Clinical trial NCT00579462: Methylated Genes in Blood as Biomarkers for Advanced Lung Cancer
Official title: Methylated Genes in Blood as Biomarkers for Advanced Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Stage III or IV Lung Cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Southern California
First posted: 2007-12-24
Enrollment: 281
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being seen in Thoracic Oncology Clinic

Brief 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.

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 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

Primary outcomes:
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.
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Christopher Azzoli, M.D.
role: PRINCIPAL_INVESTIGATOR
References: