Analysis of the Enteric Nervous System Using Colonic Biopsies (ColoBioParker)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Parkinson's Disease; Multiple System Atrophy; Progressive Supranuclear Palsy	Procedure: colonoscopy or rectosigmoidoscopy	Not Applicable

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	34 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Analysis of the Enteric Nervous System Using Colonic Biopsies: a Useful Biomarker for the Differential Diagnosis of Parkinsonian Syndromes?
Study Start Date :	November 2010
Actual Primary Completion Date :	November 2012
Actual Study Completion Date :	November 2012

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Colonic biopsies; Colonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy	Procedure: colonoscopy or rectosigmoidoscopy; Usual procedure

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry [ Time Frame: 3 months ]
   Colonic biopsies are obtained during the course of colonoscopy or rectosigmoidoscopy.

Secondary Outcome Measures :

1. Presence of alpha-synuclein aggregates in colonic biopsies using 2D electrophoresis [ Time Frame: 3 months ]
   Colonic biopsies are obtained during the course of colonoscopy or rectosigmoidoscopy.

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	50 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

France
Nantes University Hospital
Nantes, France, 44093

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator:	DERKINDEREN Pascal, Professor	Nantes University Hospital

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT01353183 History of Changes
Other Study ID Numbers:	10/4-U; ID RCB 2010-A00632-37 ( Registry Identifier: 2010-A00632-37 )
First Posted:	May 12, 2011
Last Update Posted:	September 19, 2013
Last Verified:	September 2013

Keywords provided by Nantes University Hospital:

biopsies, enteric nervous system, biomarker

Additional relevant MeSH terms:

Parkinson Disease; Atrophy; Supranuclear Palsy, Progressive; Multiple System Atrophy; Shy-Drager Syndrome; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Pathological Conditions, Anatomical	Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Primary Dysautonomias; Autonomic Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases