Screening for Familial Gastric Cancer in First Degree Relatives (FamGaCan)

September 12, 2019 updated by: Radboud University Medical Center
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Po Box 9101
      • Nijmegen, Po Box 9101, Netherlands, 6500HB
        • Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Endoscopy without staining of the mucosa
Experimental: Endoscopy with staining of the mucosa.
Other: Endoscopy with staining of the mucosa
Staining of the gastric mucosa with acetic acid and Indigocarmine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percentage of increasement of endoscopic detection of (pre)malignant for gastric cancer by staining of the gastric mucosa.
Time Frame: all patients will have a follow up of five years, during which four endoscopies will be performed
all patients will have a follow up of five years, during which four endoscopies will be performed

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the optimal pathological work-up the detection rate of (pre-)malignancy, measured by the number of (pre) malignant foci found by the pathologist with different coloring and immunohistochemic techniques.
Time Frame: all patients will have a follow up of five years, during which four endoscopies with biopsy sampling will be performed
all patients will have a follow up of five years, during which four endoscopies with biopsy sampling will be performed
To determine the association of clinical and life style factors with the two type of Familial Gastric Cancer, partly assessed from the patients'clinical files (eg BMI), partly by assessment of possible risk factors in blood (eg Helicobacter Pylori).
Time Frame: after three years of follow up these data will be assessed
after three years of follow up these data will be assessed
To determine the psychosocial impact of the screening protocol in this population, measured as the amount of stress and anxiety by use of the Hospital Anxiety and Distress Scale and the amount of cancer-worry by use of the Cancer Worry Scale.
Time Frame: during the follow up period of five years, each patient will receive questionaires at six time points. Assessment of these data will be performed after finishing the follow-up of the last patient, about six years after the start of this study.
during the follow up period of five years, each patient will receive questionaires at six time points. Assessment of these data will be performed after finishing the follow-up of the last patient, about six years after the start of this study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Tanya M Bisseling, M.D.Ph.D., Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre
  • Principal Investigator: Fokko M Nagengast, M.D.Ph.D., Department of gastroenterology and hepatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

November 8, 2012

First Submitted That Met QC Criteria

November 12, 2012

First Posted (Estimate)

November 16, 2012

Study Record Updates

Last Update Posted (Actual)

September 16, 2019

Last Update Submitted That Met QC Criteria

September 12, 2019

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol ID 2012/270

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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