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

Sponsor

Laval University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03645252

Collaborator

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Circulating Tumor Cell Lung Cancer Surgery	Procedure: Vein interruption before any other surgical manipulation Procedure: Arteries interruption before vein interruption	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Other

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.

Anticipated Study Start Date :

Aug 31, 2018

Anticipated Primary Completion Date :

Aug 31, 2019

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Québec		Canada	G1V 4G5

Sponsors and Collaborators

Laval University
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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Massimo Conti, Medical Doctor, Laval University

ClinicalTrials.gov Identifier:

NCT03645252

Other Study ID Numbers:

2019-2997, 21621

First Posted:

Aug 24, 2018

Last Update Posted:

Aug 24, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Neoplasms

Neoplastic Cells, Circulating

Study Results

No Results Posted as of Aug 24, 2018