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DNA Chip Based Prognosis of Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00973427
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

Condition or disease
Carcinoma, Non-Small-Cell Lung

Study Design

Study Type : Observational
Actual Enrollment : 144 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DNA Chip Based Prognosis of Lung Cancer
Study Start Date : June 2008
Primary Completion Date : September 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Disease-related survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Time to progression [ Time Frame: 5 years ]

Biospecimen Retention:   Samples Without DNA
post resection specimen

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

Inclusion Criteria:

  1. A histological diagnosis of primary NSCLC stage Ia
  2. Surgical removal of the tumor
  3. Age between 18 and 75 years
  4. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. A primary NSCLC stage Ia diagnosis that is changed to not primary NSCLC or NSCLC stage Ib-IV after surgery.
  2. Adjuvant treatment with chemotherapy.
  3. Prior history of cancer in the past 5 years or breast cancer at any time.
  4. Life expectancy less than 3 years in the opinion of the investigator due to concurrent illnesses.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00973427


Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8200
University of Copenhagen
Copenhagen, Denmark, 2100
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Medical Prognosis Institute A/S
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
More Information

Responsible Party: Medical Prognosis Institute A/S
ClinicalTrials.gov Identifier: NCT00973427     History of Changes
Other Study ID Numbers: MPI-1001
H-B-2007-099
WIRB Protocol #20080904
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by Medical Prognosis Institute A/S:
NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases