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

September 18, 2013 updated by: Nantes University Hospital

Analysis of the Enteric Nervous System Using Colonic Biopsies: a Useful Biomarker for the Differential Diagnosis of Parkinsonian Syndromes?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44093
        • Nantes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

January 31, 2011

First Submitted That Met QC Criteria

May 11, 2011

First Posted (Estimate)

May 12, 2011

Study Record Updates

Last Update Posted (Estimate)

September 19, 2013

Last Update Submitted That Met QC Criteria

September 18, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/4-U
  • ID RCB 2010-A00632-37 (Registry Identifier: 2010-A00632-37)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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