The Sensitivity and Specificity of Sniff Dog as a Tool in Diagnosing the Suspected Tumor Patients

Neoplasia Clinical Trial

Official title:

The Sensitivity and Specificity of Sniff Dog as a Tool in Diagnosing the Suspected Tumor Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02049658
• Other study ID #: Xiang-Ya 0003
• Secondary ID: XY 0003
• Status: Recruiting
• Start date: January 2014
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Central South University
• Contact: Chang-Qing Gao, MD PhD
• Phone: 86 188 7486 9488
• Email: cgao851[@]126.com
• Is FDA regulated: No
• 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients who have had pathological results

Related Conditions & MeSH terms

• Neoplasia
• Neoplasms

Locations

Country	Name	City	State
China	Center for Scientific Research with Animal Models, CSU	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Chang-Qing Gao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the substances used for identifying tumors by the sniff dogs	GCMS etc will be used to compare the volatile compounds between the sera from cancers patients and the from non-cancer subjects, the suspected VOCs will be tested by the dog for conformation.	12 months
Primary	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.	12 months
Secondary	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.	12 months