NeoplasiaNCT02049645
The Suitability of Sniff Dog as a Tool in Screening Tumors
An observational study of Neoplasia, run by Chang-Qing Gao at 1 site in China.
Trial summary
Previous studies have demonstrated that sniff dogs can identify cancer patients from healthy subjects through sniffing exhaled breath air or blood or serum or urine or feces. It is hypothesized that sniff dogs may be used as a tool in screening cancer patients in health examination. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neoplasia
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Mar 2026
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The Third Xiang-Ya Hospital staff members and their adult family members who wish to participate the study.
Who may be able to join
- old than 20 years
- currently without cancer diagnosed with pathological examination
- allow the study team to examine his/her case history and incoming record
Who cannot join
- cancer patients with pathological diagnosis
- who does not allow the study team to examine his/her case history and incoming record
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Xiang-Ya Hospital
Changsha, Hunan, 410013
Chang-Qing Gao, MD PhD, 86 139 7498 1039, cgao851@126.com
Ya-Qin Wang, MD PhD, 152 7481 0930, wdove.bb@163.com
About this study
Official title: The Suitability of Sniff Dog as a Tool in Screening Tumors-- a Prospective Observational Study
Previous studies have demonstrated that sniff dogs can identify cancer patients from healthy subjects through sniffing exhaled breath air or blood or serum or urine or feces. It is hypothesized that sniff dogs may be used as a tool in screening cancer patients in health examination. Trained dogs will sniff serum from participants who are attending the annual health examination to identify potential or high risk subjects, and the results will be compared with the outcome of the traditional health examination, and the high risk subjects will be followed periodically for at least five years.
- Conditions
- Neoplasia
- Keywords
- lung cancer, breast cancer
- Medical subject headings
- Neoplasms, Lung Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| faculty staff and their adult family members | faculties and their adult family members of the Third Xiang-Ya Hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity in screening cancer patients
The results that obtained from the dogs will be compared with these of the pathological examinations. Sensitivity = the No. of patients identified by the dogs as cancers / the No. of patients suffering from cancer confirmed by pathological examination. Specificity = No. of subjects signaled by the dog as non-cancers / No. of subjects confirmed by pathological examination or the currently used methods as non-cancer subjects or at the end of the study, 5 years later still without cancer.
Measured: up to 5 years
Secondary outcomes (1)
Behavior patterns of sniff dogs to different diseases
The behavior (lying before the tank for positive, neglecting the tanks) of the dog will be recorded and compared with the results of the pathological examination.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startJan 2014
- Primary completion31 Dec 2024 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for NeoplasiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang-Qing Gao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chang-Qing Gao, Central South University
- Investigators
- Chang-Qing Gao, MD PhD, Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049645
- Sponsor's protocol ID
- Xiang-Ya 0001
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2014
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ehmann R, Boedeker E, Friedrich U, Sagert J, Dippon J, Friedel G, Walles T. Canine scent detection in the diagnosis of lung cancer: revisiting a puzzling phenomenon. Eur Respir J. 2012 Mar;39(3):669-76. doi: 10.1183/09031936.00051711. Epub 2011 Aug 18.
PubMed 21852337Church J, Williams H. Another sniffer dog for the clinic? Lancet. 2001 Sep 15;358(9285):930. doi: 10.1016/S0140-6736(01)06065-2. No abstract available.
PubMed 11575380Willis CM, Church SM, Guest CM, Cook WA, McCarthy N, Bransbury AJ, Church MR, Church JC. Olfactory detection of human bladder cancer by dogs: proof of principle study. BMJ. 2004 Sep 25;329(7468):712. doi: 10.1136/bmj.329.7468.712.
PubMed 15388612McCulloch M, Jezierski T, Broffman M, Hubbard A, Turner K, Janecki T. Diagnostic accuracy of canine scent detection in early- and late-stage lung and breast cancers. Integr Cancer Ther. 2006 Mar;5(1):30-9. doi: 10.1177/1534735405285096.
