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Co-clinical establishment of a prospective clinical database and biobank of core biopsy material from metastases of patients with stage IV PDAC under real-life conditions for the clinical validation of the two-tiered PREDICT-PACA approach to precision medicine

Co-clinical establishment of a prospective clinical database and biobank of core biopsy material from metastases of patients with stage IV PDAC under real-life conditions for the clinical validation of the two-tiered PREDICT-PACA approach to precision medicine - PREDICT-PACA

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00022429
Enrollment
144
Registered
2022-02-24
Start date
2021-04-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

C25

Interventions

Group 1: PDAC Stage 4

Sponsors

Klinikum der Universität München, Campus Großhadern
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • signed informed consent • age =18 years • suspected metastatic pancreatic cancer to be the most likely diagnosis • clinical indication for a core biopsy of metastases • eligibility for one of the three chemotherapeutical regimens: G, G+nabP or FOLFIRINOX

Exclusion criteria

Exclusion criteria: • age <18 year • patient is unfit for chemotherapy • concurrent active cancer treatment at the time of screening • concurrent other active malignancy • contraindication for fine needle biopsy • pregnancy, breast feeding • conditions preventing structured follow-up within the boundaries of the study protocol

Design outcomes

Primary

MeasureTime frame
The response to 1st and 2nd chemotherapy in comparison to response predicted by the RNA-based signatures using transcriptome data from fine needle biopsies of metastases of patients with stage IV PDAC.

Secondary

MeasureTime frame
i) The generation of a platform for simultaneous search for alternative treatments as rescue treatments once standard 1st and 2nd line treatments have failed, based on drug screening of patient derived organoids and identification of actionable mutations. ii) The feasibility to perform comprehensive IHC-multiplex analysis on fine needle biopsies of liver metastases.

Countries

Germany

Contacts

Public ContactGeorg Beyer

Klinikum der Universität München, Campus Großhadern

georg.beyer@med.uni-muenchen.de+49894400

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026