Clinical trial NCT02089269: Tumor Registry Pancreatic Cancer
Official title: Clinical Registry on Treatment Reality and Sequential Treatments of Patients with Resectable or Locally Advanced/metastatic Pancreatic Cancer in Real-life Practice in Germany
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreas Cancer
Keywords: pancreatic neoplasms
neoplasms
registry
advanced pancreatic cancer
health services research
epidemiology
Germany
palliative treatment
palliative care
localized, resectable pancreatic cancer
adjuvant treatment
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
First posted: 2014-03-17
Enrollment: 2325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pancreatic cancer undergoing antineoplastic treatment.

Brief summary: The registry aims to collect and analyse information on the antineoplastic treatment of patients with unresectable locally advanced or metastatic pancreatic cancer, treated in palliative intention (cohort 1) and patients with localized, resectable pancreatic cancer treated in neo-adjuvant or adjuvant intention (cohort 2) in daily routine practice in Germany. The registry will follow up patients for two years. It will identify common sequences of treatments used as well as changes in the treatment of the disease. Health-related quality of life will be analysed during the course of the treatment (PanLife). Based on the available data a prognostic score will be developed.


Eligibility criteria: Inclusion Criteria:

* resectable or locally advanced/metastatic pancreatic cancer
* 18 years and older
* Antineoplastic treatment
* Date of consent no later than 2 weeks after start of first-line treatment

Exclusion Criteria:

* No pancreatic cancer
* Below 18 years and older
* No antineoplastic treatment
* Date of consent later than 2 weeks after start of first-line treatment

Primary outcomes:
measure: Treatment reality in Germany
timeFrame: over 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: iOMEDICO
state: BW
Study officials:
affiliation: Outpatient Clinic, Hamburg
name: Susanna Hegewisch-Becker, Prof. MD
role: STUDY_CHAIR
References:
citation: Hegewisch-Becker S, Aldaoud A, Wolf T, Krammer-Steiner B, Linde H, Scheiner-Sparna R, Hamm D, Janicke M, Marschner N; TPK-Group (Tumour Registry Pancreatic Cancer). Results from the prospective German TPK clinical cohort study: Treatment algorithms and survival of 1,174 patients with locally advanced, inoperable, or metastatic pancreatic ductal adenocarcinoma. Int J Cancer. 2019 Mar 1;144(5):981-990. doi: 10.1002/ijc.31751. Epub 2018 Oct 3.
citation: Marschner N, Hegewisch-Becker S, Reiser M, von der Heyde E, Bertram M, Hollerbach SH, Kreher S, Wolf T, Binninger A, Chiabudini M, Kaiser-Osterhues A, Janicke M; TPK-Group (Tumour Registry Pancreatic Cancer). FOLFIRINOX or gemcitabine/nab-paclitaxel in advanced pancreatic adenocarcinoma: A novel validated prognostic score to facilitate treatment decision-making in real-world. Int J Cancer. 2023 Feb 1;152(3):458-469. doi: 10.1002/ijc.34271. Epub 2022 Sep 22.
citation: Marschner N, Haug N, Hegewisch-Becker S, Reiser M, Dorfel S, Lerchenmuller C, Linde H, Wolf T, Hof A, Kaiser-Osterhues A, Potthoff K, Janicke M; TPK-Group (Tumour Registry Pancreatic Cancer). Head-to-head comparison of treatment sequences in advanced pancreatic cancer-Real-world data from the prospective German TPK clinical cohort study. Int J Cancer. 2024 Nov 1;155(9):1629-1640. doi: 10.1002/ijc.35071. Epub 2024 Jul 2.