- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02613637
Registry Study on Biological Disease Profile and Clinical Outcome in Patients With Newly Diagnosed or Existent Lung Cancer The LuCa Biology and Outcome (BiO)-Project
February 22, 2017 updated by: Lars Bullinger, University of Ulm
Registry Study on Biological Disease Profile and Clinical Outcome in Patients with Newly Diagnosed or Existent Lung Cancer
The LuCa Biology and Outcome (BiO)-Project
Study Overview
Study Type
Observational
Enrollment (Anticipated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lars Bullinger, MD
- Phone Number: +4973150045900
- Email: Lars.Bullinger@uniklinik-ulm.de
Study Contact Backup
- Name: Gerlinde Schmidtke-Schrezenmeier, MD
Study Locations
-
-
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Esslingen, Germany
- Recruiting
- Klinikum Esslingen GmbH
-
Stuttgart, Germany
- Recruiting
- Pneumologie, Internistische Intensivmedizin, Beatmungsmedizin und Allgemeine Innere Medizin, Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH
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Ulm, Germany
- Recruiting
- Universitätsklinikum Ulm
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All patients with newly diagnosed or existent lung cancer of all LuCa BiO centers in Germany are intended to be registered with in the LuCa BiO Registry.
Description
Inclusion Criteria:
- Patients with suspected diagnosis of lung cancer, or previously diagnosed lung cancer
- Age ≥ 18 years. There is no upper age limit.
Exclusion Criteria:
- Severe neurological or psychiatric disorder interfering with ability to give an informed consent
- No consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician about study participation
- No consent for biobanking of patient's biological specimens and performance of analyses on stored material.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival
Time Frame: maximally 10 years
|
maximally 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lars Bullinger, MD, University Hospital of Ulm
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
June 22, 2015
First Submitted That Met QC Criteria
November 23, 2015
First Posted (Estimate)
November 24, 2015
Study Record Updates
Last Update Posted (Actual)
February 24, 2017
Last Update Submitted That Met QC Criteria
February 22, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LuCa BiO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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