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Completed

NCT Number: NCT00003006

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

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.

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Holden Comprehensive Cancer Center at The University of Iowa, Iowa City, Iowa, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

reverse transcriptase-polymerase chain reaction

Genetic

immunohistochemistry staining method

Other

Primary outcomes

  1. overall survival

    Time frame: up to 5 years

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
1997
Primary completion
2002
Study completion
2010
First posted
Aug 13, 2003
Registry last updated
Jun 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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