The Value of VOCs Analysis in Exhaled Breath for Pulmonary Benign and Malignant Lesion Diagnosis (VOCs)

November 14, 2016 updated by: Chen Liang_An, Chinese PLA General Hospital
The purpose of this study is to analysis the volatile organic gases(VOCs) in exhaled breath of pulmonary lesion patients and healthy controls, in order to find the difference of composition and concentration among groups.

Study Overview

Status

Unknown

Conditions

Detailed Description

Collect the exhaled gas in pulmonary lesion patients and healthy controls, using proton transfer reaction mass spectrometry to analysis the different composition and concentration of VOCs, to find the biomarker gases of distinguishing benign and malignant lesion of lung among different groups， and try to build a diagnostic model for lung lesion.

Study Type

Observational

Enrollment (Anticipated)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • department of respiratory department ,Chinese PLA general hospital
        • Contact:
          • Liang-an Chen, MD,PHD
          • Phone Number: 8610-55499027
          • Email: cla301@126.com
        • Principal Investigator:
          • Liang-an Chen, MD,PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with lung disease or healthy controls without lung diseases， and can cooperate with the collection of exhaled breath.

Description

Inclusion Criteria:

  • cohort 1 :

Inclusion criteria:

Patients newly diagnosed with primary lung cancer by tissue biopsy and did not receive any treatment aiming at the tumor, including chemotherapy and radiotherapy.

Age ≥ 18 years

  • cohort 2： Inclusion criteria： Patients diagnosed with pulmonary benign lesion by tissue biopsy or other examination.

Age ≥ 18 years

Exclusion Criteria:

patients who have more than one type of carcinoma patients diagnosed type 2 diabetes mellitus patients diagnosed chronic renal failure patients diagnosed upper digestive tract ulcer patients who reject to sign the informed consent from

  • cohort 3： Healthy controls Volunteers without diagnosed lung diseases and pulmonary symptoms.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Primary lung cancer
patients newly diagnosed with lung cancer by tissue biopsy and did not receive any treatment aiming at the tumor, including chemotherapy and radiotherapy.
Benign lung lesion
Patients diagnosed with pulmonary benign diseases.
Healthy control
Patients without any pulmonary abnormal symptoms or diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mass-to-charge Ratio
Time Frame: 6 months
It is the measurement result of VOCs in exhaled breath using PTR-MS device.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Principal Investigator: Liang-an Chen, MD,PHD, Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

November 14, 2016

First Submitted That Met QC Criteria

November 14, 2016

First Posted (Estimate)

November 16, 2016

Study Record Updates

Last Update Posted (Estimate)

November 16, 2016

Last Update Submitted That Met QC Criteria

November 14, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2016-110-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

considering of personal privacy, the research-related individual participant data do not intend for public sharing.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe