DNA Chip Based Prognosis of Lung Cancer

This study has been completed.
Information provided by (Responsible Party):
Medical Prognosis Institute A/S
ClinicalTrials.gov Identifier:
First received: September 8, 2009
Last updated: September 22, 2015
Last verified: September 2015
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).

Carcinoma, Non-Small-Cell Lung

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: DNA Chip Based Prognosis of Lung Cancer

Resource links provided by NLM:

Further study details as provided by Medical Prognosis Institute A/S:

Primary Outcome Measures:
  • Disease-related survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
post resection specimen

Enrollment: 144
Study Start Date: June 2008
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973427

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
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
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

No publications provided

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
Study First Received: September 8, 2009
Last Updated: September 22, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Medical Prognosis Institute A/S:

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

ClinicalTrials.gov processed this record on November 24, 2015