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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00003006

Enrollment

501

Registered

2003-08-13

Start date

1997-05-31

Completion date

2010-06-30

Last updated

2016-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer

Brief 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.

Interventions

GENETICreverse transcriptase-polymerase chain reaction

OTHERimmunohistochemistry staining method

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Clinical stage I proven or suspected new non-small cell lung carcinoma T1 or T2 primary N1 or N2 lymph nodes \<1cm on CT or negative mediastinoscopy * ≥ 5 years since prior chemo or XRT; no prior mediastinal or chest XRT. * ≥ 18 years of age * No history of previous lung cancer or concomitant malignancy

Design outcomes

Primary

Measure	Time frame
overall survival	up to 5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026