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

Sponsor
Chang-Qing Gao (Other)
Overall Status
Recruiting
CT.gov ID
NCT02049658
Collaborator
(none)
2,000
1
119
16.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Sensitivity and Specificity of Sniff Dog as a Tool in Diagnosing the Suspected Tumor Patients
    Study Start Date :
    Jan 1, 2014
    Anticipated Primary Completion Date :
    Dec 31, 2021
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. sensitivity and specificity of the sniff dogs as a tool in diagnosing tumors [12 months]

      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.

    Secondary Outcome Measures

    1. behavior patterns of the sniff dogs to different diseases [12 months]

      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.

    Other Outcome Measures

    1. the substances used for identifying tumors by the sniff dogs [12 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center for Scientific Research with Animal Models, CSU Changsha Hunan China 410008

    Sponsors and Collaborators

    • Chang-Qing Gao

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chang-Qing Gao, MD PhD, Central South University
    ClinicalTrials.gov Identifier:
    NCT02049658
    Other Study ID Numbers:
    • Xiang-Ya 0003
    • XY 0003
    First Posted:
    Jan 30, 2014
    Last Update Posted:
    Oct 29, 2020
    Last Verified:
    Oct 1, 2020
    Keywords provided by Chang-Qing Gao, MD PhD, Central South University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 29, 2020