Tumour Registry Breast Cancer | NCT01351584

Studies
Tumour Registry Breast Cancer

NCT01351584

Sponsor

iOMEDICO AG

Status

Completed

Last Update Posted

Aug 28, 2025Actual

Enrollment

4,500Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

Not provided

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

ID	Type	Description	Link
Tumorregister Mammakarzinom	Other Identifier	iOMEDICO AG

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

Feb 2007Actual

Primary Completion Date

Dec 2021Actual

Completion Date

Dec 2021Actual

First Submitted Date

May 9, 2011

First Submission Date that Met QC Criteria

May 9, 2011

First Posted Date

May 11, 2011Estimated

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

The registry aims to collect and analyse information on the antineoplastic treatment of breast cancer in daily routine practice of office-based and clinic-based medical oncologists in Germany.

Detailed Description

The TMK is a prospective, longitudinal, nation wide cohort study with the purpose to record information on the antineoplastic treatment of breast 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 (MaNut) and physical activity (MaNut) on the course of the adjuvant disease will be examined, as well as long-term effects of adjuvant treatment (MaTox) and the multiple patient-reported outcomes (MaLife).

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

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,500Actual

Measure	Description	Time Frame
Course of Antineoplastic Treatment		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Breast cancer
18 years and older
Antineoplastic or antihormonal treatment

Exclusion Criteria:

No breast cancer
Below 18 years
No antineoplastic or antihormonal treatment

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Breast cancer patients undergoing antineoplastic or antihormonal therapy.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Hans Tesch, MD		Study Chair

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28586735	Background	Fietz T, Tesch H, Rauh J, Boller E, Kruggel L, Janicke M, Marschner N; TMK-Group (Tumour Registry Breast Cancer). Palliative systemic therapy and overall survival of 1,395 patients with advanced breast cancer - Results from the prospective German TMK cohort study. Breast. 2017 Aug;34:122-130. doi: 10.1016/j.breast.2017.05.014. Epub 2017 Jun 3.
28494404

ID	Term
D001943	Breast Neoplasms
D009043	Motor Activity

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases