Methylated Genes in Blood as Biomarkers for Advanced Lung Cancer

This study has been completed.
Sponsor:
Collaborators:
University of Southern California
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00579462
First received: December 19, 2007
Last updated: November 30, 2010
Last verified: November 2010
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Methylated Genes in Blood as Biomarkers for Advanced Lung Cancer

Resource links provided by NLM:


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

Whole Blood


Enrollment: 281
Study Start Date: January 2003
Study Completion Date: November 2010
Primary Completion Date: November 2010 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
University of Southern California
Investigators
Principal Investigator: Christopher Azzoli, M.D. Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Christopher Azzoli, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00579462     History of Changes
Other Study ID Numbers: 02-111
Study First Received: December 19, 2007
Last Updated: November 30, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Stage III or IV Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014