Tumour Registry Lung Cancer (TLK) | NCT01192919

Studies
Tumour Registry Lung Cancer (TLK)

NCT01192919

Sponsor

iOMEDICO AG

Status

Completed

Last Update Posted

Mar 2, 2020Actual

Enrollment

2,500Actual

Phase

Not provided

Conditions

Lung 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

Status Module

Record Verification Date

Feb 2020

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

Jan 2010

Primary Completion Date

Jul 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Aug 30, 2010

First Submission Date that Met QC Criteria

Aug 31, 2010

First Posted Date

Sep 1, 2010Estimated

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

Feb 27, 2020

Last Update Posted Date

Mar 2, 2020Actual

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

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

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.

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

2,500Actual

Label	Type	Description	Intervention Names
Patients with lung cancer		Patients with lung cancer requiring therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Documentation of actually used therapy forms in bronchial carcinoma requiring treatment		3 years per patient

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

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

patients with lung cancer requiring therapy

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Hans-Werner Tessen, MD		Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28916198	Result	von Verschuer U, Schnell R, Tessen HW, Eggert J, Binninger A, Spring L, Janicke 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 the prospective German TLK cohort study. Lung Cancer. 2017 Oct;112:216-224. doi: 10.1016/j.lungcan.2017.07.031. Epub 2017 Sep 12.
30885347

ID	Term
D008175	Lung Neoplasms
D002283	Carcinoma, Bronchogenic

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms