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Tumour Registry Lung Cancer (TLK)

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ClinicalTrials.gov Identifier: NCT01192919
Recruitment Status : Completed
First Posted : September 1, 2010
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
iOMEDICO AG

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

Condition or disease
Lung Cancer

Detailed 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.

Study Type : Observational
Actual Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Registry Describing Treatment Reality and Therapy Modalities of Patients With Lung Cancer (NSCLC, SCLC and Neuroendocrine Tumors) Requiring Therapy.
Study Start Date : January 2010
Primary Completion Date : July 2016
Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Group/Cohort
Patients with lung cancer
Patients with lung cancer requiring therapy



Primary Outcome Measures :
  1. Documentation of actually used therapy forms in bronchial carcinoma requiring treatment [ Time Frame: 3 years per patient ]


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
patients with lung cancer requiring therapy
Criteria

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

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): NCT01192919


Sponsors and Collaborators
iOMEDICO AG
Investigators
Principal Investigator: Hans-Werner Tessen, MD

Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT01192919     History of Changes
Other Study ID Numbers: IOM TLK
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by iOMEDICO AG:
bronchial carcinoma
registry
real life treatment
cohort study
NSCLC
SCLC
Germany

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases