Volatil Organic Compounds in Exhaled Air and Sweat After Thoracic Surgery for Carcinological Resection

NCT03803137 | Unknown

• 1 other identifier: 2017081
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer, Non-small Cell

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Comparison of Volatil Organic Compound (VOC) profiles in sweat

  30 days before the surgery and 45 to 75 days after surgery

• Variation of Volatil Organic Compound (VOC) and relapse rate

  30 days before the surgery, 45 to 75 days after surgery and 2 years

• Correlation between Volatil Organic Compound (VOC) profiles and relapse rate

  2 months and 2 years after surgery

• Comparison of Volatil Organic Compound (VOC) profiles in exhaled air and tumoral lung tissue

  30 days before the surgery, day of surgery and 45 to 75 days after surgery

Study Arms (1)

VOC analysis

EXPERIMENTAL

VOC analysis in exhaled air and sweat in patients with thoracic surgery for carcinological resection

Other: VOC analysis

Interventions

VOC analysis OTHER

VOC analysis in exhaled air with e-noses and mass spectrometry

VOC analysis

Eligibility Criteria

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

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hôpital Foch

Suresnes, 92150, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Philippe Devillier

  Pneumology department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabeth Hullier-Ammar

CONTACT

+33 1 46 25 11 75; drci-promotion@hopital-foch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: January 14, 2019
• Study Start: September 20, 2018
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: December 19, 2020

Record last verified: 2020-12

Locations

FR (1)