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Venous or Arterial Ligation and Intraoperative Dissemination (VALID) of Cancer Cells: A Randomized Clinical Trial For Patients With Resectable Non-Small Cell Lung Cancer

Phase 2
19 Years
Not Enrolling
Lung Cancer, Non-Small Cell Lung Cancer

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Trial Information

Venous or Arterial Ligation and Intraoperative Dissemination (VALID) of Cancer Cells: A Randomized Clinical Trial For Patients With Resectable Non-Small Cell Lung Cancer

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.

Inclusion Criteria


Patients for this study will be identified through the Multidisciplinary Thoracic Oncology
Clinic at UNC. Enrollment criteria for the study are: 1) Surgically respectable Stage I
or II non-small cell lung carcinoma; 2) Negative mediastinal evaluation; 3) No
contraindications for surgery; and 4) More than 18 years of age.


Patients with prior carcinoma within 5 years (except basal cell carcinoma of the skin and
superficial bladder cancer) will be excluded from the study. Patients who are enrolled
based on clinical Stage I or II but are revised to higher Stage once the surgical
specimens are examined will be excluded from statistical analysis.

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Presence of one or more distant metastases at 2 years after the resection of the tumor.

Principal Investigator

Jack Taylor, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute of Environmental Health Sciences (NIEHS)


United States: Federal Government

Study ID:




Start Date:

September 2002

Completion Date:

April 2007

Related Keywords:

  • Lung Cancer
  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • Tumor Marker
  • Gene Expression
  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of North Carolina at Chapel HillChapel Hill, North Carolina  27599