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Analysis of the Enteric Nervous System Using Colonic Biopsies (ColoBioParker)
This study has been completed.
Sponsor:
Nantes University Hospital
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01353183
First received: January 31, 2011
Last updated: September 18, 2013
Last verified: September 2013
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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 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:
Parkinson disease
multiple system atrophy
progressive supranuclear palsy
MedlinePlus related topics:
Biopsy
Genetic and Rare Diseases Information Center resources:
Progressive Supranuclear Palsy
Multiple System Atrophy
Ocular Motility Disorders
Motor Neuro-ophthalmic Disorders
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 ]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.
| 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 (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
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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
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
| 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 ) |
| Study First Received: | January 31, 2011 |
| Last Updated: | September 18, 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 |
ClinicalTrials.gov processed this record on July 26, 2017