Know Cancer

forgot password

Screening for Familial Gastric Cancer in First Degree Relatives

18 Years
Open (Enrolling)
Malignant Neoplasm of Stomach, Carcinoma, Diffuse Type, Intestinal Type Adenocarcinoma of Stomach, Relative (Related Person)

Thank you

Trial Information

Screening for Familial Gastric Cancer in First Degree Relatives


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


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.


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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

The percentage of increasement of endoscopic detection of (pre)malignant for gastric cancer by staining of the gastric mucosa.

Outcome Time Frame:

all patients will have a follow up of five years, during which four endoscopies will be performed

Safety Issue:


Principal Investigator

Tanya M Bisseling, M.D.Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

Protocol ID 2012/270



Start Date:

November 2012

Completion Date:

November 2018

Related Keywords:

  • Malignant Neoplasm of Stomach
  • Carcinoma, Diffuse Type
  • Intestinal Type Adenocarcinoma of Stomach
  • Relative (Related Person)
  • Familial Gastric Cancer Screening
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Carcinoma
  • Stomach Neoplasms