Lung CancerNCT01192919
Tumour Registry Lung Cancer (TLK)
An observational study of Lung Cancer, run by iOMEDICO AG.
Trial summary
Overview of treatment reality in patients with bronchial carcinoma requiring systemic treatment and being treated by office-based oncologists in Germany. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 2,500 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jul 2016
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with lung cancer requiring therapy
Who may be able to join
- 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
Who cannot join
- patients not receiving any systemic therapy
About this study
Official title: Clinical Registry Describing Treatment Reality and Therapy Modalities of Patients With Lung Cancer (NSCLC, SCLC and Neuroendocrine Tumors) Requiring Therapy.
Overview of treatment reality in patients with bronchial carcinoma requiring systemic treatment and being treated by office-based oncologists in Germany.
Read the 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.
- Conditions
- Lung Cancer
- Keywords
- bronchial carcinoma, registry, real life treatment, cohort study, NSCLC, SCLC, Germany
- Medical subject headings
- Lung Neoplasms, Carcinoma, Bronchogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with lung cancer | Patients with lung cancer requiring therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation of actually used therapy forms in bronchial carcinoma requiring treatment
Measured: 3 years per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by iOMEDICO AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hans-Werner Tessen, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192919
- Sponsor's protocol ID
- IOM TLK
- Status last verified
- Feb 2020
- First submitted
- 30 Aug 2010
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28916198Steffens CC, Elender C, Hutzschenreuter U, Dille S, Binninger A, Spring L, Janicke 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 - Results from the prospective German TLK cohort study. Lung Cancer. 2019 Apr;130:216-225. doi: 10.1016/j.lungcan.2019.02.026. Epub 2019 Feb 25.
PubMed 30885347
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Registry Describing Treatment Reality and Therapy Modalities of Patients With Lung Cancer (NSCLC, SCLC and Neuroendocrine Tumors) Requiring Therapy.
- ClinicalTrials.gov ID
- NCT01192919
- Acronym / sponsor ID
- IOM TLK
- Conditions
- Lung Cancer
- Keywords
- bronchial carcinoma, registry, real life treatment, cohort study, NSCLC, SCLC, Germany
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 1 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with lung cancer | – | –Patients with lung cancer requiring therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with lung cancer requiring therapy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- patients not receiving any systemic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Documentation of actually used therapy forms in bronchial carcinoma requiring treatment
Time frame: 3 years per patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Results publication: PubMed 28916198von 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.
- Results publication: PubMed 30885347Steffens CC, Elender C, Hutzschenreuter U, Dille S, Binninger A, Spring L, Janicke 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 - Results from the prospective German TLK cohort study. Lung Cancer. 2019 Apr;130:216-225. doi: 10.1016/j.lungcan.2019.02.026. Epub 2019 Feb 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans-Werner Tessen, MD principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by iOMEDICO AG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Documentation of actually used therapy forms in bronchial carcinoma requiring treatment (time frame: 3 years per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01192919, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020.