Screening for Familial Gastric Cancer in First Degree Relatives (NCT01727908) | Clinical Trial Compass
TerminatedNot Applicable
Screening for Familial Gastric Cancer in First Degree Relatives
Stopped: guideline developed
Netherlands79 participantsStarted 2012-11
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The percentage of increasement of endoscopic detection of (pre)malignant for gastric cancer by staining of the gastric mucosa.
Timeframe: all patients will have a follow up of five years, during which four endoscopies will be performed