Tumour Registry Lung Cancer (TLK)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
iOMEDICO AG
ClinicalTrials.gov Identifier:
NCT01192919
First received: August 30, 2010
Last updated: June 27, 2016
Last verified: February 2016
  Purpose
Overview of treatment reality in patients with bronchial carcinoma requiring systemic treatment and being treated by office-based oncologists in Germany.

Condition
Lung Cancer

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by iOMEDICO AG:

Primary Outcome Measures:
  • Documentation of actually used therapy forms in bronchial carcinoma requiring treatment [ Time Frame: 3 years per patient ] [ Designated as safety issue: No ]

Estimated Enrollment: 2500
Study Start Date: January 2010
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with lung cancer
Patients with lung cancer requiring therapy

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.
  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
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
  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: NCT01192919

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

Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT01192919     History of Changes
Other Study ID Numbers: IOM TLK 
Study First Received: August 30, 2010
Last Updated: June 27, 2016
Health Authority: Germany: Ethics Commission
Individual Participant Data  
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

ClinicalTrials.gov processed this record on July 25, 2016