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Completed

NCT Number: NCT03359226

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Submandibular gland biopsy

Procedure

Needle biopsies of the right and left submandibular glands

Primary outcomes

  1. Presence of alpha-synuclein in the submandibular gland

    Time frame: baseline

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 2, 2017
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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