Volatile Organic CompoundsNCT03967652
Cancer Diagnoses From Exhaled Breath With Na-nose
An observational study of Volatile Organic Compounds and Cancer, run by Anhui Medical University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Volatile Organic Compounds, Cancer, Diagnoses Disease
- What is being tested?
- Nanomaterial-based sensors
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 10,000 volunteers who had a definitively diagnosis with surgery or endoscope
Who may be able to join
- 18-75 years
- Cancer/benign disease having been diagnosed by pathology
- ECOG < 2
Who cannot join
- Concomitant malignancies other than one malignant tumor
- Diabetes, Fatty liver
- Autoimmune disease
- Ventilation and transaired function obstacle
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Diagnosing Cancers From Healthy From Human Exhaled Breath With Na-nose
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 .
Read the 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
- Being tested
- Nanomaterial-based sensors
- Keywords
- Volatile organic chemicals, Cancer, Diagnose Disease, Na-nose, breath diagnoses
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| cancer | Patients with definitively diagnosed of solid tumors Receives: Diagnostic Test: Nanomaterial-based sensors | |
| Benign disease | Patients with definitively diagnosed of benign disease or precancerous lesion Receives: Diagnostic Test: Nanomaterial-based sensors | |
| Normal | Healthy volunteers Receives: Diagnostic Test: Nanomaterial-based sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From July 01,2019 to December 31,2021
Secondary outcomes (1)
Associated feature exhaled breath with differentially expressed genes
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.
Measured: From Juan 01,2022 to December 31,2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start1 Jul 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Volatile Organic CompoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Responsible party
- Principal investigator, Hu Liu, Anhui Provincial Hospital
- Investigators
- Hu Liu, MD, Principal investigator, Anhui Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967652
- Sponsor's protocol ID
- NanoBreathDiag
- Status last verified
- May 2019
- First submitted
- 27 May 2019
- Last updated
- 31 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28000444Barash 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.
PubMed 26540569Amal 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.
PubMed 25159530Amal 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.
PubMed 24184568Leja 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.
PubMed 23899275Amal 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.
PubMed 22888249Xu 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.
PubMed 23462808
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosing Cancers From Healthy From Human Exhaled Breath With Na-nose
- ClinicalTrials.gov ID
- NCT03967652
- Acronym / sponsor ID
- NanoBreathDiag
- Conditions
- Volatile Organic Compounds, Cancer, Diagnoses Disease
- Keywords
- Volatile organic chemicals, Cancer, Diagnose Disease, Na-nose, breath diagnoses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cancer | – | Diagnostic Test: Nanomaterial-based sensorsPatients with definitively diagnosed of solid tumors |
| Benign disease | – | Diagnostic Test: Nanomaterial-based sensorsPatients with definitively diagnosed of benign disease or precancerous lesion |
| Normal | – | Diagnostic Test: Nanomaterial-based sensorsHealthy volunteers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 10,000 volunteers who had a definitively diagnosis with surgery or endoscope
Key inclusion criteria (3 listed)
- 18-75 years
- Cancer/benign disease having been diagnosed by pathology
- ECOG < 2
Key exclusion criteria (4 listed)
- Concomitant malignancies other than one malignant tumor
- Diabetes, Fatty liver
- Autoimmune disease
- Ventilation and transaired function obstacle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanomaterial-based sensorsChemical 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. | Diagnostic test | Benign disease, Normal, cancer |
Primary outcome
Build predictive diagnosis database
Time frame: 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.
1 secondary outcome
Associated feature exhaled breath with differentially expressed genes
Time frame: From Juan 01,2022 to December 31,2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Background: PubMed 28000444Nakhleh 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.
- Background: PubMed 26540569Barash 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.
- Background: PubMed 25159530Amal 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.
- Background: PubMed 24184568Amal 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.
- Background: PubMed 23899275Leja 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.
- Background: PubMed 22888249Amal 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.
- Background: PubMed 23462808Xu 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.
- Individual participant dataSharing planned: No
Related trials for Volatile Organic Compounds
Not yet recruitingObservational study
Non-Invasive Biomarker Monitoring in UC on Biologics
Ulcerative Colitis
Recruiting
Vocxi Breath Analyzer Study in Pediatric Respiratory Infection
Acute Respiratory Illness, Viral Respiratory Infection
RecruitingObservational study
Lung Cancer Detection in Never Smokers Using Urine Volatile Organic Compound (VOCs)
Lung Cancer
Recruiting
Using E-Nose Technology to Measure Response to Treatment in People With Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma
RecruitingObservational study
Identifying Patterns in the Breath of Individuals With Breast Cancer
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hu Liu, MD principal investigator
Anhui Provincial Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Volatile Organic Compounds and Cancer, run by Anhui Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bao Chuyang, MD (+86 18555039598, des_mond@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Build predictive diagnosis database (time frame: From July 01,2019 to December 31,2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03967652, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019.