Screening for Familial Gastric Cancer in first degree relatives
- Conditions
- Familial Gastric Cancer1001801810017991
- Registration Number
- NL-OMON37219
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
1] Adult from age of 18 years, female and male relatives
2] Fully legal competent (to simplify the common consent agreement for blood withdrawal,
and serial endoscopies.)
3] Individuals that signed the common consent agreement
4] First degree relative of an individual with diffuse gastric cancer from a Familial Gastric Cancer-family:
o OR: 2 or more individuals with diffuse gastric carcinoma, at least one < 50 yrs
o OR: 3 or more individuals with (diffuse/intestinal/other type) gastric carcinoma, any age
o OR 1 individual with diffuse gastric carcinoma < 40 yrs
- immature individuals
- actual gastric ulcer or gastric bleeding
- previous diagnosis of cancer
- 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 (and cannot be stopped temporarily)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study outcome of this study is to determine if spraying of the<br /><br>gastric mucosa with acetic acid and Indigo carmine will increase the detection<br /><br>rate of these (pre)malignant lesions. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundary study paramers of this study are:<br /><br>A] To determine if standardized sampling, colouring and examination of the<br /><br>histological specimens will contribute to the detection of (pre-)malignant<br /><br>FDGC.<br /><br>B] To determine the optimal interval for endoscopic screening.<br /><br>C] To determine the contribution as well as association with clinical,<br /><br>life-style and dietary habits to the development of FGC.<br /><br>D] And finally, to determine the psychosocial impact of screening in<br /><br>individuals in this population.</p><br>