Tumour Registry Colorectal Cancer (TKK)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by iOMEDICO AG
Sponsor:
Collaborators:
Arbeitskreis Klinische Studien
Arbeitsgemeinschaft fur Internistische Onkologie
Information provided by (Responsible Party):
iOMEDICO AG
ClinicalTrials.gov Identifier:
NCT00910819
First received: May 28, 2009
Last updated: June 27, 2016
Last verified: June 2016
  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 ] [ Designated as safety issue: No ]

Estimated 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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910819

Contacts
Contact: Natalie Wetzel +49 761 15242 - 0 info@iomedico.com
Contact: Martina Jänicke, PhD +49 761 15242 - 0 info@iomedico.com

Locations
Germany
iOMEDICO AG Recruiting
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 
Study First Received: May 28, 2009
Last Updated: June 27, 2016
Health Authority: Germany: Ethics Commission
Individual Participant Data  
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

ClinicalTrials.gov processed this record on August 22, 2016