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VONKO-030/ReGALLY: A Resectable GALLbladder and bile duct cancer studY based on real-world data from federal state cancer registries in Germany

VONKO-030/ReGALLY: A Resectable GALLbladder and bile duct cancer studY based on real-world data from federal state cancer registries in Germany - VONKO-030/ReGALLY

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00039897
Enrollment
25000
Registered
2026-06-09
Start date
2026-06-15
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C24

Interventions

Group 1: A retrospective analysis of all patients diagnosed with bile duct cancer in Germany between 2005 and 2026.

Sponsors

AstraZeneca GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: Patients 1. with newly diagnosed BTC (ICD-10 C22.1, C23, C24.0, C24.8, D01.5) from the year of diagnosis 2005 onwards 2. with Morphology (ICD-O-3): Adenocarcinoma 8140–8149, 8160–8163, 8190–8221, 8250–8552, 8570–8576, 8940–8941, 9110; adenosquamous carcinoma 8560 3. residing in the relevant federal state at the time of diagnosis 4. with at least one day of survival / follow-up period 5. additionally for oBDS-ZfKD and oBDS-LKR (= clinical data): a. Year of diagnosis 2020 or later b. Resectability approximated via TNM M0 category. c. Surgery with curative intent within 6 months of diagnosis d. Surgical outcome: macroscopically complete resection (R0 or R1).

Exclusion criteria

Exclusion criteria: 1. The case is known to the register solely on the basis of a. a death certificate (DCO case) b. a pathology report c. a follow-up report d. a report to the tumour board e. a combination of the aforementioned report types 2. Unknown vital status at the end of the follow-up period 3. Survival time of 0 days 4. Additionally for oBDS-ZfKD and oBDS-LKR (= clinical data): a. Unresectable BTC

Design outcomes

Primary

MeasureTime frame
Distribution of primary treatment modalities (e.g. surgery alone; surgery + neoadjuvant/adjuvant systemic therapy) as well as the frequency and type of follow-up treatments

Secondary

MeasureTime frame
- Overall survival (OS); progression/recurrence, where available - Reasons for discontinuation, where available - Incidence and mortality rates - Stage distribution - Proportions of tumour localisations

Countries

Germany

Contacts

Public ContactAnnika Waldmann

Universität zu Lübeck, Institut für Sozialmedizin und Epidemiologie

annika.waldmann@uksh.de+49 451 500-51240

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026