Cancer Diagnoses From Exhaled Breath With Na-nose

• Conditions: Diagnoses Disease; Volatile Organic Compounds; Cancer
• Interventions: Diagnostic Test: Nanomaterial-based sensors

• Registration Number: NCT03967652
• Lead Sponsor: Anhui Medical University

Brief Summary

Early diagnoses of malignant tumors are pivotal for improving their prognoses. The Exhaled Breath is made up of oxygen, carbon dioxide, nitrogen, water, inert gases and volatile organic compounds (VOCs). Theoretically, the concentration of VOCs in exhalation produced by metabolism in human body is only about nmol/L-pmol/L, which can significantly increase under certain pathological conditions. A series of studies of VOCs diagnosing solid tumors the investigators had been conducted in the past decade. It was found that VOCs in exhaled breath can not only distinguish different types of tumors, but also can make a clear distinction between different stages. Our long-term collaborator, Professor Hossam Haick (Israel Institute of Technology) has developed a nano sensor array, so called Na-nose, which can detect VOCs of the exhaled breath by binding gases to specific chemiresistors coated with gold nanomaterials. The Na-nose has the advantages of low cost, easy to use, good reproducibility and real-time detection for large scale clinical application. This study was to use large clinical samples to validate the diagnostic efficacy of the newly developed Nano-nose( Sniffphone and Breath Screener) for malignant tumors .

Detailed Description

Israel Institute of Technology provides two type of Na-nose. One is Breath Screener used for large-scale sampling and feature VOCs extraction to establish database. The other is called Sniff Phone aim at clinical real-time VOCs detection assisted by software. About 10,000 patients will participate in the subject of Breath Screener in batches. First, 7000 patients will have a definitive diagnosis and exhaled breath collected. Feature VOCs of specific tumors will be extracted from these samples and employed to build predictive model by using discriminant factor analysis (DFA). After the predictive model had been completed, 3000 definitively diagnosed patients will participate in validating the specificity and sensitivity of the prediction model. With the assistance of Breath Screener clinical database and software services, Sniff Phone is more suitable for clinical real-time detection for its small and convenient design characteristics. At last, Breath Screener and Sniff Phone will continue enriching databases and improve diagnosis efficacy in their clinical applications.

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-05-27
• Last Update Submitted: 2019-05-29
• Study First Posted: 2019-05-30
• Last Update Posted: 2019-05-31
• Study Start: 2019-07-01
• Primary Completion: 2020-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• 18-75 years
• Cancer/benign disease having been diagnosed by pathology
• ECOG < 2

Exclusion Criteria

• Concomitant malignancies other than one malignant tumor
• Diabetes, Fatty liver
• Autoimmune disease
• Ventilation and transaired function obstacle

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal	Nanomaterial-based sensors	Healthy volunteers
cancer	Nanomaterial-based sensors	Patients with definitively diagnosed of solid tumors
Benign disease	Nanomaterial-based sensors	Patients with definitively diagnosed of benign disease or precancerous lesion

Primary Outcome Measures

Name	Time	Method
Build predictive diagnosis database	From July 01,2019 to December 31,2021	First, feature VOCs of specific tumors will be extracted from part of collected samples and employed to build predictive model. After the predictive model had been completed, number of definitively diagnosed patients will participate in validating the specificity and sensitivity of the prediction model.

Secondary Outcome Measures

Name	Time	Method
Associated feature exhaled breath with differentially expressed genes	From Juan 01,2022 to December 31,2022	Integrate the correlation and relevance between the exhaled samples and the differentially expressed genes in the cancer group and the benign / normal control group to explore the mechanism of feature VOCs' production.