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The Suitability of Sniff Dog as a Tool in Screening Tumors

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:
NCT02049645
First received: January 25, 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 screening cancer patients in health examination. Trained dogs will sniff serum from participants who are attending the annual health examination to identify potential or high risk subjects, and the results will be compared with the outcome of the traditional health examination, and the high risk subjects will be followed periodically for at least five years.


Condition
Neoplasia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Suitability of Sniff Dog as a Tool in Screening Tumors-- a Prospective Observational Study

Resource links provided by NLM:


Further study details as provided by Central South University:

Primary Outcome Measures:
  • Sensitivity and specificity in screening cancer patients [ Time Frame: up to 5 years ] [ 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 or the currently used methods as non-cancer subjects or at the end of the study, 5 years later still without cancer.


Secondary Outcome Measures:
  • Behavior patterns of sniff dogs to different diseases [ Time Frame: up to 5 years ] [ 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 by the sniff dogs to identifying tumors [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    GCMS etc will be used to compare the volatile compounds between the sera from cancers patients and the from normal subjects, the suspected VOCs will be tested by the dog for conformation.


Biospecimen Retention:   Samples Without DNA

serum


Estimated Enrollment: 4000
Study Start Date: January 2014
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
faculty staff and their adult family members
faculties and their adult family members of the Third Xiang-Ya Hospital

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The Third Xiang-Ya Hospital staff members and their adult family members who wish to participate the study.

Criteria

Inclusion Criteria:

  • old than 20 years
  • currently without cancer diagnosed with pathological examination
  • allow the study team to examine his/her case history and incoming record

Exclusion Criteria:

  • cancer patients with pathological diagnosis
  • who does not allow the study team to examine his/her case history and incoming record
  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: NCT02049645

Contacts
Contact: Chang-Qing Gao, MD PhD 86 13974981039 cgao851@126.com
Contact: Ya-Qin Wang, MD PhD 86 15274810930 wdove.bb@163.com

Locations
China, Hunan
The Third Xiang-Ya Hospital Recruiting
Changsha, Hunan, China, 410013
Contact: Chang-Qing Gao, MD PhD    86 139 7498 1039    cgao851@126.com   
Contact: Ya-Qin Wang, MD PhD    152 7481 0930    wdove.bb@163.com   
Sponsors and Collaborators
Chang-Qing Gao
Investigators
Principal Investigator: Chang-Qing Gao, MD PhD Central South University