscopy procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have conditions like bleeding disorders that make biopsy unsafe for me.

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I cannot have general anesthesia due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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