Clinical trial NCT03803137: Volatil Organic Compounds in Exhaled Air and Sweat After Thoracic Surgery for Carcinological Resection
Official title: Volatil Organic Compounds in Exhaled Air and Sweat After Thoracic Surgery for Carcinological Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer, Non-small Cell
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of Volatil Organic Compound (VOC) profiles by mass spectrometry
timeFrame: change from baseline profiles at 2 month post-surgery
measure: Comparison of Volatil Organic Compound (VOC) profiles in by electronic noses
timeFrame: change from baseline profiles at 2 month post-surgery
Secondary outcomes:
measure: Comparison of Volatil Organic Compound (VOC) profiles in sweat
timeFrame: 30 days before the surgery and 45 to 75 days after surgery
measure: Variation of Volatil Organic Compound (VOC) and relapse rate
timeFrame: 30 days before the surgery, 45 to 75 days after surgery and 2 years
measure: Correlation between Volatil Organic Compound (VOC) profiles and relapse rate
timeFrame: 2 months and 2 years after surgery
measure: Comparison of Volatil Organic Compound (VOC) profiles in exhaled air and tumoral lung tissue
timeFrame: 30 days before the surgery, day of surgery and 45 to 75 days after surgery
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Pneumology department
name: Philippe Devillier
role: PRINCIPAL_INVESTIGATOR
References: