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

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: Lung Cancer; Surgery; Circulating Tumor Cell
• Intervention / Treatment: Procedure: Vein interruption before any other surgical manipulation; Procedure: Arteries interruption before vein interruption

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Conti Massimo, MD; Phone Number: 3853 +14186568711; Email: massimo.conti@criucpq.ulaval.ca
• Study Contact Backup: Name: Marie-Hélène Lavoie; Phone Number: 5504 +14186568711; Email: marie.helene.lavoie@ssss.gouv.qc.ca

Study Locations

• Canada
  • Québec, Canada, G1V 4G5
    • Institut universitaire de Cardiologie et de Pneumologie de Quebec
    • Contact: Massimo Conti, MD; Phone Number: 3853 +14186568711; Email: massimo.conti@criucpq.ulaval.ca
    • Sub-Investigator: Jérémy Tricard, MD
    • Sub-Investigator: Rosaire Vaillancourt, MD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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	Overall survival 2 years and 5 years after surgery.	2 years and 5 years after surgery

Collaborators and Investigators

• 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

General Publications

• 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.
• 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.

Study record dates

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: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Lung Neoplasms; Neoplastic Cells, Circulating
• 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