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Protocol Details

Phase II Randomized Trial of Bethesda Protocol Compared to Cambridge Method for Detection of Early Stage Gastric Cancer in CDH1 Mutation Carriers

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-C-0150

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Adults who are or may become unable to consent;
Children

Keywords

Diagnostic;
Diagnosis;
HDGC;
SRCC;
Confocal Endoscopic Microscopy (CEM)

Recruitment Keyword(s)

None

Condition(s)

Gastric Cancer;
Gastric Neoplasms;
Gastric Adenocarcinoma

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Device: Cellvizio (Registered trademark)Real-Time In Vivo Cellular Imaging Platform with Confocal Miniprobes
Device: Olympus GIF 190 endoscope

Supporting Site

National Cancer Institute

Background:

Some people have a mutation in the 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.

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Eligibility

INCLUSION CRITERIA:

-An individual who harbors a pathogenic, or likely pathogenic, 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.

EXCLUSION CRITERIA:

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

-Unstable angina or recent (within 3 months) myocardial infarction.

-Any clinical contraindication to general anesthesia.

Re-Enrollment:

INCLUSION CRITERIA:

-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)


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Jeremy L. Davis, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-3742
10 CENTER DR
BETHESDA MD 20892
(240) 858-3731
jeremy.davis@nih.gov

Jamie Kirkpatrick, R.N.
National Cancer Institute (NCI)

(240) 760-7533
jamie.kirkpatrick@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT04535414

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