NCT02049645

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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

11 years

First QC Date

January 25, 2014

Last Update Submit

February 6, 2024

Conditions

Keywords

lung cancerbreast cancer

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity in screening cancer patients

    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.

    up to 5 years

Secondary Outcomes (1)

  • Behavior patterns of sniff dogs to different diseases

    up to 5 years

Other Outcomes (1)

  • The substances used by the sniff dogs to identifying tumors

    up to 5 years

Study Arms (1)

faculty staff and their adult family members

faculties and their adult family members of the Third Xiang-Ya Hospital

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Xiang-Ya Hospital

Changsha, Hunan, 410013, China

RECRUITING

Related Publications (5)

  • Ehmann R, Boedeker E, Friedrich U, Sagert J, Dippon J, Friedel G, Walles T. Canine scent detection in the diagnosis of lung cancer: revisiting a puzzling phenomenon. Eur Respir J. 2012 Mar;39(3):669-76. doi: 10.1183/09031936.00051711. Epub 2011 Aug 18.

    PMID: 21852337BACKGROUND
  • Church J, Williams H. Another sniffer dog for the clinic? Lancet. 2001 Sep 15;358(9285):930. doi: 10.1016/S0140-6736(01)06065-2. No abstract available.

    PMID: 11575380BACKGROUND
  • Willis CM, Church SM, Guest CM, Cook WA, McCarthy N, Bransbury AJ, Church MR, Church JC. Olfactory detection of human bladder cancer by dogs: proof of principle study. BMJ. 2004 Sep 25;329(7468):712. doi: 10.1136/bmj.329.7468.712.

    PMID: 15388612BACKGROUND
  • McCulloch M, Jezierski T, Broffman M, Hubbard A, Turner K, Janecki T. Diagnostic accuracy of canine scent detection in early- and late-stage lung and breast cancers. Integr Cancer Ther. 2006 Mar;5(1):30-9. doi: 10.1177/1534735405285096.

    PMID: 16484712BACKGROUND
  • Horvath G, Jarverud GA, Jarverud S, Horvath I. Human ovarian carcinomas detected by specific odor. Integr Cancer Ther. 2008 Jun;7(2):76-80. doi: 10.1177/1534735408319058. Epub 2008 May 27.

    PMID: 18505901BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

NeoplasmsLung NeoplasmsBreast Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Chang-Qing Gao, MD PhD

    Central South University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang-Qing Gao, MD PhD

CONTACT

Ya-Qin Wang, MD PhD

CONTACT

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 25, 2014

First Posted

January 30, 2014

Study Start

January 1, 2014

Primary Completion

December 31, 2024

Study Completion

March 1, 2026

Last Updated

February 8, 2024

Record last verified: 2024-02

Locations