Methylated Genes in Blood as Biomarkers for Advanced Lung Cancer

Lung Cancer Clinical Trial

Official title:

Methylated Genes in Blood as Biomarkers for Advanced Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00579462
• Other study ID #: 02-111
• Status: Completed
• Phase: N/A
• First received: December 19, 2007
• Last updated: November 30, 2010
• Start date: January 2003
• Est. completion date: November 2010

Study information

• Verified date: November 2010
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to study whether the presence of lung cancer in your body can be detected by testing the blood, and if the results of these blood tests change as your tumor shrinks or grows.

Description:

This is a cooperative research project involving patients on the Thoracic Oncology Service at Memorial Sloan-Kettering Cancer Center, and the laboratory of Dr. Peter Danenberg, Professor of Biochemistry and Molecular Biology, University of Southern California / Norris Comprehensive Cancer Center in Los Angeles, California. The primary objectives are to measure the proportion of patients with advanced (stage III-IV) lung cancer with methylated genes in their blood, and to determine if response to chemotherapy (complete or partial radiologic response) in patients with advanced lung cancer renders methylated genes undetectable in the blood. This research project will enroll approximately 80 patients per year over 4 years to generate a sample size of approximately 320 patients.Blood will be collected from participating patients at baseline, as close as possible to the date of their baseline radiologic assessment. Three follow-up blood collections will be drawn, each within 7-10 days of each follow-up radiologic evaluation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pathologically proven advanced (stage III-IV) lung cancer

• Measurable and/or evaluable disease

• Enrollment in an MSKCC protocol of experimental chemotherapy with radiologic response rate as an efficacy outcome variable, or prescription of standard chemotherapy in which the patient will be receiving routine radiological scans (every 4-8 weeks) as standard clinical practice.

• Signed written informed consent

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Blood and Tissue studies
Blood will be collected from participating patients at baseline, as close as possible to the date of their baseline radiologic assessment. Three follow-up blood collections will be drawn, each within 7-10 days of each follow-up radiologic evaluation.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI), University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure the proportion of patients with advanced (stage IIIB/IV) lung cancer with methylated genes in their blood and determine if response to chemotherapy (CR or PR radiologic response) renders methylated genes undetectable in blood.		1 year	No
Secondary	To collect data regarding time to disease progression in order to explore whether pretreatment and/or posttreatment blood levels of methylated genes are associated with an increased chance of disease progression.		1 year	No