NCT02089269

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,325

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2022

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

January 30, 2025

Status Verified

October 1, 2024

Enrollment Period

8.4 years

First QC Date

March 14, 2014

Last Update Submit

January 28, 2025

Conditions

Pancreas Cancer

Keywords

pancreatic neoplasmsneoplasmsregistryadvanced pancreatic cancerhealth services researchepidemiologyGermanypalliative treatmentpalliative carelocalized, resectable pancreatic canceradjuvant treatment

Outcome Measures

Primary Outcomes (1)

  • Treatment reality in Germany

    description of treatments selected for patients per line of therapy over the course of the project

    over 5 years

Study Arms (2)

Cohort 1

2,200 patients with unresectable locally advanced or metastatic pancreatic cancer, treated in palliative intention

Cohort 2

125 patients with localized, resectable pancreatic cancer treated in neo-adjuvant or adjuvant intention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with pancreatic cancer undergoing antineoplastic treatment.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

iOMEDICO

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Location

Related Publications (3)

  • 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.

    PMID: 30006989BACKGROUND

  • 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.

    PMID: 36053905BACKGROUND

  • 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.

    PMID: 38956837BACKGROUND

MeSH Terms

Conditions

Pancreatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Susanna Hegewisch-Becker, Prof. MD

    Outpatient Clinic, Hamburg

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2014

First Posted

March 17, 2014

Study Start

December 1, 2013

Primary Completion

April 14, 2022

Study Completion

June 1, 2024

Last Updated

January 30, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)