The Sensitivity and Specificity of Canine Detection of Parkinson's Disease

• ClinicalTrials.gov Identifier: NCT04613531
• Recruitment Status: Completed
• First Posted: November 3, 2020
• Last Update Posted: September 27, 2021
• Sponsor: Central South University
• Collaborators: University of South China; Mingji Hospital
• Information provided by (Responsible Party): Chang-Qing Gao, Central South University

Tracking Information

• First Submitted Date: October 28, 2020
• First Posted Date: November 3, 2020
• Last Update Posted Date: September 27, 2021
• Actual Study Start Date: November 1, 2020
• Actual Primary Completion Date: January 22, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 21, 2021)

The specificity and sensitivity of the identification of PD patients from non-PD by at least 2 out of 3 sniffer dogs [ Time Frame: Samples taken at the time of participant enrolment and assessed by the sniffer dogs within 20 weeks ]

Sensitivity = number of samples of PD patients that were correctly identified by dogs/[number of samples of PD patients that were correctly identified+ number of samples of PD patients missed by the dogs]. One sample will be taken per patient. Specificity = number of samples of non-PD subjects that were correctly identified by dogs/[number of samples of non-PD subjects that were correctly identified by dogs + number of non-PD subjects that were identified as PD]. One sample will be taken per subject.

Original Primary Outcome Measures (submitted: October 28, 2020)

The specificity and sensitivity of the identification of PD patients from non-PD by sniffer dogs [ Time Frame: study is expected to be finished within 2 months ]

sensitivity = number of identified as PD by dogs/number of PD diagnosed by doctors;specificity = number of participants identified by sniffer dogs as no PD/number of participants diagnosed by doctors as non-PD

Current Secondary Outcome Measures (submitted: September 21, 2021)

Assess the accuracy of identification by sniffer dogs for PD patients with disease duration over five years and for those with disease duration within five years of diagnosis. [ Time Frame: Samples taken at the time of participant enrolment and assessed by the sniffer dogs within 20 weeks ]

Calculate sensitivity and specificity as mentioned above, but in two sub-populations: 1. PD patients with disease duration within 5 years and their control subjects; 2. PD patients with disease duration over 5 years and their control subjects.

Original Secondary Outcome Measures (submitted: October 28, 2020)

Test whether PD patients have different smell compared to MSA ,PSP and other neurodegenration diseases [ Time Frame: study is expected to be finished within 2 months ]

Test whether PD patients can be identified from MSA, PSP and other neurodegeneration diseases by sniffer dogs

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Sensitivity and Specificity of Canine Detection of Parkinson's Disease
• Official Title: The Sensitivity and Specificity of Sniffer Dogs for Diagnosis of Parkinson's Disease: Diagnostic Accuracy Study
• Brief Summary: People sometimes report that their relatives who have been diagnosed with Parkinson's disease (PD) have a unique smell. A previous study has demonstrated that PD patients do have smell that is different from that of healthy people. Sniffer dogs have long been used to identify criminals, and recently been used to identify subject with cancer. The investigators hypothesized that sniffer dogs may be able to identify PD patients.

Detailed Description

Parkinson's Disease is a neurodegeneration disorder that affects the life of millions of people worldwide. There are multiple drugs available now that can modify the process of the disease. Making a timely and correct diagnosis of PD is still a great challenge in many cases even for specialists. Correct diagnosis is fundamental to the appropriate administration of medicines. To help clinicians to quickly and correctly make a diagnosis, the investigators aim to use sniffer dogs to identify PD patients from clearly non-PD subjects. After more than one-year training of the dogs, the investigators found that it is feasible to use dogs to identify PD patients from non-PD subjects. Now the investigators are trying to estimate the sensitivity and specificity of sniffer dogs in identifying PD patients from non-PD subjects.

In this multicenter study, the clinicians and their assistants will collect samples and send to the study center. One researcher alone will put seven plastic bags containing matched samples (one PD sample and six non-PD samples) on a table and take notes, then relabel them with random numbers and take notes again, and keep them in a confidential place till the study is completed. Another researcher will take over the relabeled samples and put them into different tanks and take notes. Thus, both the experimenter who helps to place the samples into tanks and the dog handler will not know the nature of the samples. Test results will be compared with the notes of the blind-setter after all the experiments have been performed. The sensitivity and specificity of identification will be calculated. The study aims to test the hypothesis that the diagnostic sensitivity of sniffer dogs in identifying PD patients from non-PD subjects is over 90%.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years

Biospecimen

Retention:   Samples Without DNA

Description:

smell from participants' upper back

• Sampling Method: Non-Probability Sample
• Study Population: PD patients and other subjects in clinics
• Condition: Parkinson Disease
• Intervention: Not Provided

Study Groups/Cohorts

• Participants with PD
  patients with clinically diagnosed Parkinson's disease
• Participants without PD
  participants clinically diagnosed without Parkinsons' Disease

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 12, 2021): 1198
• Original Estimated Enrollment (submitted: October 28, 2020): 300
• Actual Study Completion Date: January 22, 2021
• Actual Primary Completion Date: January 22, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Clinically established PD patients
• Clearly non-PD subjects will be recruited as controls

Exclusion Criteria:

• subjects with tremor or decrease of olfactory power or with rapid eye movement sleep behavior, obvious constipation, and depression.
• subjects who are taking antipsychotics.
• subjects with incomplete data.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04613531
• Other Study ID Numbers: Xiang Ya 0005
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Chang-Qing Gao, Central South University
• Original Responsible Party: Chang-Qing Gao, Central South University, MD PhD
• Current Study Sponsor: Central South University
• Original Study Sponsor: Same as current

Collaborators

• University of South China
• Mingji Hospital

Investigators

• Study Director: Chang-Qing Gao, MD,PhD; Xiang-Ya Hospital, Central South University

• PRS Account: Central South University
• Verification Date: September 2021