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Methylated Genes in Blood as Biomarkers for Advanced Lung Cancer


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Lung Cancer

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Trial Information

Methylated Genes in Blood as Biomarkers for Advanced Lung Cancer


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Christopher Azzoli, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

02-111

NCT ID:

NCT00579462

Start Date:

January 2003

Completion Date:

November 2010

Related Keywords:

  • Lung Cancer
  • Stage III or IV Lung Cancer
  • Lung Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021