ColoBioParker: Analysis of the Enteric Nervous System Using Colonic Biopsies

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01353183
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 1.4

Study Details

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	N/A

Study Design

• Study Type: Interventional
• 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: Nov 1, 2010
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

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

1. 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

1. Presence of alpha-synuclein aggregates in colonic biopsies using 2D electrophoresis [3 months]

   Colonic biopsies are obtained during the course of colonoscopy or rectosigmoidoscopy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Nantes University Hospital	Nantes		France	44093

Sponsors and Collaborators

• Nantes University Hospital

Investigators

• Principal Investigator: DERKINDEREN Pascal, Professor, Nantes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT01353183
• Other Study ID Numbers: 10/4-U; ID RCB 2010-A00632-37
• First Posted: May 12, 2011
• Last Update Posted: Sep 19, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by Nantes University Hospital: biopsies, enteric nervous system, biomarker
• Additional relevant MeSH terms: Parkinson Disease; Multiple System Atrophy; Shy-Drager Syndrome; Supranuclear Palsy, Progressive

Study Results

No Results Posted as of Sep 19, 2013