DNA Chip Based Prognosis of Lung Cancer

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

DNA Chip Based Prognosis of Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973427
• Other study ID #: MPI-1001
• Secondary ID: H-B-2007-099WIRB
• Status: Completed
• Phase: N/A
• First received: September 8, 2009
• Last updated: September 22, 2015
• Start date: June 2008
• Est. completion date: September 2014

Study information

• Verified date: September 2015
• Source: Medical Prognosis Institute A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	University of Copenhagen	Copenhagen
Denmark	Odense University Hospital	Odense
United States	University of Alabama	Birmingham	Alabama
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medical Prognosis Institute A/S

Countries where clinical trial is conducted

United States,  Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-related survival		5 years	No
Secondary	Time to progression		5 years	No