Pancreas CancerAMETHYSTNCT02089269
Tumor Registry Pancreatic Cancer
An observational study of Pancreas Cancer, run by iOMEDICO AG at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- How many people
- 2,325 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2013to Jun 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pancreatic cancer undergoing antineoplastic treatment.
Who may be able to join
- 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
Who cannot join
- No pancreatic cancer
- Below 18 years and older
- No antineoplastic treatment
- Date of consent later than 2 weeks after start of first-line treatment
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- 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
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Treatment reality in Germany
description of treatments selected for patients per line of therapy over the course of the project
Measured: over 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startDec 2013
- Primary completion14 Apr 2022
- Study completionJun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by iOMEDICO AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,325 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susanna Hegewisch-Becker, Prof. MD, Study chair, Outpatient Clinic, Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089269
- Sponsor's protocol ID
- iOM-01281
- Other IDs
- Tumorregister Pankreaskarzinom
- Acronym
- AMETHYST
- Status last verified
- Oct 2024
- First submitted
- 14 Mar 2014
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30006989Marschner 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.
PubMed 36053905Marschner 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.
PubMed 38956837
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02089269
- Acronym / sponsor ID
- AMETHYST / iOM-01281
- Conditions
- Pancreas Cancer
- Keywords
- pancreatic neoplasms, neoplasms, registry, advanced pancreatic cancer, health services research, epidemiology, Germany, palliative treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,325 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- 14 Apr 2022 (actual)
- Study completion
- Jun 2024 (actual)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pancreatic cancer undergoing antineoplastic treatment.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- No pancreatic cancer
- Below 18 years and older
- No antineoplastic treatment
- Date of consent later than 2 weeks after start of first-line treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Background: PubMed 30006989Hegewisch-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.
- Background: PubMed 36053905Marschner 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.
- Background: PubMed 38956837Marschner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanna Hegewisch-Becker, Prof. MD study chair
Outpatient Clinic, Hamburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Cancer, run by iOMEDICO AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment reality in Germany (time frame: over 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02089269, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.