Methylated Genes in Blood as Biomarkers for Advanced Lung Cancer - Full Text View

Purpose

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.

Condition	Intervention
Lung Cancer	Other: Blood and Tissue studies

MedlinePlus related topics:

Cancer Lung Cancer

ChemIDplus related topics:

BaseLine

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective

Official Title:	Methylated Genes in Blood as Biomarkers for Advanced Lung Cancer

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Whole Blood

Estimated Enrollment:	320
Study Start Date:	January 2003
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients with advanced lung cancer.	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.

Detailed 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients being seen in Thoracic Oncology Clinic

Criteria

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:

-None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579462

Contacts


Contact: Christopher Azzoli, M.D.		azzolic@mskcc.org

Locations


United States, New York
	Memorial Sloan-Kettering Cancer Center	Recruiting
	New York, New York, United States, 10065
	Contact: Christopher Azzoli, M.D.

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

University of Southern California

Investigators


Principal Investigator:	Christopher Azzoli, M.D.	Memorial Sloan-Kettering Cancer Center

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Christopher Azzoli )
Study ID Numbers:	02-111
First Received:	December 19, 2007
Last Updated:	June 5, 2008
ClinicalTrials.gov Identifier:	NCT00579462
Health Authority:	United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Stage III or IV Lung Cancer

Study placed in the following topic categories:

Thoracic Neoplasms

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) University of Southern California
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00579462