Expired Study
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New York, New York 10065


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.


Study summary:

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.


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


Study is Available At:


Original ID:

02-111


NCT ID:

NCT00579462


Secondary ID:


Study Acronym:


Brief Title:

Methylated Genes in Blood as Biomarkers for Advanced Lung Cancer


Official Title:

Methylated Genes in Blood as Biomarkers for Advanced Lung Cancer


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Memorial Sloan-Kettering Cancer Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspecti


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

281


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:January 2003
Completion Date:November 2010
Completion Type:Actual
Primary Completion Date:November 2010
Primary Completion Type:Actual
Verification Date:November 2010
Last Changed Date:November 30, 2010
First Received Date:December 19, 2007

Study Outcomes

Outcome Type:Secondary Outcome
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.
Time Frame:1 year
Safety Issues:False
Outcome Type:Primary 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.
Time Frame:1 year
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:Blood and Tissue studies
Description: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.
Arm Name:1

Study Arms

Study Arm Type:Other
Arm Name:1
Description:Patients with advanced lung cancer.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan-Kettering Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Samples and Retentions

Sample Retention:Samples With DNA
Description: Whole Blood
Study Population: Patients being seen in Thoracic Oncology Clinic
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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