NCT00003006

Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer

Detection of Occult Micrometastases in Patients With Clinical Stage I NSCLC: A Prospective Analysis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 501 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
GENETIC	reverse transcriptase-polymerase chain reaction
OTHER	immunohistochemistry staining method

Timeline

• Start date: 1997-05-01
• Primary completion: 2002-03-01
• Completion: 2010-06-01
• First posted: 2003-08-13
• Last updated: 2016-06-29

Locations

10 sites across 1 country: United States