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DNA Chip Based Prognosis of Lung Cancer

This study is currently recruiting participants.
Verified June 2011 by Medical Prognosis Institute A/S
Sponsor:
Information provided by:
Medical Prognosis Institute A/S
ClinicalTrials.gov Identifier:
NCT00973427
First received: September 8, 2009
Last updated: June 8, 2011
Last verified: June 2011
History of Changes
  Purpose

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
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:

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

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

Biospecimen Retention:   Samples Without DNA

post resection specimen


Estimated Enrollment: 135
Study Start Date: June 2008
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

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)

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

Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294
Contact: Robert Cerfolio, MD     205-934-5937     robert.cerfolio@ccc.uab.edu    
Contact: Ayesha Bryant, MD     205-996-9758     Ayesha.Bryant@ccc.uab.edu    
Principal Investigator: Robert Cerfolio, MD            
Sub-Investigator: Ayesha Bryant, MD            
Sub-Investigator: Douglas Minnich, MD            
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Sai Yendamuri, MD     716-239-0532     Sai.Yendamuri@Roswellpark.org    
Contact: Askia Dozier, BS, MS     716-845-3114     Askia.Dozier@Roswellpark.org    
Principal Investigator: Sai Yendamuri, MD            
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Hans Pilegaard, MD     +45 8949 5403     hanspile@rm.dk    
Sub-Investigator: Hans Pilegaard, MD            
Sub-Investigator: Niels Katballe, MD            
University of Copenhagen Recruiting
Copenhagen, Denmark, 2100
Contact: Jesper Ravn, MD     +45 3545 1173     jesper.ravn@rh.regionh.dk    
Principal Investigator: Jesper Ravn, MD            
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Erik Jakobsen, MD     +45 6541 3370     erik.jakobsen@ouh.regionsyddanmark.dk    
Principal Investigator: Erik Jakobsen, MD            
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

No publications provided

Responsible Party: Steen Knudsen, PhD, CSO, Medical Prognosis Institute (MPI)
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: June 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Medical Prognosis Institute A/S:
NSCLC

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

ClinicalTrials.gov processed this record on May 16, 2013