Sequence of Vessel Interruption and Circulating Tumor Cells in Surgical Lung Cancer (CTC-01)

August 22, 2018 updated by: Massimo Conti, Laval University

Impact of the Sequence of Vessel Interruption During Major Pulmonary Resections for Non-small Cell Lung Cancer Based on Circulating Tumor Cells Detection Peroperatively in the Tumor-draining Pulmonary Vein: a Randomized Pilot Study.

This study aims to define the impact of the sequence of vessel interruption on change in CTC and CTC clusters density in the tumor-draining pulmonary vein between the period before surgical manipulation and before tumor-draining vein interruption.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
      • Québec, Canada, G1V 4G5
        • Institut universitaire de Cardiologie et de Pneumologie de Quebec
        • Contact:
        • Sub-Investigator:
          • Jérémy Tricard, MD
        • Sub-Investigator:
          • Rosaire Vaillancourt, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • NSCLC with preoperative pathological evidence,
  • Pure solid nodule or part-solid (>50%) ground glass nodule on CT scan
  • Clinical stage tumor-1 to 3, clinical stage node-0, clinical stage metastasis-0, (except clinical stage tumor-3 for chest wall, pericardium or phrenic nerve invasion)
  • Video-assisted thoracoscopic lobectomy or bi-lobectomy

Exclusion Criteria:

  • Pneumonectomy, segmentectomy, non anatomic resection
  • History of thoracic surgery on the same side
  • Necessity to perform a non-anatomic resection in addition to the lobectomy
  • No preoperative histological diagnosis
  • Pure ground glass nodule on CT scan
  • Clinical stage tumor-4 or 3 for chest wall, pericardium or phrenic nerve invasion
  • Clinical stage node ≥1
  • Neoadjuvant therapy
  • Second cancer or cancer in the past 5 years
  • First approach through thoracotomy with ribs spreading
  • Pregnancy, <18 years of age
  • Pulmonary adherences/symphysis found during surgery (impossible to perform the first blood sample without lung manipulation)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vein first
Tumor-draining pulmonary vein is interrupted first and before any surgical manipulation.
Procedure: Vein interruption before any other surgical manipulation

The pulmonary tumor-drainage vein is first exposed and punctured with a 23-gauge needle, and 7.5 ml of blood is drawn from the pulmonary vein prior to subsequent surgical manipulation for lobectomy. Collected blood is versed in a Cellsearch tube provided by the manufacturer (Menarini Silicon Biosystems, Castel Maggiore, Italy).

In the "vein first" group, the lobar vein is dissected and the cartridge and anvil of a vascular cartridge stapler are placed on either side of the vein. The vein is punctured above the stapler with a 23-gauge needle and 7.5 ml of blood is drawn. Finally, the vein is cut. The intervention then proceeds in the usual manner.
Active Comparator: Arteries before vein
Lobar arteries (+/- bronchus and inter-lobar fissures) are interrupted before tumor-draining pulmonary vein.
Procedure: Arteries interruption before vein interruption

The pulmonary tumor-drainage vein is first exposed and punctured with a 23-gauge needle, and 7.5 ml of blood is drawn from the pulmonary vein prior to subsequent surgical manipulation for lobectomy. Collected blood is versed in a Cellsearch tube provided by the manufacturer (Menarini Silicon Biosystems, Castel Maggiore, Italy).

In the "arteries before vein" group, lobar arteries are first dissected and interrupted (+/- the bronchus and inter-lobar fissures). The lobar vein is then dissected and blood sample is performed as described above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in CTC density
Time Frame: Within 96 hours after surgery
Changes in CTC count in 7.5 ml of blood sampled from the tumor-draining vein between the period before surgical manipulation (first sample) and before tumor-draining vein interruption (second sample).
Within 96 hours after surgery
Changes in CTC clusters density
Time Frame: Within 96 hours after surgery
Changes in CTC clusters (or CTC micro-emboli defined as ≥3 contiguous CTC) count in 7.5 ml of blood sampled from the tumor-draining vein between the period before surgical manipulation (first sample) and before tumor-draining vein interruption (second sample).
Within 96 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: 2 years and 5 years after surgery
Disease free survival 2 years and 5 years after surgery and recurrence site (local or distant metastasis).
2 years and 5 years after surgery
Overall survival
Time Frame: 2 years and 5 years after surgery
Overall survival 2 years and 5 years after surgery.
2 years and 5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Investigators

  • Principal Investigator: Massimo Conti, MD, Centre de Recherche IUCPQ - Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 31, 2018

Primary Completion (Anticipated)

August 31, 2019

Study Completion (Anticipated)

August 31, 2024

Study Registration Dates

First Submitted

August 21, 2018

First Submitted That Met QC Criteria

August 22, 2018

First Posted (Actual)

August 24, 2018

Study Record Updates

Last Update Posted (Actual)

August 24, 2018

Last Update Submitted That Met QC Criteria

August 22, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-2997, 21621

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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