Analysis of the Enteric Nervous System Using Colonic Biopsies

Study Overview
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Brief Summary
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The aim of this project is to develop an original biomarker for Parkinson's disease (PD) and other parkinsonian syndromes (multiple system atrophy and progressive supranuclear palsy) based upon the detection of pathological alpha-synuclein species in routine colonoscopic biopsies.

Official Title
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Analysis of the Enteric Nervous System Using Colonic Biopsies: a Useful Biomarker for the Differential Diagnosis of Parkinsonian Syndromes?

Conditions
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Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy

Intervention / Treatment
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* Procedure: colonoscopy or rectosigmoidoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients Patients aged 50-80 year old, both genders Parkinson's disease patients Multiple system atrophy patients Progressive supranuclear palsy patients Controls: patient at risk of colic cancer for whom a colonoscopy is required Patients who signed the informed consent Controls Patients aged 50 to 80 year-old for whom a rectosigmoidoscopy or a colonoscopy is required for colorectal screening Patients who signed the informed consent Health care beneficiary Exclusion Criteria: Patients Colonic disorder (except non-complicated diverticular disease) Other neurological disorder than parkinsonism Patients treated with either platelet antiaggregants, anticoagulants or with a known coagulation disorder Patients with a cognitive impairment that preclude them from understanding the informed consent Patients placed under legal guardianship Controls Neurodegenerative disorders such as Parkinson's disease, Alzheimer's disease or other dementia, amyotrophic lateral sclerosis... Functional bowel disorder such as irritable bowel syndrome Patients with a cognitive impairment that preclude them from understanding the informed consent

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colonic biopsies<br>Colonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy | Procedure: colonoscopy or rectosigmoidoscopy<br>* Usual procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry | Colonic biopsies are obtained during the course of colonoscopy or rectosigmoidoscopy. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of alpha-synuclein aggregates in colonic biopsies using 2D electrophoresis | Colonic biopsies are obtained during the course of colonoscopy or rectosigmoidoscopy. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biopsies, enteric nervous system, biomarker