Tumor Registry Pancreatic Cancer

NCT ID: NCT02089269

Last Updated: 2025-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2325 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreas Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

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

No interventions assigned to this group

Cohort 2

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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iOMEDICO AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susanna Hegewisch-Becker, Prof. MD

Role: STUDY_CHAIR

Outpatient Clinic, Hamburg

Locations

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iOMEDICO

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 30006989 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36053905 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38956837 (View on PubMed)

Other Identifiers

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Tumorregister Pankreaskarzinom

Identifier Type: OTHER

Identifier Source: secondary_id

iOM-01281

Identifier Type: -

Identifier Source: org_study_id

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