Parkinson DiseaseNCT04264273
Diagnosis of Parkinson´s Disease by Means of Submandibular Gland Needle Biopsy
An observational study of Parkinson Disease, run by Universität des Saarlandes at 1 site in Germany.
Trial summary
This study includes 35 PD patients who underwent submandibular gland needle biopsy. 25 neurologically healthy patients of the local otolaryngological clinic, in whom submandibular gland needle biopsy was performed due to a clinical indication, serve as controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 7 Feb 2020to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Unselected cohort of PD patients
Who may be able to join
None listed.
Who cannot join
- Missing consent to participation in the study
- Pregnancy
- Indigestibility against local anesthetic
- Increased risk of bleeding
- Therapy with an anticoagulant
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurology, Saarland University
Homburg/Saar, Saarland, D-66421
Joerg Spiegel, MD, 49-6841-1624101, nejspi@uniklinik-saarland.de
Walter Schulz-Schaeffer, MD, 49-6841-1623865, Walter.Schulz-Schaeffer@uks.eu
About this study
Official title: Intra Vitam Diagnosis of Parkinson´s Disease by Means of Submandibular Gland Needle Biopsy
This study includes 35 PD patients who underwent submandibular gland needle biopsy. 25 neurologically healthy patients of the local otolaryngological clinic, in whom submandibular gland needle biopsy was performed due to a clinical indication, serve as controls.
Read the detailed description
Parkinson´s disease (PD) is a neurodegenerative disease which is characterized by a pathological aggregation of α-synuclein. This pathological α-synuclein aggregation results in the formation of Lewy bodies which are used for the histopathological diagnosis of PD. Neuropathological post mortem studies showed that pathological aggregations of α-synuclein may occur also outside the central nervous system in PD, for example in the cardiac plexus, in the major salivary glands and the innervating cervical superior ganglion, in the minor salivary glands, in the adrenal glands and in the mesenteric and pelvic plexus. The finding of pathologically aggregated α-synuclein in the major salivary glands offers the possibility to prove PD intra vitam by means of a small transcutaneous biopsy.
A recent post mortem study in the local Department of Neuropathology found, that there was pathologically aggregated α-synuclein in 12 of 14 patients with diagnosed and neuropathologically confirmed PD, whereas there was no pathologically aggregated α-synuclein in 13 persons without PD.
The present study includes 35 PD patients who underwent submandibular gland needle biopsy. 25 neurologically healthy patients of the local otolaryngological clinic, in whom submandibular gland needle biopsy was performed due to a clinical indication, serve as controls. Immediately after the biopsy, the obtained submandibular gland tissue is transported to the local Department of Neuropathology for histopathological analysis.
- Conditions
- Parkinson Disease
- Keywords
- Alpha synuclein
- Medical subject headings
- Parkinson Disease, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Parkinson´s disease. | Participants who fulfilled the diagnostic criteria of Parkinson´s disease. | |
| Participants without a neurological disease | 25 neurologically healthy patients of the local otolaryngological clinic, in whom submandibular gland needle biopsy was performed due to a clinical indication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologically aggregated α-synuclein in the submandibular gland.
The biopsy was taken with a biopsy needle (diameter 14 g) which was inserted under sonographic control into one of the both submandibular glands. By means of this biopsy method, a biopsy cylinder was obtained from one submandibular gland. The biopsy cylinder which was immediately transported to the Department of Neuropathology. The whole biopsy cylinder was histopathologically investigated for pathologically aggregated alpha-synuclein. Two histopathological results are possible: presence of at least one pathologically aggregated alpha-synuclein in the obtained biopsy cylinder (positive result) or absence of any pathologically aggregated alpha-synuclein in the obtained biopsy cylinder (negative result).
Measured: only baseline, no further investigations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start7 Feb 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joerg Spiegel, Universität des Saarlandes
- Investigators
- Jörg Spiegel, MD, Principal investigator, Department of Neurology, Saarland University, D-66421 Homburg/Saar, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264273
- Sponsor's protocol ID
- 234/19
- Status last verified
- Feb 2020
- First submitted
- 27 Jan 2020
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deidentified individual participant data for all measures will be made available.
Publications
Adler CH, Dugger BN, Hentz JG, Hinni ML, Lott DG, Driver-Dunckley E, Mehta S, Serrano G, Sue LI, Duffy A, Intorcia A, Filon J, Pullen J, Walker DG, Beach TG. Peripheral Synucleinopathy in Early Parkinson's Disease: Submandibular Gland Needle Biopsy Findings. Mov Disord. 2016 Feb;31(2):250-6. doi: 10.1002/mds.26476. Epub 2016 Jan 22.
PubMed 26799362Beach TG, Adler CH, Dugger BN, Serrano G, Hidalgo J, Henry-Watson J, Shill HA, Sue LI, Sabbagh MN, Akiyama H; Arizona Parkinson's Disease Consortium. Submandibular gland biopsy for the diagnosis of Parkinson disease. J Neuropathol Exp Neurol. 2013 Feb;72(2):130-6. doi: 10.1097/NEN.0b013e3182805c72.
PubMed 23334596Del Tredici K, Hawkes CH, Ghebremedhin E, Braak H. Lewy pathology in the submandibular gland of individuals with incidental Lewy body disease and sporadic Parkinson's disease. Acta Neuropathol. 2010 Jun;119(6):703-13. doi: 10.1007/s00401-010-0665-2. Epub 2010 Mar 14.
PubMed 20229352Orimo S, Uchihara T, Nakamura A, Mori F, Kakita A, Wakabayashi K, Takahashi H. Axonal alpha-synuclein aggregates herald centripetal degeneration of cardiac sympathetic nerve in Parkinson's disease. Brain. 2008 Mar;131(Pt 3):642-50. doi: 10.1093/brain/awm302. Epub 2007 Dec 13.
