Analysis of the Enteric Nervous System Using Colonic Biopsies - Full Text View

Purpose

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	Intervention
Parkinson's Disease Multiple System Atrophy Progressive Supranuclear Palsy	Procedure: colonoscopy or rectosigmoidoscopy


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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?

Resource links provided by NLM:

Genetics Home Reference related topics: multiple system atrophy Parkinson disease popliteal pterygium syndrome progressive supranuclear palsy

MedlinePlus related topics: Paralysis Progressive Supranuclear Palsy

Genetic and Rare Diseases Information Center resources: Motor Neuro-ophthalmic Disorders Multiple System Atrophy Multiple System Atrophy (MSA) With Orthostatic Hypotension Ocular Motility Disorders Popliteal Pterygium Syndrome Progressive Supranuclear Palsy Proximal Spinal Muscular Atrophy

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:

Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Colonic biopsies are obtained during the course of colonoscopy or rectosigmoidoscopy.


Enrollment:	34
Study Start Date:	November 2010
Study Completion Date:	November 2012
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Colonic biopsies Colonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy	Procedure: colonoscopy or rectosigmoidoscopy Usual procedure

Eligibility


Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided


Responsible Party:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT01353183 History of Changes
Other Study ID Numbers:	10/4-U, ID RCB 2010-A00632-37
Study First Received:	January 31, 2011
Last Updated:	September 18, 2013
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:


biopsies, enteric nervous system, biomarker

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on March 03, 2015

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