Tumor Registry Pancreatic Cancer

Pancreas Cancer Clinical Trial

— AMETHYST  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02089269
• Other study ID #: iOM-01281
• Secondary ID: Tumorregister Pa
• Status: Active, not recruiting
• Start date: December 2013
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: iOMEDICO AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2325
• Est. completion date: September 2024
• Est. primary completion date: April 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
Germany	iOMEDICO	Freiburg	BW

Sponsors (1)

Lead Sponsor	Collaborator
iOMEDICO AG

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment reality in Germany	description of treatments selected for patients per line of therapy over the course of the project	over 5 years