NCT03967652

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 31, 2019

Status Verified

May 1, 2019

Enrollment Period

1.5 years

First QC Date

May 27, 2019

Last Update Submit

May 29, 2019

Conditions

Volatile Organic CompoundsCancerDiagnoses Disease

Keywords

Volatile organic chemicalsCancerDiagnose DiseaseNa-nosebreath diagnoses

Outcome Measures

Primary Outcomes (1)

  • Build predictive diagnosis database

    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.

    From July 01,2019 to December 31,2021

Secondary Outcomes (1)

  • Associated feature exhaled breath with differentially expressed genes

    From Juan 01,2022 to December 31,2022

Study Arms (3)

cancer

Patients with definitively diagnosed of solid tumors

Diagnostic Test: Nanomaterial-based sensors

Benign disease

Patients with definitively diagnosed of benign disease or precancerous lesion

Diagnostic Test: Nanomaterial-based sensors

Normal

Healthy volunteers

Diagnostic Test: Nanomaterial-based sensors

Interventions

Nanomaterial-based sensorsDIAGNOSTIC_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 diseaseNormalcancer

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

10,000 volunteers who had a definitively diagnosis with surgery or endoscope

You may qualify if:

  • years
  • Cancer/benign disease having been diagnosed by pathology
  • ECOG \< 2

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 28000444BACKGROUND

  • 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.

    PMID: 26540569BACKGROUND

  • 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.

    PMID: 25159530BACKGROUND

  • 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.

    PMID: 24184568BACKGROUND

  • 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.

    PMID: 23899275BACKGROUND

  • 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.

    PMID: 22888249BACKGROUND

  • 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.

    PMID: 23462808BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Hu Liu, MD

    Anhui Provincial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bao Chuyang, MD

CONTACT

+86 18555039598des_mond@outlook.com

Hu Liu, MD

CONTACT

+86 13866175691drliuhu@yahoo.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 27, 2019

First Posted

May 30, 2019

Study Start

July 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2022

Last Updated

May 31, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share