Colorectal CancerTKKNCT00910819
Tumour Registry Colorectal Cancer
An observational study of Colorectal Cancer, run by iOMEDICO AG at 1 site in Germany.
Trial summary
To describe treatment reality of patients with colorectal cancer treated by office-based and clinic-based medical oncologists in Germany. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 7,000 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2006to Mar 2022
- How long will I take part?
- 3 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: Colorectal cancer patients undergoing antineoplastic treatment.
Who may be able to join
- Colorectal cancer
- 18 years and older
- Antineoplastic treatment
Who cannot join
- No colorectal cancer
- Below 18 years
- No antineoplastic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective and Retrospective Observation of the Adjuvant and Palliative Treatment Strategies in the Therapy of Colorectal Cancer in Germany
To describe treatment reality of patients with colorectal cancer treated by office-based and clinic-based medical oncologists in Germany.
Read the detailed description
The TKK is a prospective, longitudinal, nation wide cohort study with the purpose to record information on the antineoplastic treatment of colorectal cancer in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics, biomarker testing and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.
The impact of nutrition (CoNut) and physical activity (CoNut) on the course of the adjuvant disease will be examined, as well as long-term effects of adjuvant treatment (CoTox) and the final phase of the palliative process (CoLife). Based on the available data a prognostic score will be developed.
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Advanced Colorectal Cancer, Epidemiology, Health Services Research, Germany, Registry, Palliative Care, Palliative Treatment, Adjuvant Drug Therapy, Nutrition Assessment, Physical Activity
- Medical subject headings
- Colorectal Neoplasms, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Course of Antineoplastic Treatment
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startSep 2006
- Primary completionMar 2022
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal 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
- 7,000 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arbeitskreis Klinische Studien, Arbeitsgemeinschaft fur Internistische Onkologie
- Responsible party
- Sponsor
- Investigators
- Roland Schnell, MD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910819
- Sponsor's protocol ID
- IOM TKK
- Acronym
- TKK
- Status last verified
- Aug 2025
- First submitted
- 28 May 2009
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Marschner N, Frank M, Vach W, Ladda E, Karcher A, Winter S, Janicke M, Trarbach T. Development and validation of a novel prognostic score to predict survival in patients with metastatic colorectal cancer: the metastatic colorectal cancer score (mCCS). Colorectal Dis. 2019 Jul;21(7):816-826. doi: 10.1111/codi.14600. Epub 2019 Mar 18.
PubMed 30834622Marschner N, Arnold D, Engel E, Hutzschenreuter U, Rauh J, Freier W, Hartmann H, Frank M, Janicke M. Oxaliplatin-based first-line chemotherapy is associated with improved overall survival compared to first-line treatment with irinotecan-based chemotherapy in patients with metastatic colorectal cancer - Results from a prospective cohort study. Clin Epidemiol. 2015 Apr 20;7:295-303. doi: 10.2147/CLEP.S73857. eCollection 2015.
PubMed 25945067
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Retrospective Observation of the Adjuvant and Palliative Treatment Strategies in the Therapy of Colorectal Cancer in Germany
- ClinicalTrials.gov ID
- NCT00910819
- Acronym / sponsor ID
- TKK / IOM TKK
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Advanced Colorectal Cancer, Epidemiology, Health Services Research, Germany, Registry, Palliative Care, Palliative Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,000 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Collaborators
- Arbeitskreis Klinische Studien, Arbeitsgemeinschaft fur Internistische Onkologie
- Study start
- Sep 2006 (actual)
- Primary completion
- Mar 2022 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 1 Jun 2009 (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.
To describe treatment reality of patients with colorectal cancer treated by office-based and clinic-based medical oncologists in Germany.
Detailed description
The TKK is a prospective, longitudinal, nation wide cohort study with the purpose to record information on the antineoplastic treatment of colorectal cancer in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics, biomarker testing and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.
The impact of nutrition (CoNut) and physical activity (CoNut) on the course of the adjuvant disease will be examined, as well as long-term effects of adjuvant treatment (CoTox) and the final phase of the palliative process (CoLife). Based on the available data a prognostic score will be developed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colorectal cancer patients undergoing antineoplastic treatment.
Key inclusion criteria (3 listed)
- Colorectal cancer
- 18 years and older
- Antineoplastic treatment
Key exclusion criteria (3 listed)
- No colorectal cancer
- Below 18 years
- No antineoplastic 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
Course of Antineoplastic Treatment
Time frame: 5 years
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 28 Aug 2025.
- Background: PubMed 30834622Marschner N, Frank M, Vach W, Ladda E, Karcher A, Winter S, Janicke M, Trarbach T. Development and validation of a novel prognostic score to predict survival in patients with metastatic colorectal cancer: the metastatic colorectal cancer score (mCCS). Colorectal Dis. 2019 Jul;21(7):816-826. doi: 10.1111/codi.14600. Epub 2019 Mar 18.
- Results publication: PubMed 25945067Marschner N, Arnold D, Engel E, Hutzschenreuter U, Rauh J, Freier W, Hartmann H, Frank M, Janicke M. Oxaliplatin-based first-line chemotherapy is associated with improved overall survival compared to first-line treatment with irinotecan-based chemotherapy in patients with metastatic colorectal cancer - Results from a prospective cohort study. Clin Epidemiol. 2015 Apr 20;7:295-303. doi: 10.2147/CLEP.S73857. eCollection 2015.
- 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.
Roland Schnell, MD study chair
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 Colorectal 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 3 inclusion and 3 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 28 Aug 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?
Course of Antineoplastic Treatment (time frame: 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 NCT00910819, which also lists 2 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 28 Aug 2025.