Non-Small Cell Lung CancerNCT00341380
Prevention of Tumor Spread Due to Lung Cancer Surgery
An observational study of Non-Small Cell Lung Cancer, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2002to 17 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina
About this study
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
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.
Read more
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.
...
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Cancer, Lung Cancer, Surgical Resection, Non-Small Cell Lung Cancer, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Undergoing resection of lung tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the effect of initial venous versus arterial ligation during resection for NSCLC on the risk of distant metastases within two years of follow-up
Risk of metastases recurrence after tumor resection
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start24 Sep 2002
- Primary completion13 Apr 2007
- Study completion17 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Investigators
- Jack Taylor, M.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341380
- Sponsor's protocol ID
- 999902319
- Other IDs
- 02-E-N319
- Status last verified
- Jan 2020
- First submitted
- 19 Jun 2006
- Last updated
- 6 Jan 2020
- Results posted
- No
Publications
Hansen E, Wolff N, Knuechel R, Ruschoff J, Hofstaedter F, Taeger K. Tumor cells in blood shed from the surgical field. Arch Surg. 1995 Apr;130(4):387-93. doi: 10.1001/archsurg.1995.01430040049007.
PubMed 7710337Kurusu Y, Yamashita J, Hayashi N, Mita S, Fujino N, Ogawa M. The sequence of vessel ligation affects tumor release into the circulation. J Thorac Cardiovasc Surg. 1998 Jul;116(1):107-13. doi: 10.1016/s0022-5223(98)70248-x.
PubMed 9671904Pantel K, Izbicki J, Passlick B, Angstwurm M, Haussinger K, Thetter O, Riethmuller G. Frequency and prognostic significance of isolated tumour cells in bone marrow of patients with non-small-cell lung cancer without overt metastases. Lancet. 1996 Mar 9;347(9002):649-53. doi: 10.1016/s0140-6736(96)91203-9.
PubMed 8596379
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00341380
- Acronym / sponsor ID
- 999902319
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Cancer, Lung Cancer, Surgical Resection, Non-Small Cell Lung Cancer, NSCLC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 24 Sep 2002
- Primary completion
- 13 Apr 2007 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Undergoing resection of lung tumor |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the effect of initial venous versus arterial ligation during resection for NSCLC on the risk of distant metastases within two years of follow-up
Time frame: 2 years
Risk of metastases recurrence after tumor resection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Background: PubMed 7710337Hansen E, Wolff N, Knuechel R, Ruschoff J, Hofstaedter F, Taeger K. Tumor cells in blood shed from the surgical field. Arch Surg. 1995 Apr;130(4):387-93. doi: 10.1001/archsurg.1995.01430040049007.
- Background: PubMed 9671904Kurusu Y, Yamashita J, Hayashi N, Mita S, Fujino N, Ogawa M. The sequence of vessel ligation affects tumor release into the circulation. J Thorac Cardiovasc Surg. 1998 Jul;116(1):107-13. doi: 10.1016/s0022-5223(98)70248-x.
- Background: PubMed 8596379Pantel K, Izbicki J, Passlick B, Angstwurm M, Haussinger K, Thetter O, Riethmuller G. Frequency and prognostic significance of isolated tumour cells in bone marrow of patients with non-small-cell lung cancer without overt metastases. Lancet. 1996 Mar 9;347(9002):649-53. doi: 10.1016/s0140-6736(96)91203-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack Taylor, M.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the effect of initial venous versus arterial ligation during resection for NSCLC on the risk of distant metastases within two years of follow-up (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00341380, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.