Prevention of Tumor Spread Due to Lung Cancer Surgery
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      This study will investigate operative techniques to reduce the risk of tumor spread as a
      result of lung cancer surgery. Recent studies indicate that tumor cells may be released into
      the bloodstream due to handling of the lung during surgery, causing disease spread in
      patients whose tumor was previously confined to the lung. This study will examine whether the
      order in which the pulmonary vein (a vessel carrying blood from the lungs to the heart) and
      artery (vessel carrying blood from the heart to the lungs) are tied off during surgery
      affects the risk of tumor spread and disease recurrence.

      Patients 18 years of age or older with operable Stage I or Stage II non-small cell lung
      cancer and no evidence of tumor spread beyond the lung may be eligible for this study.
      Candidates will be screened with a medical history, blood tests, chest X-ray, and possibly
      mediastinal evaluation. This test involves inserting a tube into the chest cavity to look for
      signs of disease spread beyond the lung.

      All participants will undergo standard surgery for lung cancer. During the procedure, both
      the pulmonary artery and pulmonary vein are tied off; for this study, patients will be
      randomly assigned to have either the artery or the vein ligated first. Patients will be
      followed every 6 months for two years with blood tests and X-rays to look for disease
      recurrence.

      ...
    

Detailed description: 
      The VALID study is designed to obtain information regarding factors associated with the risk
      of recurrence after resection of early stage Non-Small Cell Lung Cancer (NSCLC). Until
      recently, the only clearly identified prognostic factor was the stage of the disease. Recent
      development of sensitive molecular assays has provided a way to study the effect of
      circulating tumor cells on clinical outcome. Preliminary studies have shown that tumor cells
      detected by such means in lymph nodes or in bone marrow are associated with an increased risk
      of recurrence. Preliminary studies have also indicated that the level of circulating tumor
      cells in the blood stream is effected by intraoperative factors, i.e. the sequence of vessel
      ligation.

      The main objective for this study is to investigate the influence of intraoperative sequence
      of vessel ligation and how this affects tumor recurrence and survival. In addition, we will
      also investigate the use of molecular assays to detect circulating tumor cells as a surrogate
      endpoint for the occurrence of distant metastases and/or death after surgery for NSCL.
      Several of these molecular markers have proven their value in case series but have not been
      rigorously tested for association with the clinical endpoints of interest, tumor recurrence
      and survival. We believe that this study may lead to important answers about how the spread
      of tumor cells occurs and if novel detection methods can be used to predict patient outcome.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients 18 or older with Stage I or II non-small cell lung cancer and no evidence of tumor
        spread beyond the lung.
      
Keywords: Cancer; Lung Cancer; Surgical Resection; Non-Small Cell Lung Cancer; NSCLC