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Tumour Registry Colorectal Cancer (TKK)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00910819
First Posted: June 1, 2009
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Arbeitskreis Klinische Studien
Arbeitsgemeinschaft fur Internistische Onkologie
Information provided by (Responsible Party):
iOMEDICO AG
  Purpose
To describe treatment reality of patients with colorectal cancer treated by office-based and clinic-based medical oncologists in Germany.

Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective and Retrospective Observation of the Adjuvant and Palliative Treatment Strategies in the Therapy of Colorectal Cancer in Germany

Resource links provided by NLM:


Further study details as provided by iOMEDICO AG:

Primary Outcome Measures:
  • Course of Antineoplastic Treatment [ Time Frame: 5 years ]

Enrollment: 6500
Study Start Date: September 2006
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Colorectal cancer patients undergoing antineoplastic treatment.
Criteria

Inclusion Criteria:

  • Colorectal cancer
  • 18 years and older
  • Antineoplastic treatment

Exclusion Criteria:

  • No colorectal cancer
  • Below 18 years
  • No antineoplastic treatment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910819


Locations
Germany
iOMEDICO AG
Freiburg, BW, Germany, 79108
Sponsors and Collaborators
iOMEDICO AG
Arbeitskreis Klinische Studien
Arbeitsgemeinschaft fur Internistische Onkologie
Investigators
Study Chair: Roland Schnell, MD
  More Information

Publications:
Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT00910819     History of Changes
Other Study ID Numbers: IOM TKK
First Submitted: May 28, 2009
First Posted: June 1, 2009
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by iOMEDICO AG:
Colorectal Cancer
Advanced Colorectal Cancer
Epidemiology
Health Services Research
Germany
Registry
Palliative Care
Palliative Treatment
Adjuvant Drug Therapy
Nutrition Assessment
Physical Activity

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases