Screening for Familial Gastric Cancer in First Degree Relatives (FamGaCan)
|ClinicalTrials.gov Identifier: NCT01727908|
Recruitment Status : Active, not recruiting
First Posted : November 16, 2012
Last Update Posted : September 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasm of Stomach Carcinoma, Diffuse Type Intestinal Type Adenocarcinoma of Stomach Relative (Related Person)||Other: Endoscopy with staining of the mucosa||Not Applicable|
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).
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.
A randomized controlled trial included in a prospective cohort analysis.
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 (Clinical Trial)|
|Actual Enrollment :||79 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Screening for Familial Gastric Cancer in First Degree Relatives|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
|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
- 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 ]
- 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 ]
- 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 ]
- 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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727908
|Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre|
|Nijmegen, Po Box 9101, Netherlands, 6500HB|
|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|