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
Recruiting
- Conditions
- C25Malignant neoplasm of pancreas
- Registration Number
- DRKS00022429
- Lead Sponsor
- Klinikum der Universität München, Campus Großhadern
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 144
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
• 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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.