Transcutaneous Submandibular Gland Biopsy: Feasibility of Repeat Biopsy as a Progression Marker for Parkinson's Disease
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 17-007240
NCT ID: NCT03359226
Sponsor Protocol Number: 17-007240
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Charles Adler, M.D., Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available