Circulating Tumor Cells (CTC) Before and After Thoracic Resection With and Without Intraoperative Use of ExtraCorporeal Membrane Oxygenator(ECMO) or Cardio Pulmonary By Pass (CPB)

NCT04048512 | Unknown

• 1 other identifier: R1005/19-IEO 1060
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The role of circulating tumor cells (CTC) in patients suffering from lung cancer and thoracic malignancies is not well known and it is still widely debated. The use of intraoperative cardiorespiratory supports like ECMO (extracorporeal membrane oxygenator) and CPB (cardiopulmonary by-pass) during extended resections in oncologic patients has been questioned because of the theoretical risk of tumor cells spreading, although there is no clinical or experimental evidence supporting this hypothesis. The aim of the present study is to quantify the possible presence and amount of CTC in the peripheral blood of patients undergoing lung/mediastinal resection, before and after surgical procedure, comparing patients receiving intraoperative cardiorespiratory support with patients - with similar oncologic disease and extension - operated without the need of ECMO or CPB.

Conditions

Thoracic Surgery; Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

• Assessment of the number of circulating tumor cells the day before surgery and first post operative day (24 hours after surgery)

  Quantification of CTC (number) in peripheral blood

  The day before surgery and the first post operative day (24 hours after surgery)

Study Arms (2)

Resection with intraoperative ECMO/CPB

Patients suffering of neoplastic thoracic disease, undergoing thoracic resection with intraoperative use of Extra Corporeal Membrane Oxygenator (ECMO) or Cardio Pulmonary By pass (CPB)

Procedure: Resection with intraoperative use of ECMO/CPB

Resection without intraoperative ECMO/CPB

Patients suffering of neoplastic thoracic disease, undergoing thoracic resection without intraoperative use of Extra Corporeal Membrane Oxygenator (ECMO) or Cardio pulmonary By Pass (CPB)

Procedure: Resection without intraoperative use of ECMO/CPB

Interventions

Resection with intraoperative use of ECMO/CPB PROCEDURE

Patients are operated with the use of intraoperative ECMO/CPB

Resection with intraoperative ECMO/CPB

Resection without intraoperative use of ECMO/CPB PROCEDURE

Patients are operated without the use of intraoperative ECMO/CPB

Resection without intraoperative ECMO/CPB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ten consecutive patients with planned intraoperative cardiorespiratory support will be enrolled and blood samples will be collected to search for CTC. The patients will then undergo operation with Extra Corporeal membarne Oxygenator (ECMO) or Cardio Pulmonary By Pass (CPB) support. After the procedure peripheral blood samples will be collected as previously reported to search for Circulating Tumor Cells (CTC). Ten consecutive patients, presenting the same neoplastic diseases of the experimental arm and with same extension but not requiring intraoperative ECMO or CPB support will be enrolled in the control arm, receiving the same blood sample collection before and after surgery, to assess the presence and the amount of CTC. The two groups will be than compared in terms of preoperative and postoperative CTC presence and amount.

You may qualify if:

• Thoracic resection (lung and or mediastinal resection) requiring intraoperative Extra Coprporeal Membrane Oxygenator (ECMO) or Cardio Pulmonary By pass (CPB) support; in the control group same disease and planned procedure to be performed without the need of EMCO or CPB.
• Infiltration of the main carina
• Infiltration of superior vena cava
• Single lung surgery
• Mediastinal involvment

You may not qualify if:

• Age younger than 18 years
• Contraindications to general anesthesia
• Poor general clinical conditions ( ECOG PS \>=2)
• Patients unable to provide informed consent

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institue of Oncology

Milan, 20143, Italy

RECRUITING

Related Publications (10)

• Spira A, Ettinger DS. Multidisciplinary management of lung cancer. N Engl J Med. 2004 Jan 22;350(4):379-92. doi: 10.1056/NEJMra035536. No abstract available.

  PMID: 14736930 BACKGROUND

• Rice TW, Blackstone EH. Radical resections for T4 lung cancer. Surg Clin North Am. 2002 Jun;82(3):573-87. doi: 10.1016/s0039-6109(02)00017-8.

  PMID: 12371586 BACKGROUND

• Regnard JF, Perrotin C, Giovannetti R, Schussler O, Petino A, Spaggiari L, Alifano M, Magdeleinat P. Resection for tumors with carinal involvement: technical aspects, results, and prognostic factors. Ann Thorac Surg. 2005 Nov;80(5):1841-6. doi: 10.1016/j.athoracsur.2005.04.032.

  PMID: 16242466 BACKGROUND

• de Perrot M, Fadel E, Mercier O, Mussot S, Chapelier A, Dartevelle P. Long-term results after carinal resection for carcinoma: does the benefit warrant the risk? J Thorac Cardiovasc Surg. 2006 Jan;131(1):81-9. doi: 10.1016/j.jtcvs.2005.07.062. Epub 2005 Dec 5.

  PMID: 16399298 BACKGROUND

• Perentes J, Bopp S, Krueger T, Gonzalez M, Jayet PY, Lovis A, Matzinger O, Ruffieux C, Ris HB, Letovanec I, Peters S. Impact of lung function changes after induction radiochemotherapy on resected T4 non-small cell lung cancer outcome. Ann Thorac Surg. 2012 Dec;94(6):1815-22. doi: 10.1016/j.athoracsur.2012.08.054. Epub 2012 Oct 25.

  PMID: 23103000 BACKGROUND

• Tsuchiya R, Asamura H, Kondo H, Goya T, Naruke T. Extended resection of the left atrium, great vessels, or both for lung cancer. Ann Thorac Surg. 1994 Apr;57(4):960-5. doi: 10.1016/0003-4975(94)90214-3.

  PMID: 8166550 BACKGROUND

• Rao V, Todd TR, Weisel RD, Komeda M, Cohen G, Ikonomidis JS, Christakis GT. Results of combined pulmonary resection and cardiac operation. Ann Thorac Surg. 1996 Aug;62(2):342-6; discussion 346-7.

  PMID: 8694588 BACKGROUND

• Lang G, Ghanim B, Hotzenecker K, Klikovits T, Matilla JR, Aigner C, Taghavi S, Klepetko W. Extracorporeal membrane oxygenation support for complex tracheo-bronchial proceduresdagger. Eur J Cardiothorac Surg. 2015 Feb;47(2):250-5; discussion 256. doi: 10.1093/ejcts/ezu162. Epub 2014 Apr 16.

  PMID: 24740936 BACKGROUND

• Lang G, Taghavi S, Aigner C, Charchian R, Matilla JR, Sano A, Klepetko W. Extracorporeal membrane oxygenation support for resection of locally advanced thoracic tumors. Ann Thorac Surg. 2011 Jul;92(1):264-70. doi: 10.1016/j.athoracsur.2011.04.001.

  PMID: 21718853 BACKGROUND

• Brutel de la Riviere A, Knaepen P, Van Swieten H, Vanderschueren R, Ernst J, Van den Bosch J. Concomitant open heart surgery and pulmonary resection for lung cancer. Eur J Cardiothorac Surg. 1995;9(6):310-3; discussion 313-4. doi: 10.1016/s1010-7940(05)80188-5.

  PMID: 7546803 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

Study Officials

• Francesco Petrella

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Petrella, MD, PhD

CONTACT

00393388231311; francesco.petrella@ieo.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 7, 2019
• Study Start: August 22, 2019
• Primary Completion: July 22, 2021
• Study Completion: October 30, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)