Transcutaneous Submandibular Gland Biopsy: Feasibility of Repeat Biopsy as a Progression Marker for Parkinson's Disease
1 other identifier
interventional
7
1 country
1
Brief Summary
The purpose of this study is to perform biopsies of one of the glands that make saliva. The biopsied tissue will then be analyzed to see if it has changes that occur in Parkinson's disease. This study will determine whether it is possible to do a second biopsy a few years after a previous biopsy and determine whether there are changes in the biopsy that would allow for analysis of disease progression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable parkinson-disease
Started Nov 2017
Shorter than P25 for not_applicable parkinson-disease
1 active site
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
First Submitted
Initial submission to the registry
November 14, 2017
CompletedStudy Start
First participant enrolled
November 21, 2017
CompletedFirst Posted
Study publicly available on registry
December 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2018
CompletedNovember 6, 2018
November 1, 2018
6 months
November 14, 2017
November 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Presence of alpha-synuclein in the submandibular gland
The biopsied submandibular gland tissue will be stained with an antibody for alpha-synuclein. The pathologist will review the slides and determine the number that show positive staining for neuronal elements. He will compare the number of positive slides between the right and left submandibular glands to see if they are similar.
baseline
Study Arms (1)
Submandibular gland biopsy
EXPERIMENTALNo treatment is being used in this study. Study participants will have bilateral submandibular gland biopsies.
Interventions
Needle biopsies of the right and left submandibular glands
Eligibility Criteria
You may qualify if:
- PD patients ages up to age 85.
- Previous participation in a SMG biopsy study at Mayo Clinic Arizona with a positive biopsy being reported
You may not qualify if:
- Evidence for dementia that would preclude the patient from signing informed consent
- History of bleeding diathesis or hematologic disorders
- Medically unable to undergo a core needle biopsy of the submandibular gland
- Prior treatment of the submandibular gland with botulinum toxin injections.
- History of past or current acute infection or abscess of the submandibular gland.
- History of past or current neoplastic process within the submandibular gland.
- History of peripheral neuropathy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles H Adler
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neurology
Study Record Dates
First Submitted
November 14, 2017
First Posted
December 2, 2017
Study Start
November 21, 2017
Primary Completion
May 31, 2018
Study Completion
May 31, 2018
Last Updated
November 6, 2018
Record last verified: 2018-11