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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.
In the largest cohort of IGBC patients ever analysed in such a comprehensive approach
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| Measure | Description | Time Frame |
|---|---|---|
| overall survival | Overall Survival is defined as the time from date of first surgery, to the date of death (due to any cause). | Through study completion, an average of 2 years |
| proportion of patients with genomic alterations | 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. | Through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with actionable genomic alterations in all patients | The proportion of patients with actionable genomic alterations in all patients, including those where no FoundationOne CDx test result may be obtained ± 95% confidence interval | Through study completion, an average of 2 years |
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Inclusion Criteria:
Histologically confirmed diagnosis of incidental gallbladder carcinoma
Exclusion Criteria:
Patient under 18 years of age
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adult patients with gallbladder carcinoma
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| Name | Affiliation | Role |
|---|---|---|
| Thorsten Götze, Prof. | Institute of clinical cancer research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frankfurter Institut für Klinische Krebsforschung IKF GmbH | Frankfurt am Main | 60488 | Germany |
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| ID | Term |
|---|---|
| D005706 | Gallbladder Neoplasms |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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archival tumor tissue samples
| D001660 |
| Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |