Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341380
Status:
COMPLETED
Last Update Posted:
2020-01-06
First Post:
2006-06-19
Brief Title:
Prevention of Tumor Spread Due to Lung Cancer Surgery
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Venous or Arterial Ligation and Intraoperative Dissemination VALID of Cancer Cells A Randomized Clinical Trial For Patients With Resectable Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 ie 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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-E-N319 | None | None | None |