PubMed 16484712Horvath G, Jarverud GA, Jarverud S, Horvath I. Human ovarian carcinomas detected by specific odor. Integr Cancer Ther. 2008 Jun;7(2):76-80. doi: 10.1177/1534735408319058. Epub 2008 May 27.
PubMed 18505901
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Suitability of Sniff Dog as a Tool in Screening Tumors-- a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02049645
- Acronym / sponsor ID
- Xiang-Ya 0001
- Conditions
- Neoplasia
- Keywords
- lung cancer, breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Chang-Qing GaoUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 30 Jan 2014 (estimated)
- 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.
Previous studies have demonstrated that sniff dogs can identify cancer patients from healthy subjects through sniffing exhaled breath air or blood or serum or urine or feces. It is hypothesized that sniff dogs may be used as a tool in screening cancer patients in health examination. Trained dogs will sniff serum from participants who are attending the annual health examination to identify potential or high risk subjects, and the results will be compared with the outcome of the traditional health examination, and the high risk subjects will be followed periodically for at least five years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| faculty staff and their adult family members | – | –faculties and their adult family members of the Third Xiang-Ya Hospital |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The Third Xiang-Ya Hospital staff members and their adult family members who wish to participate the study.
Key inclusion criteria (3 listed)
- old than 20 years
- currently without cancer diagnosed with pathological examination
- allow the study team to examine his/her case history and incoming record
Key exclusion criteria (2 listed)
- cancer patients with pathological diagnosis
- who does not allow the study team to examine his/her case history and incoming record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and specificity in screening cancer patients
Time frame: up to 5 years
The results that obtained from the dogs will be compared with these of the pathological examinations. Sensitivity = the No. of patients identified by the dogs as cancers / the No. of patients suffering from cancer confirmed by pathological examination. Specificity = No. of subjects signaled by the dog as non-cancers / No. of subjects confirmed by pathological examination or the currently used methods as non-cancer subjects or at the end of the study, 5 years later still without cancer.
1 secondary outcome
Behavior patterns of sniff dogs to different diseases
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Background: PubMed 21852337Ehmann R, Boedeker E, Friedrich U, Sagert J, Dippon J, Friedel G, Walles T. Canine scent detection in the diagnosis of lung cancer: revisiting a puzzling phenomenon. Eur Respir J. 2012 Mar;39(3):669-76. doi: 10.1183/09031936.00051711. Epub 2011 Aug 18.
- Background: PubMed 11575380Church J, Williams H. Another sniffer dog for the clinic? Lancet. 2001 Sep 15;358(9285):930. doi: 10.1016/S0140-6736(01)06065-2. No abstract available.
- Background: PubMed 15388612Willis CM, Church SM, Guest CM, Cook WA, McCarthy N, Bransbury AJ, Church MR, Church JC. Olfactory detection of human bladder cancer by dogs: proof of principle study. BMJ. 2004 Sep 25;329(7468):712. doi: 10.1136/bmj.329.7468.712.
- Background: PubMed 16484712McCulloch M, Jezierski T, Broffman M, Hubbard A, Turner K, Janecki T. Diagnostic accuracy of canine scent detection in early- and late-stage lung and breast cancers. Integr Cancer Ther. 2006 Mar;5(1):30-9. doi: 10.1177/1534735405285096.
- Background: PubMed 18505901Horvath G, Jarverud GA, Jarverud S, Horvath I. Human ovarian carcinomas detected by specific odor. Integr Cancer Ther. 2008 Jun;7(2):76-80. doi: 10.1177/1534735408319058. Epub 2008 May 27.
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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.
Chang-Qing Gao, MD PhD principal investigator
Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasia, run by Chang-Qing Gao at 1 site in China.
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 2 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 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Chang-Qing Gao, MD PhD (86 13974981039, cgao851@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity in screening cancer patients (time frame: up to 5 years). 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 NCT02049645, which also lists 5 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 8 Feb 2024.