MedTrace Logo

Biopsy Technique for Endoscopic Surveillance of Hereditary Diffuse Gastric Cancer

NCT03950908 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-05-20

No results posted yet for this study

Summary

Germline mutation in e-cadherin gene (CDH1) is found in approximately 25% to 30% of individuals fulfilling the clinical criteria for hereditary diffuse gastric cancer (HDGC). Prophylactic gastrectomy is the mainstay of the management of cases with pathogenetic CDH1 mutation. However, some individuals refuse gastrectomy and prefer to delay it for medical or psychosocial reasons. For these patients as well as for those in which a pathogenetic mutation is not found, endoscopic surveillance is recommended. The suggested endoscopic protocol involves targeted as well as 30 random biopsies, which is tedious and time-consuming . In order to save time, two specimens can be taken during a single passage of the biopsy forceps ("double-bite" technique). The aim of this study was to determine the adequacy and utility of the "double-bite" technique in patients undergoing surveillance for HDGC as compared to the standard "single-bite technique".

Conditions

  • Hereditary Diffuse Gastric Cancer

Interventions

OTHER

Single bite biopsy technique

During biopsy collection one specimen will be retrieved during a single passage of the biopsy forceps.

OTHER

Double bite biopsy technique

During biopsy collection two specimens will be retrieved during a single passage of the biopsy forceps.

Sponsors & Collaborators

Principal Investigators

  • Massimiliano di Pietro, MD · MRC Cancer Unit.University of Cambridge.

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-12
Primary Completion
2018-12-13
Completion
2018-12-13

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03950908 on ClinicalTrials.gov