Volatil Organic Compounds in Exhaled Air and Sweat After Thoracic Surgery for Carcinological Resection (Onco-VOC)
Primary Purpose
Lung Cancer, Non-small Cell
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
VOC analysis
Sponsored by
About this trial
This is an interventional other trial for Lung Cancer, Non-small Cell
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
Sites / Locations
- Hôpital FochRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VOC analysis
Arm Description
VOC analysis in exhaled air and sweat in patients with thoracic surgery for carcinological resection
Outcomes
Primary Outcome Measures
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)
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).
Secondary Outcome Measures
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).
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
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
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03803137
Brief Title
Volatil Organic Compounds in Exhaled Air and Sweat After Thoracic Surgery for Carcinological Resection
Acronym
Onco-VOC
Official Title
Volatil Organic Compounds in Exhaled Air and Sweat After Thoracic Surgery for Carcinological Resection
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Non-small Cell
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VOC analysis
Arm Type
Experimental
Arm Description
VOC analysis in exhaled air and sweat in patients with thoracic surgery for carcinological resection
Intervention Type
Other
Intervention Name(s)
VOC analysis
Intervention Description
VOC analysis in exhaled air with e-noses and mass spectrometry
Primary Outcome Measure Information:
Title
Comparison of Volatil Organic Compound (VOC) profiles by mass spectrometry
Description
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)
Time Frame
change from baseline profiles at 2 month post-surgery
Title
Comparison of Volatil Organic Compound (VOC) profiles in by electronic noses
Description
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).
Time Frame
change from baseline profiles at 2 month post-surgery
Secondary Outcome Measure Information:
Title
Comparison of Volatil Organic Compound (VOC) profiles in sweat
Description
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).
Time Frame
30 days before the surgery and 45 to 75 days after surgery
Title
Variation of Volatil Organic Compound (VOC) and relapse rate
Description
Correlation between the variation of Volatil Organic Compound (VOC) before-after surgery and relapse rate at 2 years
Time Frame
30 days before the surgery, 45 to 75 days after surgery and 2 years
Title
Correlation between Volatil Organic Compound (VOC) profiles and relapse rate
Description
Correlation between the Volatil Organic Compound (VOC) profiles 2 months after the surgery and relapse rate at 2 years
Time Frame
2 months and 2 years after surgery
Title
Comparison of Volatil Organic Compound (VOC) profiles in exhaled air and tumoral lung tissue
Description
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).
Time Frame
30 days before the surgery, day of surgery and 45 to 75 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Hullier-Ammar
Phone
+33 1 46 25 11 75
Email
drci-promotion@hopital-foch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Devillier
Organizational Affiliation
Pneumology department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Devillier
Phone
33 1 46 25 27 91
Email
p.devillier@hopital-foch.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Volatil Organic Compounds in Exhaled Air and Sweat After Thoracic Surgery for Carcinological Resection
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