PubMed 18079166Spillantini MG, Schmidt ML, Lee VM, Trojanowski JQ, Jakes R, Goedert M. Alpha-synuclein in Lewy bodies. Nature. 1997 Aug 28;388(6645):839-40. doi: 10.1038/42166. No abstract available.
PubMed 9278044
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra Vitam Diagnosis of Parkinson´s Disease by Means of Submandibular Gland Needle Biopsy
- ClinicalTrials.gov ID
- NCT04264273
- Acronym / sponsor ID
- 234/19
- Conditions
- Parkinson Disease
- Keywords
- Alpha synuclein
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study includes 35 PD patients who underwent submandibular gland needle biopsy. 25 neurologically healthy patients of the local otolaryngological clinic, in whom submandibular gland needle biopsy was performed due to a clinical indication, serve as controls.
Detailed description
Parkinson´s disease (PD) is a neurodegenerative disease which is characterized by a pathological aggregation of α-synuclein. This pathological α-synuclein aggregation results in the formation of Lewy bodies which are used for the histopathological diagnosis of PD. Neuropathological post mortem studies showed that pathological aggregations of α-synuclein may occur also outside the central nervous system in PD, for example in the cardiac plexus, in the major salivary glands and the innervating cervical superior ganglion, in the minor salivary glands, in the adrenal glands and in the mesenteric and pelvic plexus. The finding of pathologically aggregated α-synuclein in the major salivary glands offers the possibility to prove PD intra vitam by means of a small transcutaneous biopsy.
A recent post mortem study in the local Department of Neuropathology found, that there was pathologically aggregated α-synuclein in 12 of 14 patients with diagnosed and neuropathologically confirmed PD, whereas there was no pathologically aggregated α-synuclein in 13 persons without PD.
The present study includes 35 PD patients who underwent submandibular gland needle biopsy. 25 neurologically healthy patients of the local otolaryngological clinic, in whom submandibular gland needle biopsy was performed due to a clinical indication, serve as controls. Immediately after the biopsy, the obtained submandibular gland tissue is transported to the local Department of Neuropathology for histopathological analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Parkinson´s disease. | – | –Participants who fulfilled the diagnostic criteria of Parkinson´s disease. |
| Participants without a neurological disease | – | –25 neurologically healthy patients of the local otolaryngological clinic, in whom submandibular gland needle biopsy was performed due to a clinical indication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Unselected cohort of PD patients
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Missing consent to participation in the study
- Pregnancy
- Indigestibility against local anesthetic
- Increased risk of bleeding
- Therapy with an anticoagulant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pathologically aggregated α-synuclein in the submandibular gland.
Time frame: only baseline, no further investigations.
The biopsy was taken with a biopsy needle (diameter 14 g) which was inserted under sonographic control into one of the both submandibular glands. By means of this biopsy method, a biopsy cylinder was obtained from one submandibular gland. The biopsy cylinder which was immediately transported to the Department of Neuropathology. The whole biopsy cylinder was histopathologically investigated for pathologically aggregated alpha-synuclein. Two histopathological results are possible: presence of at least one pathologically aggregated alpha-synuclein in the obtained biopsy cylinder (positive result) or absence of any pathologically aggregated alpha-synuclein in the obtained biopsy cylinder (negative result).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Background: PubMed 26799362Adler CH, Dugger BN, Hentz JG, Hinni ML, Lott DG, Driver-Dunckley E, Mehta S, Serrano G, Sue LI, Duffy A, Intorcia A, Filon J, Pullen J, Walker DG, Beach TG. Peripheral Synucleinopathy in Early Parkinson's Disease: Submandibular Gland Needle Biopsy Findings. Mov Disord. 2016 Feb;31(2):250-6. doi: 10.1002/mds.26476. Epub 2016 Jan 22.
- Background: PubMed 23334596Beach TG, Adler CH, Dugger BN, Serrano G, Hidalgo J, Henry-Watson J, Shill HA, Sue LI, Sabbagh MN, Akiyama H; Arizona Parkinson's Disease Consortium. Submandibular gland biopsy for the diagnosis of Parkinson disease. J Neuropathol Exp Neurol. 2013 Feb;72(2):130-6. doi: 10.1097/NEN.0b013e3182805c72.
- Background: PubMed 20229352Del Tredici K, Hawkes CH, Ghebremedhin E, Braak H. Lewy pathology in the submandibular gland of individuals with incidental Lewy body disease and sporadic Parkinson's disease. Acta Neuropathol. 2010 Jun;119(6):703-13. doi: 10.1007/s00401-010-0665-2. Epub 2010 Mar 14.
- Background: PubMed 18079166Orimo S, Uchihara T, Nakamura A, Mori F, Kakita A, Wakabayashi K, Takahashi H. Axonal alpha-synuclein aggregates herald centripetal degeneration of cardiac sympathetic nerve in Parkinson's disease. Brain. 2008 Mar;131(Pt 3):642-50. doi: 10.1093/brain/awm302. Epub 2007 Dec 13.
- Background: PubMed 9278044Spillantini MG, Schmidt ML, Lee VM, Trojanowski JQ, Jakes R, Goedert M. Alpha-synuclein in Lewy bodies. Nature. 1997 Aug 28;388(6645):839-40. doi: 10.1038/42166. No abstract available.
- Individual participant dataSharing planned: Undecided. Deidentified individual participant data for all measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jörg Spiegel, MD principal investigator
Department of Neurology, Saarland University, D-66421 Homburg/Saar, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Universität des Saarlandes at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jörg Spiegel, MD (+49 6841 1624101, joerg.spiegel@uks.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologically aggregated α-synuclein in the submandibular gland. (time frame: only baseline, no further investigations.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04264273, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.