Analysis of the Enteric Nervous System Using Colonic Biopsies

Not Applicable

Completed

• Conditions: Parkinson's Disease; Multiple System Atrophy; Progressive Supranuclear Palsy

• Registration Number: NCT01353183
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-01-31
• Study First Submitted QC: 2011-05-11
• Study First Posted: 2011-05-12
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-18
• Last Update Posted: 2013-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry	3 months	Colonic biopsies are obtained during the course of colonoscopy or rectosigmoidoscopy.

Secondary Outcome Measures

Name	Time	Method
Presence of alpha-synuclein aggregates in colonic biopsies using 2D electrophoresis	3 months	Colonic biopsies are obtained during the course of colonoscopy or rectosigmoidoscopy.

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France