Cancer Diagnoses From Exhaled Breath With Na-nose

NCT ID: NCT03967652

Last Updated: 2019-05-31

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2022-12-31

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.

Conditions

Volatile Organic Compounds; Cancer; Diagnoses Disease

Keywords

Volatile organic chemicals; Cancer; Diagnose Disease; Na-nose; breath diagnoses

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

cancer

Patients with definitively diagnosed of solid tumors

Nanomaterial-based sensors

Intervention Type: DIAGNOSTIC_TEST

Chemical sensors based on Monolayer-Capped Metallic Nanoparticles (MCMNPs) can recognize and classify exhaled breath by special recognition algorithm, which achieves the purpose of disease diagnosis.

Benign disease

Patients with definitively diagnosed of benign disease or precancerous lesion

Nanomaterial-based sensors

Intervention Type: DIAGNOSTIC_TEST

Chemical sensors based on Monolayer-Capped Metallic Nanoparticles (MCMNPs) can recognize and classify exhaled breath by special recognition algorithm, which achieves the purpose of disease diagnosis.

Normal

Healthy volunteers

Nanomaterial-based sensors

Intervention Type: DIAGNOSTIC_TEST

Chemical sensors based on Monolayer-Capped Metallic Nanoparticles (MCMNPs) can recognize and classify exhaled breath by special recognition algorithm, which achieves the purpose of disease diagnosis.

Interventions

Nanomaterial-based sensors

Chemical sensors based on Monolayer-Capped Metallic Nanoparticles (MCMNPs) can recognize and classify exhaled breath by special recognition algorithm, which achieves the purpose of disease diagnosis.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Technion, Israel Institute of Technology

OTHER

Sponsor Role: collaborator

Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hu Liu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hu Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Anhui Provincial Hospital

Central Contacts

Bao Chuyang, MD

Role: CONTACT

Phone: +86 18555039598

Email: des_mond@outlook.com

Hu Liu, MD

Role: CONTACT

Phone: +86 13866175691

Email: drliuhu@yahoo.com

References

Barash O, Zhang W, Halpern JM, Hua QL, Pan YY, Kayal H, Khoury K, Liu H, Davies MP, Haick H. Differentiation between genetic mutations of breast cancer by breath volatolomics. Oncotarget. 2015 Dec 29;6(42):44864-76. doi: 10.18632/oncotarget.6269.

Reference Type: BACKGROUND

PMID: 26540569 (View on PubMed)

Amal H, Shi DY, Ionescu R, Zhang W, Hua QL, Pan YY, Tao L, Liu H, Haick H. Assessment of ovarian cancer conditions from exhaled breath. Int J Cancer. 2015 Mar 15;136(6):E614-22. doi: 10.1002/ijc.29166. Epub 2014 Sep 5.

Reference Type: BACKGROUND

PMID: 25159530 (View on PubMed)

Amal H, Leja M, Broza YY, Tisch U, Funka K, Liepniece-Karele I, Skapars R, Xu ZQ, Liu H, Haick H. Geographical variation in the exhaled volatile organic compounds. J Breath Res. 2013 Dec;7(4):047102. doi: 10.1088/1752-7155/7/4/047102. Epub 2013 Nov 1.

Reference Type: BACKGROUND

PMID: 24184568 (View on PubMed)

Leja MA, Liu H, Haick H. Breath testing: the future for digestive cancer detection. Expert Rev Gastroenterol Hepatol. 2013 Jul;7(5):389-91. doi: 10.1586/17474124.2013.811033. No abstract available.

Reference Type: BACKGROUND

PMID: 23899275 (View on PubMed)

Nakhleh MK, Amal H, Jeries R, Broza YY, Aboud M, Gharra A, Ivgi H, Khatib S, Badarneh S, Har-Shai L, Glass-Marmor L, Lejbkowicz I, Miller A, Badarny S, Winer R, Finberg J, Cohen-Kaminsky S, Perros F, Montani D, Girerd B, Garcia G, Simonneau G, Nakhoul F, Baram S, Salim R, Hakim M, Gruber M, Ronen O, Marshak T, Doweck I, Nativ O, Bahouth Z, Shi DY, Zhang W, Hua QL, Pan YY, Tao L, Liu H, Karban A, Koifman E, Rainis T, Skapars R, Sivins A, Ancans G, Liepniece-Karele I, Kikuste I, Lasina I, Tolmanis I, Johnson D, Millstone SZ, Fulton J, Wells JW, Wilf LH, Humbert M, Leja M, Peled N, Haick H. Diagnosis and Classification of 17 Diseases from 1404 Subjects via Pattern Analysis of Exhaled Molecules. ACS Nano. 2017 Jan 24;11(1):112-125. doi: 10.1021/acsnano.6b04930. Epub 2016 Dec 21.

Reference Type: BACKGROUND

PMID: 28000444 (View on PubMed)

Amal H, Ding L, Liu BB, Tisch U, Xu ZQ, Shi DY, Zhao Y, Chen J, Sun RX, Liu H, Ye SL, Tang ZY, Haick H. The scent fingerprint of hepatocarcinoma: in-vitro metastasis prediction with volatile organic compounds (VOCs). Int J Nanomedicine. 2012;7:4135-46. doi: 10.2147/IJN.S32680. Epub 2012 Jul 30.

Reference Type: BACKGROUND

PMID: 22888249 (View on PubMed)

Xu ZQ, Broza YY, Ionsecu R, Tisch U, Ding L, Liu H, Song Q, Pan YY, Xiong FX, Gu KS, Sun GP, Chen ZD, Leja M, Haick H. A nanomaterial-based breath test for distinguishing gastric cancer from benign gastric conditions. Br J Cancer. 2013 Mar 5;108(4):941-50. doi: 10.1038/bjc.2013.44.

Reference Type: BACKGROUND

PMID: 23462808 (View on PubMed)

Other Identifiers

NanoBreathDiag

Identifier Type: -

Identifier Source: org_study_id