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

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ClinicalTrials.gov Identifier: NCT01353183

Recruitment Status : Completed

First Posted : May 12, 2011

Last Update Posted : September 19, 2013

Sponsor:

Information provided by (Responsible Party):

Nantes University Hospital

Study Description

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


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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Parkinson disease Multiple system atrophy Progressive supranuclear palsy

MedlinePlus related topics: Biopsy Colonoscopy

Genetic and Rare Diseases Information Center resources: Progressive Supranuclear Palsy Multiple System Atrophy Ocular Motility Disorders Motor Neuro-ophthalmic Disorders

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 :

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

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Ages Eligible for Study:	50 Years to 80 Years (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353183

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


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 Key Record Dates
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

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