Volatil Organic Compounds in Exhaled Air and Sweat After Thoracic Surgery for Carcinological Resection (Onco-VOC)

Bronchopulmonary cancer, with 39 000 new cases and 30 000 deaths per year, is a main issue in public health in France. It is the leading cause of cancer death in France. A lot of progress in medical care has been made, but surgery remains the most effective treatment, when it is still possible. The goal is to detect and manage the lung cancer as early as possible. Alongside screening strategies by annual thoracic scanner, new approaches with innovative technologies open up for cancer detection and therapeutic follow-up.

The study of volatile organic compounds (VOC) detected in exhaled air or in sweat, is an innovative research area for respiratory diseases. The volatolomic analysis can be done either by the technique of the mass spectrometry which allows the identification of each VOC in the exhaled air or by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOC without identifying them. The VOC have shown their interest in some situations, such as diagnostic or prognostic tool in patients followed for thoracic tumorous pathology or bronchial or pulmonary vascular diseases.

The composition of VOC in exhaled air and sweat is altered in patients with lung cancer. The VOC analysis and their variation could be used particularly in the follow-up of patients treated for lung cancer.

The purpose of this clinical research is to identify the VOCs related to lung cancers by comparing the VOC profiles in exhaled air and in sweat from patients diagnosed with localized lung cancer before and after resection surgery.

Study Overview

• Status: Unknown
• Conditions: Lung Cancer, Non-small Cell
• Intervention / Treatment: Other: VOC analysis

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisabeth Hullier-Ammar; Phone Number: +33 1 46 25 11 75; Email: drci-promotion@hopital-foch.com

Study Locations

• France
  • Suresnes, France, 92150
    • Recruiting
    • Hopital Foch
    • Contact: Philippe Devillier; Phone Number: 33 1 46 25 27 91; Email: p.devillier@hopital-foch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient aged ≥ 18 years old
• Patient with non-small cell lung cancer
• Operable grade I or II
• No specific treatment before surgery (radiotherapy, chemotherapy or targeted therapy)
• Patient with healthcare insurance

Non Inclusion Criteria:

• Treatment with radiotherapy, chemotherapy, or neoadjuvant cancer targeted therapy before thoracic surgery
• Patient with oxygen therapy or invasive ventilation
• Patient unable to perform a slow vital capacity
• Dermatological therapy interfering with sweat collection (psoriasis, irritant dermatitis, for instance)
• Pregnant women
• Patient deprived of liberty by judicial or administrative decision

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VOC analysis; VOC analysis in exhaled air and sweat in patients with thoracic surgery for carcinological resection	Other: VOC analysis; VOC analysis in exhaled air with e-noses and mass spectrometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Volatil Organic Compound (VOC) profiles by mass spectrometry	Comparison of variation in Volatil Organic Compound (VOC) profiles in exhaled air of patients before and after surgery. The VOC will be identified by their molecular mass (by the mass spectrometry)	change from baseline profiles at 2 month post-surgery
Comparison of Volatil Organic Compound (VOC) profiles in by electronic noses	Comparison of variation in Volatil Organic Compound (VOC) profiles in exhaled air of patients before and after surgery. The VOC will be identified by the sensor deflection (by the electronic noses).	change from baseline profiles at 2 month post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Volatil Organic Compound (VOC) profiles in sweat	Comparison of Volatil Organic Compound (VOC) profiles in sweat of patients before and after surgery. The VOC will be identified by their molecular mass (by the mass spectrometry).	30 days before the surgery and 45 to 75 days after surgery
Variation of Volatil Organic Compound (VOC) and relapse rate	Correlation between the variation of Volatil Organic Compound (VOC) before-after surgery and relapse rate at 2 years	30 days before the surgery, 45 to 75 days after surgery and 2 years
Correlation between Volatil Organic Compound (VOC) profiles and relapse rate	Correlation between the Volatil Organic Compound (VOC) profiles 2 months after the surgery and relapse rate at 2 years	2 months and 2 years after surgery
Comparison of Volatil Organic Compound (VOC) profiles in exhaled air and tumoral lung tissue	Comparison of Volatil Organic Compound (VOC) profiles in exhaled air of patients and those released ex-vivo by the tumoral lung tissue. The VOC will be identified by their molecular mass (by the mass spectrometry).	30 days before the surgery, day of surgery and 45 to 75 days after surgery

Collaborators and Investigators

• Sponsor: Hopital Foch

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2018
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 2017081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No