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

Primary Purpose

Circulating Tumor Cell, Lung Cancer, Surgery

Status

Not yet recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Vein interruption before any other surgical manipulation

Arteries interruption before vein interruption

About this trial

This is an interventional other trial for Circulating Tumor Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Vein first

Arteries before vein

Arm Description

Tumor-draining pulmonary vein is interrupted first and before any surgical manipulation.

Lobar arteries (+/- bronchus and inter-lobar fissures) are interrupted before tumor-draining pulmonary vein.

Outcomes

Primary Outcome Measures

Changes in CTC density

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).

Changes in CTC clusters density

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).

Secondary Outcome Measures

Disease free survival

Disease free survival 2 years and 5 years after surgery and recurrence site (local or distant metastasis).

Overall survival

Overall survival 2 years and 5 years after surgery.

Full Information

NCT ID

NCT03645252

First Posted

August 21, 2018

Last Updated

August 22, 2018

Sponsor

Laval University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03645252

Brief Title

Sequence of Vessel Interruption and Circulating Tumor Cells in Surgical Lung Cancer

Acronym

CTC-01

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 31, 2018 (Anticipated)

Primary Completion Date

August 31, 2019 (Anticipated)

Study Completion Date

August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Laval University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Circulating Tumor Cell, Lung Cancer, Surgery

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vein first

Arm Type

Active Comparator

Arm Description

Tumor-draining pulmonary vein is interrupted first and before any surgical manipulation.

Arm Title

Arteries before vein

Arm Type

Active Comparator

Arm Description

Lobar arteries (+/- bronchus and inter-lobar fissures) are interrupted before tumor-draining pulmonary vein.

Intervention Type

Procedure

Intervention Name(s)

Vein interruption before any other surgical manipulation

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Arteries interruption before vein interruption

Intervention Description

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.

Primary Outcome Measure Information:

Title

Changes in CTC density

Description

Time Frame

Within 96 hours after surgery

Title

Changes in CTC clusters density

Description

Time Frame

Within 96 hours after surgery

Secondary Outcome Measure Information:

Title

Disease free survival

Description

Disease free survival 2 years and 5 years after surgery and recurrence site (local or distant metastasis).

Time Frame

2 years and 5 years after surgery

Title

Overall survival

Description

Overall survival 2 years and 5 years after surgery.

Time Frame

2 years and 5 years after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Conti Massimo, MD

Phone

+14186568711

Ext

3853

massimo.conti@criucpq.ulaval.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Marie-Hélène Lavoie

Phone

+14186568711

Ext

5504

marie.helene.lavoie@ssss.gouv.qc.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Massimo Conti, MD

Organizational Affiliation

Centre de Recherche IUCPQ - Laval University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Universitaire de Cardiologie et de Pneumologie de Québec

City

Québec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Massimo Conti, MD

Phone

+14186568711

Ext

3853

massimo.conti@criucpq.ulaval.ca

First Name & Middle Initial & Last Name & Degree

Jérémy Tricard, MD

First Name & Middle Initial & Last Name & Degree

Rosaire Vaillancourt, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27468936

Citation

Crosbie PA, Shah R, Krysiak P, Zhou C, Morris K, Tugwood J, Booton R, Blackhall F, Dive C. Circulating Tumor Cells Detected in the Tumor-Draining Pulmonary Vein Are Associated with Disease Recurrence after Surgical Resection of NSCLC. J Thorac Oncol. 2016 Oct;11(10):1793-7. doi: 10.1016/j.jtho.2016.06.017. Epub 2016 Jul 25.

Results Reference

result

PubMed Identifier

24618055

Citation

Hashimoto M, Tanaka F, Yoneda K, Takuwa T, Matsumoto S, Okumura Y, Kondo N, Tsubota N, Tsujimura T, Tabata C, Nakano T, Hasegawa S. Significant increase in circulating tumour cells in pulmonary venous blood during surgical manipulation in patients with primary lung cancer. Interact Cardiovasc Thorac Surg. 2014 Jun;18(6):775-83. doi: 10.1093/icvts/ivu048. Epub 2014 Mar 11.

Results Reference

result

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Sequence of Vessel Interruption and Circulating Tumor Cells in Surgical Lung Cancer

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