Detection of Occult Micrometastases in Patients With Clinical Stage I NSCLC: A Prosepective Analysis
- 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
- 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
- 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.
PROJECTED ACCRUAL: Approximately 500 patients will be accrued for this study within 3-3.5
Primary Purpose: Diagnostic
Michael A. Maddaus, MD
Masonic Cancer Center, University of Minnesota
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|
|Lineberger Comprehensive Cancer Center, UNC||Chapel Hill, North Carolina 27599-7295|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Marlene & Stewart Greenebaum Cancer Center, University of Maryland||Baltimore, Maryland 21201|
|Ellis Fischel Cancer Center - Columbia||Columbia, Missouri 65203|
|Barnes-Jewish Hospital||Saint Louis, Missouri 63110|
|State University of New York - Upstate Medical University||Syracuse, New York 13210|
|Holden Comprehensive Cancer Center at The University of Iowa||Iowa City, Iowa 52242-1009|
|University of Minnesota Medical School||Minneapolis, Minnesota 55455|