NCT03645252

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

August 31, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

August 21, 2018

Last Update Submit

August 22, 2018

Conditions

Circulating Tumor CellLung CancerSurgery

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Disease free survival

    2 years and 5 years after surgery

  • Overall survival

    2 years and 5 years after surgery

Study Arms (2)

Vein first

ACTIVE COMPARATOR

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

Procedure: Vein interruption before any other surgical manipulation

Arteries before vein

ACTIVE COMPARATOR

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

Procedure: Arteries interruption before vein interruption

Interventions

Vein interruption before any other surgical manipulationPROCEDURE

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.

Vein first
Arteries interruption before vein interruptionPROCEDURE

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.

Arteries before vein

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, G1V 4G5, Canada

Location

Related Publications (2)

  • 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.

    PMID: 27468936RESULT

  • 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.

    PMID: 24618055RESULT

MeSH Terms

Conditions

Neoplastic Cells, CirculatingLung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Study Officials

  • Massimo Conti, MD

    Centre de Recherche IUCPQ - Laval University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Conti Massimo, MD

CONTACT

+14186568711massimo.conti@criucpq.ulaval.ca

Marie-Hélène Lavoie

CONTACT

+14186568711marie.helene.lavoie@ssss.gouv.qc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 24, 2018

Study Start

August 31, 2018

Primary Completion

August 31, 2019

Study Completion

August 31, 2024

Last Updated

August 24, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)