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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01192919
Other study ID # IOM TLK
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2010
Est. completion date July 2016

Study information

Verified date February 2020
Source iOMEDICO AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Overview of treatment reality in patients with bronchial carcinoma requiring systemic treatment and being treated by office-based oncologists in Germany.


Description:

The TLK is a prospective, longitudinal, nation wide cohort study that collects data on the treatment reality of patients with NSCLC and SCLC. 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. Patients are followed until death or for a maximum of 3 years.


Recruitment information / eligibility

Status Completed
Enrollment 2500
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- histologically confirmed Small Cell Lung Cancer (SCLC), Non Small Lung Cancer (NSCLC) or neuroendocrine tumors receiving therapy

- written informed consent

- start of neoadjuvant, adjuvant or first-line therapy no longer than 4 weeks before informed consent

Exclusion Criteria:

- patients not receiving any systemic therapy

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
iOMEDICO AG

References & Publications (2)

Steffens CC, Elender C, Hutzschenreuter U, Dille S, Binninger A, Spring L, Jänicke M, Marschner N; TLK-Group (Tumour Registry Lung Cancer). Treatment and outcome of 432 patients with extensive-stage small cell lung cancer in first, second and third line - — View Citation

von Verschuer U, Schnell R, Tessen HW, Eggert J, Binninger A, Spring L, Jänicke M, Marschner N; TLK-Group (Tumour Registry Lung Cancer). Treatment, outcome and quality of life of 1239 patients with advanced non-small cell lung cancer - final results from — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Documentation of actually used therapy forms in bronchial carcinoma requiring treatment 3 years per patient
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