Transcutaneous Submandibular Gland Biopsy: Feasibility of Repeat Biopsy as a Progression Marker for Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Transcutaneous Submandibular Gland Biopsy: Feasibility of Repeat Biopsy as a Progression Marker for Parkinson&Apos;s Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03359226
• Other study ID #: 17-007240
• Status: Completed
• Phase: N/A
• Start date: November 21, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: November 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion criteria

1. PD patients ages up to age 85.

2. Previous participation in a SMG biopsy study at Mayo Clinic Arizona with a positive biopsy being reported

Exclusion criteria

1. Evidence for dementia that would preclude the patient from signing informed consent

2. History of bleeding diathesis or hematologic disorders

3. Medically unable to undergo a core needle biopsy of the submandibular gland

4. Prior treatment of the submandibular gland with botulinum toxin injections.

5. History of past or current acute infection or abscess of the submandibular gland.

6. History of past or current neoplastic process within the submandibular gland.

7. History of peripheral neuropathy.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Procedure:
• Submandibular gland biopsy
Needle biopsies of the right and left submandibular glands

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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