Screening for Familial Gastric Cancer in First Degree Relatives
Conditions
Malignant Neoplasm of Stomach - Carcinoma, Diffuse Type - Intestinal Type Adenocarcinoma of Stomach - Relative (Related Person)
Conditions: official terms
Adenocarcinoma - Neoplasms - Stomach Neoplasms
Conditions: Keywords
Familial Gastric Cancer Screening
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Intervention
Name: Endoscopy with staining of the mucosa
Type: Other
Overall Status
Recruiting
Summary
The purpose of this study is to determine whether staining of the gastric mucosa increases the number of detected (pre)malignant foci of intestinal and diffuse type gastric cancer, in first degree relatives of individuals with familial gastric cancer.
Detailed Description
Rationale:

Familial gastric cancer (FGC) concerns about 10% of all gastric cancers. It has an impressive impact on both emotional and physical wellbeing of first degree relatives of patients with (early) onset of gastric cancer. FGC can in 1-3% be attributed to one single hereditary syndrome, the hereditary diffuse gastric cancer (HDGC). HDGC is associated with a CDH1 mutation in about 40 % of the cases. In case there is no CDH1 mutation, referred to as familiar diffuse gastric cancer (FDGC), it remains uncertain how to guide and/or screen family members. The same applies for the rare familial intestinal type gastric cancer (FIGC).

Aim:

In this study we want to determine the value of endoscopic screening in members of families with FGC, both FDGC and FIGC. Also, we will analyze the associations of life style factors, including dietary habits with the development of FDGC, to be able to built preventive strategies. Finally, we want to assess the psychological impact of our screening protocol.

Objective:

Primary, to determine whether staining of the gastric mucosa increases the number of detected (pre)malignant foci of diffuse type gastric cancer, in individuals from families with FDGC as well as dysplastic, adenomatous and early intestinal cancers in individuals from families with FIGC. Secondary: A To determine the optimal pathological work-up the detection rate of (pre-)malignancy. B To determine clinical and life style factors that are associated with the two types of FGC. C To determine the psychosocial impact of the screening protocol in this population. D To develop a strategy for screening individuals from FGC families and creative advise for preventive measures.

Study design:

A randomized controlled trial included in a prospective cohort analysis.

Study population:

All (first degree) relatives , from 18 years and older from patients who fulfill the criteria for a FGC. These are; 1] all first degree relatives of an individual with diffuse gastric cancer, without proven CDH1 mutation, or members from families with 2] 2 or more individuals with gastric carcinoma, at least one < 50 yrs, or 3] 3 or more individuals with gastric carcinoma, any age, any type, or 4] 1 individual with any type gastric carcinoma < 40 yrs.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- adult (≥ 18 yrs), female and male relatives

- fully legal competent (to simplify the common consent agreement for blood withdrawal, DNA analysis and serial endoscopies.)

- individuals that signed the common consent agreement

- first degree relative of an individual with diffuse gastric cancer from a FDGC-family, without proven mutation,

- OR: 2 or more individuals with gastric carcinoma, at least one < 50 yrs

- OR: 3 or more individuals with (diffuse/intestinal/other type) gastric carcinoma, any age

- OR 1 individual with any type gastric carcinoma < 40 yrs

Exclusion Criteria:

- immature individuals

- actual gastric ulcer or gastric bleeding

- previous diagnosis of gastric cancer

- hypersensitivity to Indigocarmine

- individuals with co-morbidity which might increase the sedation and/or endoscopy risk: COPD Gold III/IV Cardiac failure Increased bleeding tendency or use of medication which increases bleeding tendency
Location
Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre
Nijmegen, Po Box 9101, Netherlands
Status: Recruiting
Contact: Tanya M Bisseling, M.D.Ph.D. - 0031-24-3616999 - T.Bisseling@mdl.umcn.nl
Start Date
November 2012
Completion Date
November 2018
Sponsors
Radboud University
Source
Radboud University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page