Parkinson DiseaseNCT04613531
The Sensitivity and Specificity of Canine Detection of Parkinson's Disease
An observational study of Parkinson Disease, run by Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- How many people
- 1,198 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 22 Jan 2021
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: PD patients and other subjects in clinics
Who may be able to join
- Clinically established PD patients
- Clearly non-PD subjects will be recruited as controls
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Sensitivity and Specificity of Sniffer Dogs for Diagnosis of Parkinson's Disease: Diagnostic Accuracy Study
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.
Read the 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%.
- Conditions
- Parkinson Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with PD | patients with clinically diagnosed Parkinson's disease | |
| Participants without PD | participants clinically diagnosed without Parkinsons' Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
The specificity and sensitivity of the identification of PD patients from non-PD by at least 2 out of 3 sniffer dogs
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.
Measured: Samples taken at the time of participant enrolment and assessed by the sniffer dogs within 20 weeks
Secondary outcomes (1)
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.
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.
Measured: Samples taken at the time of participant enrolment and assessed by the sniffer dogs within 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Nov 2020
- Primary completion22 Jan 2021
- Study completion22 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,198 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- University of South China, Mingji Hospital
- Responsible party
- Principal investigator, Chang-Qing Gao, Central South University
- Investigators
- Chang-Qing Gao, MD,PhD, Study director, Xiang-Ya Hospital, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613531
- Sponsor's protocol ID
- Xiang Ya 0005
- Status last verified
- Sep 2021
- First submitted
- 28 Oct 2020
- Last updated
- 27 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sensitivity and Specificity of Sniffer Dogs for Diagnosis of Parkinson's Disease: Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT04613531
- Acronym / sponsor ID
- Xiang Ya 0005
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,198 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Collaborators
- University of South China, Mingji Hospital
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 22 Jan 2021 (actual)
- Study completion
- 22 Jan 2021 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with PD | – | –patients with clinically diagnosed Parkinson's disease |
| Participants without PD | – | –participants clinically diagnosed without Parkinsons' Disease |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- PD patients and other subjects in clinics
Key inclusion criteria (2 listed)
- Clinically established PD patients
- Clearly non-PD subjects will be recruited as controls
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang-Qing Gao, MD,PhD study director
Xiang-Ya Hospital, Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.