Tumor Registry Pancreatic Cancer (AMETHYST)

March 8, 2024 updated by: iOMEDICO AG

Clinical Registry on Treatment Reality and Sequential Treatments of Patients With Resectable or Locally Advanced/Metastatic Pancreatic Cancer in Real-life Practice in Germany

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

2325

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BW
      • Freiburg, BW, Germany
        • iOMEDICO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with pancreatic cancer undergoing antineoplastic treatment.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment reality in Germany
Time Frame: over 5 years
description of treatments selected for patients per line of therapy over the course of the project
over 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iOMEDICO AG

Investigators

  • Study Chair: Susanna Hegewisch-Becker, Prof. MD, Outpatient Clinic, Hamburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

April 14, 2022

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

March 14, 2014

First Submitted That Met QC Criteria

March 14, 2014

First Posted (Estimated)

March 17, 2014

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iOM-01281
  • Tumorregister Pankreaskarzinom (Other Identifier: iOMEDICO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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