Clinical trial NCT03645252: Sequence of Vessel Interruption and Circulating Tumor Cells in Surgical Lung Cancer
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
Overall status: UNKNOWN
Phase: NA
Conditions: Circulating Tumor Cell
Lung Cancer
Surgery
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
First posted: 2018-08-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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)

Primary outcomes:
measure: Changes in CTC density
timeFrame: Within 96 hours after surgery
measure: Changes in CTC clusters density
timeFrame: Within 96 hours after surgery
Secondary outcomes:
measure: Disease free survival
timeFrame: 2 years and 5 years after surgery
measure: Overall survival
timeFrame: 2 years and 5 years after surgery
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec
Study officials:
affiliation: Centre de Recherche IUCPQ - Laval University
name: Massimo Conti, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.