Tumour Registry Colorectal Cancer | NCT00910819

Studies
Tumour Registry Colorectal Cancer

NCT00910819

Sponsor

iOMEDICO AG

Status

Completed

Last Update Posted

Aug 28, 2025Actual

Enrollment

7,000Actual

Phase

Not provided

Conditions

Colorectal Cancer

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006Actual

Primary Completion Date

Mar 2022Actual

Completion Date

Mar 2022Actual

First Submitted Date

May 28, 2009

First Submission Date that Met QC Criteria

May 29, 2009

First Posted Date

Jun 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2025

Last Update Posted Date

Aug 28, 2025Actual

Name	Class
Arbeitskreis Klinische Studien	OTHER
Arbeitsgemeinschaft fur Internistische Onkologie	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

7,000Actual

Measure	Description	Time Frame
Course of Antineoplastic Treatment		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Colorectal cancer
18 years and older
Antineoplastic treatment

Exclusion Criteria:

No colorectal cancer
Below 18 years
No antineoplastic treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Colorectal cancer patients undergoing antineoplastic treatment.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roland Schnell, MD		Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
iOMEDICO AG		Freiburg im Breisgau	Baden-Wurttemberg	79108	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30834622	Background	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.
25945067

ID	Term
D015179	Colorectal Neoplasms
D009043	Motor Activity

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site