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

NCT02049658 | Recruiting

• 2 other identifiers: Xiang-Ya 0003XY 0003
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neoplasia

Keywords

tumor; cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• behavior patterns of the sniff dogs to different diseases

  12 months

Other Outcomes (1)

• the substances used for identifying tumors by the sniff dogs

  12 months

Study Arms (5)

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

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients who have had pathological results

Sponsors & Collaborators

• Chang-Qing Gao: lead

Study Sites (1)

Center for Scientific Research with Animal Models, CSU

Changsha, Hunan, 410008, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Neoplasms

Study Officials

• Chang-Qing Gao, MD PhD

  Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang-Qing Gao, MD PhD

CONTACT

86 188 7486 9488; cgao851@126.com

Ya-Qin Wang, MD PhD

CONTACT

86 15274810930; wdove.bb@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: January 26, 2014
• First Posted: January 30, 2014
• Study Start: January 1, 2014
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

CN (1)