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Detection of Occult Micrometastases in Patients With Clinical Stage I NSCLC: A Prospective Analysis
RATIONALE: Detecting very early metastases in bone marrow and/or lymph nodes may help doctors plan better treatment for non-small cell lung cancer. PURPOSE: Clinical trial to detect the presence of metastatic cancer in patients with stage I non-small cell lung cancer that has not been previously treated.
OBJECTIVES: * Determine whether the presence of occult micrometastases (OM) detected by immunohistochemistry or reverse transcriptase-polymerase chain reaction (RT-PCR) in histologically negative lymph nodes or bone marrow is associated with poorer survival among patients with stage I non-small cell lung cancer. * Determine the incidence of OM in histologically negative lymph nodes and bone marrow by immunohistochemistry (staining for cytokeratins and the CEA glycoprotein) or RT-PCR (to detect CEA mRNA) in these patients. * Assess the sensitivity of immunohistochemistry relative to RT-PCR for detecting OM in these patients. * Determine the relationship between tumor size (or T-stage) and the presence of OM detected by immunohistochemistry or RT-PCR in these patients. * Determine the relationship between the presence of OM and disease-free survival in these patients. * Determine the relationship between the site of OM and incidence of recurrence, site of recurrence, and survival of these patients. OUTLINE: At the time of thoracotomy and pulmonary resection, patients have samples of bone marrow, primary tumor, and intrathoracic lymph nodes harvested. The presence of occult metastases in bone marrow and lymph nodes is assessed using immunohistochemistry or reverse transcriptase-polymerase chain reaction. Patients are followed every 6 months for 5 years.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
University of Minnesota Medical School
Minneapolis, Minnesota, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Start Date
May 1, 1997
Primary Completion Date
March 1, 2002
Completion Date
June 1, 2010
Last Updated
June 29, 2016
501
ACTUAL participants
reverse transcriptase-polymerase chain reaction
GENETIC
immunohistochemistry staining method
OTHER
Lead Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
NCT05692635
NCT05198830
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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