Clinical trial · Observational
Comprehensive Genomic Profiling Combined With Real Life Data of "The German-Registry of Incidental Gallbladder Carcinoma"
Comprehensive Genomic Profiling Combined With Real Life Data of "The German-Registry of Incidental Gallbladder Carcinoma" the CONGENIAL Analysis Sub-study of the GR
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Multicenter German- Registry of Incidental Gallbladder Carcinoma combining clinical real-world data and comprehensive genomic profiling. The registry collects medical data from clinical observation and molecular data derived from archival tumor tissue samples but does not define any medical intervention nor does it evaluate the efficacy or safety of the treatment decision made by the investigator.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gallbladder Carcinoma | Gallbladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- overall survival
- timeFrame
- Through study completion, an average of 2 years
- description
- Overall Survival is defined as the time from date of first surgery, to the date of death (due to any cause).
- measure
- proportion of patients with genomic alterations
- timeFrame
- Through study completion, an average of 2 years
- description
- The primary outcome variable of the molecular sub-project is the proportion of patients with actionable genomic alterations, defined as number of patients with actionable mutations divided by the number of patients with completed F1 CDx testing. Additionally, the two-sided 95% exact confidence interval (Clopper-Pearson) will be given.
Secondary outcomes (1)
- measure
- The proportion of patients with actionable genomic alterations in all patients
- timeFrame
- Through study completion, an average of 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Histologically confirmed diagnosis of incidental gallbladder carcinoma * Patient ≥ 18 years old * Patient already deceased * Available tumor tissue (FFPE block) Exclusion Criteria: Patient under 18 years of age
References
Publications (0)
Data not yet available