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

Not Applicable

Not yet recruiting

• Conditions: Lung Cancer; Surgery; Circulating Tumor Cell
• Interventions: Procedure: Vein interruption before any other surgical manipulation; Procedure: Arteries interruption before vein interruption

• Registration Number: NCT03645252
• Lead Sponsor: Laval University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-08-22
• Last Update Submitted: 2018-08-22
• Study First Posted: 2018-08-24
• Last Update Posted: 2018-08-24
• Study Start: 2018-08-31
• Primary Completion: 2019-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vein first	Vein interruption before any other surgical manipulation	Tumor-draining pulmonary vein is interrupted first and before any surgical manipulation.
Arteries before vein	Arteries interruption before vein interruption	Lobar arteries (+/- bronchus and inter-lobar fissures) are interrupted before tumor-draining pulmonary vein.

Primary Outcome Measures

Name	Time	Method
Changes in CTC density	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).
Changes in CTC clusters density	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec; 🇨🇦 Québec, Canada