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

Primary Purpose

Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
colonoscopy or rectosigmoidoscopy
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson's Disease focused on measuring biopsies, enteric nervous system, biomarker

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nantes University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Colonic biopsies

Arm Description

Colonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy

Outcomes

Primary Outcome Measures

Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry
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
Colonic biopsies are obtained during the course of colonoscopy or rectosigmoidoscopy.

Full Information

First Posted
January 31, 2011
Last Updated
September 18, 2013
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01353183
Brief Title
Analysis of the Enteric Nervous System Using Colonic Biopsies
Acronym
ColoBioParker
Official Title
Analysis of the Enteric Nervous System Using Colonic Biopsies: a Useful Biomarker for the Differential Diagnosis of Parkinsonian Syndromes?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy
Keywords
biopsies, enteric nervous system, biomarker

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colonic biopsies
Arm Type
Experimental
Arm Description
Colonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy
Intervention Type
Procedure
Intervention Name(s)
colonoscopy or rectosigmoidoscopy
Intervention Description
Usual procedure
Primary Outcome Measure Information:
Title
Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry
Description
Colonic biopsies are obtained during the course of colonoscopy or rectosigmoidoscopy.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Presence of alpha-synuclein aggregates in colonic biopsies using 2D electrophoresis
Description
Colonic biopsies are obtained during the course of colonoscopy or rectosigmoidoscopy.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DERKINDEREN Pascal, Professor
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

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Analysis of the Enteric Nervous System Using Colonic Biopsies

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