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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Central South University
Sponsor:
Information provided by (Responsible Party):
Chang-Qing Gao, Central South University
ClinicalTrials.gov Identifier:
NCT02049658
First received: January 26, 2014
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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
Neoplasia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Sensitivity and Specificity of Sniff Dog as a Tool in Diagnosing the Suspected Tumor Patients

Resource links provided by NLM:


Further study details as provided by Central South University:

Primary Outcome Measures:
  • sensitivity and specificity of the sniff dogs as a tool in diagnosing tumors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • behavior patterns of the sniff dogs to different diseases [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • the substances used for identifying tumors by the sniff dogs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Serum


Estimated Enrollment: 2000
Study Start Date: January 2014
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02049658

Contacts
Contact: Chang-Qing Gao, MD PhD 86 188 7486 9488 cgao851@126.com
Contact: Ya-Qin Wang, MD PhD 86 15274810930 wdove.bb@163.com

Locations
China, Hunan
Center for Scientific Research with Animal Models, CSU Recruiting
Changsha, Hunan, China, 410008
Contact: Chang-Qing Gao, MD PhD    86 188 7486 9488    cgao851@126.com   
Contact: Ya-Qin Wang, MD PhD    152 7481 0930    wdove.bb@163.com   
Principal Investigator: Chang-Qing Gao, MD PhD         
Sponsors and Collaborators
Chang-Qing Gao
Investigators
Principal Investigator: Chang-Qing Gao, MD PhD Central South University
  More Information

No publications provided

Responsible Party: Chang-Qing Gao, MD PhD, Central South University
ClinicalTrials.gov Identifier: NCT02049658     History of Changes
Other Study ID Numbers: Xiang-Ya 0003, XY 0003
Study First Received: January 26, 2014
Last Updated: January 28, 2014
Health Authority: China: Ministry of Health

Keywords provided by Central South University:
tumor
cancer

ClinicalTrials.gov processed this record on October 30, 2014