Clinical trial NCT03967652: Cancer Diagnoses From Exhaled Breath With Na-nose
Official title: Diagnosing Cancers From Healthy From Human Exhaled Breath With Na-nose
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Volatile Organic Compounds
Cancer
Diagnoses Disease
Keywords: Volatile organic chemicals
Cancer
Diagnose Disease
Na-nose
breath diagnoses
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
Collaborators: name: Technion, Israel Institute of Technology
First posted: 2019-05-30
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10,000 volunteers who had a definitively diagnosis with surgery or endoscope

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.

Eligibility criteria: 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

Primary outcomes:
measure: Build predictive diagnosis database
timeFrame: From July 01,2019 to December 31,2021
Secondary outcomes:
measure: Associated feature exhaled breath with differentially expressed genes
timeFrame: From Juan 01,2022 to December 31,2022
Other outcomes:
Locations:
Study officials:
affiliation: Anhui Provincial Hospital
name: Hu Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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