Analysis of the Enteric Nervous System Using Colonic Biopsies

Parkinson's Disease Clinical Trial

— ColoBioParker  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01353183
• Other study ID #: 10/4-U
• Secondary ID: ID RCB 2010-A006
• Status: Completed
• Phase: N/A
• First received: January 31, 2011
• Last updated: September 18, 2013
• Start date: November 2010
• Est. completion date: November 2012

Study information

• Verified date: September 2013
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Multiple System Atrophy
• Parkinson Disease
• Parkinson's Disease
• Progressive Supranuclear Palsy
• Shy-Drager Syndrome
• Supranuclear Palsy, Progressive

Intervention

Procedure:
• colonoscopy or rectosigmoidoscopy
Usual procedure

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry	Colonic biopsies are obtained during the course of colonoscopy or rectosigmoidoscopy.	3 months	No
Secondary	Presence of alpha-synuclein aggregates in colonic biopsies using 2D electrophoresis	Colonic biopsies are obtained during the course of colonoscopy or rectosigmoidoscopy.	3 months	No