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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Radboud University
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01727908
First received: November 8, 2012
Last updated: November 16, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Malignant Neoplasm of Stomach
Carcinoma, Diffuse Type
Intestinal Type Adenocarcinoma of Stomach
Relative (Related Person)
Other: Endoscopy with staining of the mucosa

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Screening for Familial Gastric Cancer in First Degree Relatives

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: November 2012
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727908

Contacts
Contact: Tanya M Bisseling, M.D. Ph.D. 0031-24-3616999 T.Bisseling@mdl.umcn.nl
Contact: Joep Endedijk, B.Sc. 0031-24-2616999 J.Endedijk@mdl.umcn.nl

Locations
Netherlands
Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Po Box 9101, Netherlands, 6500HB
Contact: Tanya M Bisseling, M.D.Ph.D.    0031-24-3616999    T.Bisseling@mdl.umcn.nl   
Contact: Joep Endedijk, B.Sc.    0031-24-3616999    J.Endedijk@mdl.umcn.nl   
Principal Investigator: Tanya M Bisseling, M.D.Ph.D.         
Sponsors and Collaborators
Radboud University
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
  More Information

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01727908     History of Changes
Other Study ID Numbers: Protocol ID 2012/270
Study First Received: November 8, 2012
Last Updated: November 16, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:
Familial Gastric Cancer Screening

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on October 19, 2014