NCT00973427

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

6.3 years

First QC Date

September 8, 2009

Last Update Submit

September 22, 2015

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

NSCLC

Outcome Measures

Primary Outcomes (1)

  • Disease-related survival

    5 years

Secondary Outcomes (1)

  • Time to progression

    5 years

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

University of Copenhagen

Copenhagen, 2100, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

post resection specimen

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Steen Knudsen, PhD

    Medical Prognosis Institute (MPI)

    STUDY CHAIR

  • Jens B. Sørensen, MD

    Dept. Oncology, Copenhagen University

    STUDY DIRECTOR

  • Jesper Ravn, MD

    University of Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2009

First Posted

September 9, 2009

Study Start

June 1, 2008

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

US(2)DK(3)