Methylated Genes in Blood as Biomarkers for Advanced Lung Cancer

NCT00579462 | Completed

• 1 other identifier: 02-111
• Study Type: observational
• Target: 281
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Stage III or IV Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• 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.

  1 year

Study Arms (1)

1

Patients with advanced lung cancer.

Other: Blood and Tissue studies

Interventions

Blood and Tissue studies OTHER

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.

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients being seen in Thoracic Oncology Clinic

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• University of Southern California: collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Christopher Azzoli, M.D.

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 24, 2007
• Study Start: January 1, 2003
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 1, 2010

Record last verified: 2010-11

Locations

US (1)