NeoplasiaNCT02049658
The Sensitivity and Specificity of Sniff Dog as a Tool in Diagnosing the Suspected Tumor Patients
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 identifying cancer patients in the high risk population or suspected patients. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Neoplasia
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: * Healthy volunteers who have been examined by the currently used procedures and find to be without tumors. * Patients in the breast surgery, thoracic surgery, gynecological and neurosurgery departments with lesions with characteristics of tumors
Who may be able to join
- Healthy volunteers who have been examined by the currently used procedures and find to be without tumors.
- Patients in the breast surgery, thoracic surgery, gynecological and neurosurgery departments with lesions with characteristics of tumors
Who cannot join
- Patients who have had pathological results
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Center for Scientific Research with Animal Models, CSU
Changsha, Hunan, 410008
Chang-Qing Gao, MD PhD, 86 188 7486 9488, cgao851@126.com
Ya-Qin Wang, MD PhD, 152 7481 0930, wdove.bb@163.com
About this 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 identifying cancer patients in the high risk population or suspected patients. Trained dogs will sniff serum from participants who are suspected to suffer from tumor by their physicians and not yet but will be diagnosed by pathological examination.The results will be compared with the outcome of the pathological examination.
- Conditions
- Neoplasia
- Keywords
- tumor, cancer
- Medical subject headings
- 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 |
|---|---|---|
| Healthy volunteers | Healthy volunteers measured by currently used healthy screening procedures | |
| Suspected breast cancer subjects | Suspected breast cancer subjects without pathological examination yet but will have it soon | |
| Suspected lung cancer subjects | Suspected lung cancer subjects without pathological examination yet but will have it soon | |
| Suspected neurological tumor subjects | Suspected neurological tumor subjects without pathological examination yet but will have it soon | |
| Suspected patients with gynecological tumor | Suspected subjects with gynecological tumors without pathological examination yet but will have it soon |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity and specificity of the sniff dogs as a tool in diagnosing tumors
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 as non-cancer subjects.
Measured: 12 months
Secondary outcomes (1)
behavior patterns of the 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: 12 months
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 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 2,000 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
- NCT02049658
- Sponsor's protocol ID
- Xiang-Ya 0003
- Other IDs
- XY 0003
- Status last verified
- Feb 2024
- First submitted
- 26 Jan 2014
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
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 Sensitivity and Specificity of Sniff Dog as a Tool in Diagnosing the Suspected Tumor Patients
- ClinicalTrials.gov ID
- NCT02049658
- Acronym / sponsor ID
- Xiang-Ya 0003
- Conditions
- Neoplasia
- Keywords
- tumor, cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Chang-Qing GaoUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- Dec 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 identifying cancer patients in the high risk population or suspected patients. Trained dogs will sniff serum from participants who are suspected to suffer from tumor by their physicians and not yet but will be diagnosed by pathological examination.The results will be compared with the outcome of the pathological examination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | –Healthy volunteers measured by currently used healthy screening procedures |
| Suspected breast cancer subjects | – | –Suspected breast cancer subjects without pathological examination yet but will have it soon |
| Suspected lung cancer subjects | – | –Suspected lung cancer subjects without pathological examination yet but will have it soon |
| Suspected neurological tumor subjects | – | –Suspected neurological tumor subjects without pathological examination yet but will have it soon |
| Suspected patients with gynecological tumor | – | –Suspected subjects with gynecological tumors without pathological examination yet but will have it soon |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Healthy volunteers who have been examined by the currently used procedures and find to be without tumors. * Patients in the breast surgery, thoracic surgery, gynecological and neurosurgery departments with lesions with characteristics of tumors
Key inclusion criteria (2 listed)
- Healthy volunteers who have been examined by the currently used procedures and find to be without tumors.
- Patients in the breast surgery, thoracic surgery, gynecological and neurosurgery departments with lesions with characteristics of tumors
Key exclusion criteria (1 listed)
- Patients who have had pathological results
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 of the sniff dogs as a tool in diagnosing tumors
Time frame: 12 months
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 as non-cancer subjects.
1 secondary outcome
behavior patterns of the sniff dogs to different diseases
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
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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.
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 2 inclusion and 1 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chang-Qing Gao, MD PhD (86 188 7486 9488, 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 of the sniff dogs as a tool in diagnosing tumors (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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; AzTrials last refreshed its copy on 6 Nov 2026.