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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Nantes University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01353183
First received: January 31, 2011
Last updated: November 2, 2012
Last verified: August 2010
History of Changes
  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:

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.


Estimated Enrollment: 24
Study Start Date: November 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353183

Contacts
Contact: DERKINDEREN Pascal, Profesor (+33) 2.40.16.52.05 pascal.derkinderen@chu-nantes.fr

Locations
France
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Derkinderen Pascal, Professor     (=33) 2.40.16.52.05     pascal.derkinderen@chu-nantes.fr    
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: November 2, 2012
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:
Supranuclear Palsy, Progressive
Parkinson Disease
Multiple System Atrophy
Shy-Drager Syndrome
Atrophy
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Primary Dysautonomias
 Autonomic Nervous System Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Paralysis
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013