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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02049645
Other study ID # Xiang-Ya 0001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2014
Est. completion date March 2026

Study information

Verified date February 2024
Source Central South University
Contact Chang-Qing Gao, MD PhD
Phone 86 13974981039
Email cgao851@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 4000
Est. completion date March 2026
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
China The Third Xiang-Ya Hospital Changsha Hunan

Sponsors (1)

Lead Sponsor Collaborator
Chang-Qing Gao

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other The substances used by the sniff dogs to identifying tumors 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
Primary 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. up to 5 years
Secondary 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. up to 5 years
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