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

Lung Neoplasm Clinical Trial

— VOCs  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02965300
• Other study ID #: S2016-110-01
• Status: Recruiting
• Phase: N/A
• First received: November 14, 2016
• Last updated: November 14, 2016
• Start date: October 2016
• Est. completion date: August 2017

Study information

• Verified date: November 2016
• Source: Chinese PLA General Hospital
• Contact: Liang—an Chen, MD,PHD
• Phone: 8610-55499027
• Email: cla301[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: August 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Disease
• Lung Diseases
• Lung Neoplasm
• Lung Neoplasms

Locations

Country	Name	City	State
China	department of respiratory department ,Chinese PLA general hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mass-to-charge Ratio	It is the measurement result of VOCs in exhaled breath using PTR-MS device.	6 months	No