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

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ClinicalTrials.gov Identifier: NCT03803137
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

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.


Condition or disease Intervention/treatment Phase
Lung Cancer, Non-small Cell Other: VOC analysis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Volatil Organic Compounds in Exhaled Air and Sweat After Thoracic Surgery for Carcinological Resection
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

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




Primary Outcome Measures :
  1. Comparison of Volatil Organic Compound (VOC) profiles by mass spectrometry [ Time Frame: change from baseline profiles at 2 month post-surgery ]
    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)

  2. Comparison of Volatil Organic Compound (VOC) profiles in by electronic noses [ Time Frame: change from baseline profiles at 2 month post-surgery ]
    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 :
  1. Comparison of Volatil Organic Compound (VOC) profiles in sweat [ Time Frame: 30 days before the surgery and 45 to 75 days after surgery ]
    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).

  2. Variation of Volatil Organic Compound (VOC) and relapse rate [ Time Frame: 30 days before the surgery, 45 to 75 days after surgery and 2 years ]
    Correlation between the variation of Volatil Organic Compound (VOC) before-after surgery and relapse rate at 2 years

  3. Correlation between Volatil Organic Compound (VOC) profiles and relapse rate [ Time Frame: 2 months and 2 years after surgery ]
    Correlation between the Volatil Organic Compound (VOC) profiles 2 months after the surgery and relapse rate at 2 years

  4. Comparison of Volatil Organic Compound (VOC) profiles in exhaled air and tumoral lung tissue [ Time Frame: 30 days before the surgery, day of surgery and 45 to 75 days after surgery ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803137


Contacts
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Contact: Elisabeth Hullier-Ammar +33 1 46 25 11 75 drci-promotion@hopital-foch.com

Locations
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France
Hôpital Foch Recruiting
Suresnes, France, 92150
Contact: Philippe Devillier    33 1 46 25 27 91    p.devillier@hopital-foch.com   
Sponsors and Collaborators
Hopital Foch
Investigators
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Principal Investigator: Philippe Devillier Pneumology department
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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT03803137    
Other Study ID Numbers: 2017081
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases