- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02049645
The Suitability of Sniff Dog as a Tool in Screening Tumors
February 6, 2024 updated by: Chang-Qing Gao
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
4000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chang-Qing Gao, MD PhD
- Phone Number: 86 13974981039
- Email: cgao851@126.com
Study Contact Backup
- Name: Ya-Qin Wang, MD PhD
- Phone Number: 86 15274810930
- Email: wdove.bb@163.com
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410013
- Recruiting
- The Third Xiang-Ya Hospital
-
Contact:
- Chang-Qing Gao, MD PhD
- Phone Number: 86 139 7498 1039
- Email: cgao851@126.com
-
Contact:
- Ya-Qin Wang, MD PhD
- Phone Number: 152 7481 0930
- Email: wdove.bb@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The Third Xiang-Ya Hospital staff members and their adult family members who wish to participate the study.
Description
Inclusion Criteria:
- old than 20 years
- currently without cancer diagnosed with pathological examination
- allow the study team to examine his/her case history and incoming record
Exclusion Criteria:
- cancer patients with pathological diagnosis
- who does not allow the study team to examine his/her case history and incoming record
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
faculty staff and their adult family members
faculties and their adult family members of the Third Xiang-Ya Hospital
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavior patterns of sniff dogs to different diseases
Time Frame: up to 5 years
|
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.
|
up to 5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The substances used by the sniff dogs to identifying tumors
Time Frame: up to 5 years
|
GCMS etc will be used to compare the volatile compounds between the sera from cancers patients and the from normal subjects, the suspected VOCs will be tested by the dog for conformation.
|
up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chang-Qing Gao, MD PhD, Central South University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Willis 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.
- Church 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.
- McCulloch 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.
- Horvath 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
March 1, 2026
Study Registration Dates
First Submitted
January 25, 2014
First Submitted That Met QC Criteria
January 28, 2014
First Posted (Estimated)
January 30, 2014
Study Record Updates
Last Update Posted (Actual)
February 8, 2024
Last Update Submitted That Met QC Criteria
February 6, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Xiang-Ya 0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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