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

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 Overview

• Status: Recruiting
• Conditions: Neoplasia

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Ya-Qin Wang, MD PhD; Phone Number: 86 15274810930; Email: wdove.bb@163.com
• Study Contact Backup: Name: Chang-Qing Gao, MD PhD; Phone Number: 86 188 7486 9488; Email: cgao851@126.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • Recruiting
      • Center for Scientific Research with Animal Models, CSU
      • Contact: Ya-Qin Wang, MD PhD; Phone Number: 152 7481 0930; Email: wdove.bb@163.com
      • Contact: Chang-Qing Gao, MD PhD; Phone Number: 86 188 7486 9488; Email: cgao851@126.com
      • Principal Investigator: Chang-Qing Gao, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chang-Qing Gao
• Investigators: Principal Investigator: Chang-Qing Gao, MD PhD, Central South University

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 26, 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: cancer; tumor
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: Xiang-Ya 0003; XY 0003