Clinical trial · Interventional
Screening for Familial Gastric Cancer in First Degree Relatives
NCT01727908CI-TRIAL-00040625FamGaCanterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): guideline developed
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Diffuse Type | Diffuse-Type Adenocarcinoma | ALIAS | 0.90 |
| Intestinal Type Adenocarcinoma of Stomach | Gastric Neoplasm | PROBABILISTIC | 0.70 |
| Malignant Neoplasm of Stomach | Malignant Gastric Neoplasm | ALIAS | 0.90 |
| Relative (Related Person) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopy with staining of the mucosa | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Endoscopy without staining of the mucosa
- type
- EXPERIMENTAL
- label
- Endoscopy with staining of the mucosa.
- interventionNames
- Other: Endoscopy with staining of the mucosa
Primary outcomes (1)
- measure
- 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
Secondary outcomes (3)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.