Back to resultsTranscutaneous Submandibular Gland Biopsy: Feasibility of Repeat Biopsy as a Progression Marker for Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Submandibular gland biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Parkinson Disease
Eligibility Criteria
Inclusion criteria
- PD patients ages up to age 85.
- Previous participation in a SMG biopsy study at Mayo Clinic Arizona with a positive biopsy being reported
Exclusion criteria
- 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.
Sites / Locations
- Mayo Clinic in Arizona
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Submandibular gland biopsy
Arm Description
No treatment is being used in this study. Study participants will have bilateral submandibular gland biopsies.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03359226
Brief Title
Transcutaneous Submandibular Gland Biopsy: Feasibility of Repeat Biopsy as a Progression Marker for Parkinson's Disease
Official Title
Transcutaneous Submandibular Gland Biopsy: Feasibility of Repeat Biopsy as a Progression Marker for Parkinson&Apos;s Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Tissue biopsies documenting the presence and density of Lewy type synucleinopathy (LTS) in living patients with probable Parkinsons disease (PD) would be extremely valuable as a diagnostic test, as a marker of molecular therapeutic target engagement and as a progression marker. Based on recent data from our group with both early and advanced PD patients, we propose to perform a second transcutaneous submandibular gland (SMG) needle core biopsy in 12 patients who have previously been biopsied and had LTS present in their SMG tissue.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Submandibular gland biopsy
Arm Type
Experimental
Arm Description
No treatment is being used in this study. Study participants will have bilateral submandibular gland biopsies.
Intervention Type
Procedure
Intervention Name(s)
Submandibular gland biopsy
Intervention Description
Needle biopsies of the right and left submandibular glands
Primary Outcome Measure Information:
Title
Presence of alpha-synuclein in the submandibular gland
Description
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.
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
PD patients ages up to age 85.
Previous participation in a SMG biopsy study at Mayo Clinic Arizona with a positive biopsy being reported
Exclusion criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles H Adler
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Transcutaneous Submandibular Gland Biopsy: Feasibility of Repeat Biopsy as a Progression Marker for Parkinson's Disease
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