- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00973427
DNA Chip Based Prognosis of Lung Cancer
September 22, 2015 updated by: Medical Prognosis Institute A/S
The purpose of the study is to determine whether a DNA chip, designed by Medical Prognosis Institute (MPI), can provide an accurate prognosis for survival of NSCLC (adeno-, squamous and large cell lung cancer).
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
144
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aarhus, Denmark, 8200
- Aarhus University Hospital
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Copenhagen, Denmark, 2100
- University of Copenhagen
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Odense, Denmark, 5000
- Odense University Hospital
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama
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New York
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
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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 to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The population consist of subjects being examined for NSCLC at Roswell Park Cancer Institute (US), University of Alabama (US), Copenhagen University (DK), Odense University Hospital (DK) and Aarhus University Hospital (DK)
Description
Inclusion Criteria:
- A histological diagnosis of primary NSCLC stage Ia
- Surgical removal of the tumor
- Age between 18 and 75 years
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- A primary NSCLC stage Ia diagnosis that is changed to not primary NSCLC or NSCLC stage Ib-IV after surgery.
- Adjuvant treatment with chemotherapy.
- Prior history of cancer in the past 5 years or breast cancer at any time.
- Life expectancy less than 3 years in the opinion of the investigator due to concurrent illnesses.
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease-related survival
Time Frame: 5 years
|
5 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to progression
Time Frame: 5 years
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5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Steen Knudsen, PhD, Medical Prognosis Institute (MPI)
- Study Director: Jens B. Sørensen, MD, Dept. Oncology, Copenhagen University
- Study Director: Jesper Ravn, MD, University of Copenhagen
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
June 1, 2008
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
September 8, 2009
First Submitted That Met QC Criteria
September 8, 2009
First Posted (Estimate)
September 9, 2009
Study Record Updates
Last Update Posted (Estimate)
September 23, 2015
Last Update Submitted That Met QC Criteria
September 22, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MPI-1001
- H-B-2007-099
- WIRB Protocol #20080904
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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