DNA Chip Based Prognosis of Lung Cancer

NCT ID: NCT00973427

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

144 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2014-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Prognosis Institute A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steen Knudsen, PhD

Role: STUDY_CHAIR

Medical Prognosis Institute (MPI)

Jens B. Sørensen, MD

Role: STUDY_DIRECTOR

Dept. Oncology, Copenhagen University

Jesper Ravn, MD

Role: STUDY_DIRECTOR

University of Copenhagen

Locations

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University of Alabama

Birmingham, Alabama, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Aarhus University Hospital

Aarhus, , Denmark

Site Status

University of Copenhagen

Copenhagen, , Denmark

Site Status

Odense University Hospital

Odense, , Denmark

Site Status

Countries

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United States Denmark

Other Identifiers

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H-B-2007-099

Identifier Type: -

Identifier Source: secondary_id

WIRB Protocol #20080904

Identifier Type: -

Identifier Source: secondary_id

MPI-1001

Identifier Type: -

Identifier Source: org_study_id

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