Analysis of the Enteric Nervous System Using Colonic Biopsies

NCT ID: NCT01353183

Last Updated: 2013-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson's Disease Multiple System Atrophy Progressive Supranuclear Palsy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

biopsies, enteric nervous system, biomarker

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Colonic biopsies

Colonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy

Group Type EXPERIMENTAL

colonoscopy or rectosigmoidoscopy

Intervention Type PROCEDURE

Usual procedure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

colonoscopy or rectosigmoidoscopy

Usual procedure

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

DERKINDEREN Pascal, Professor

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nantes University Hospital

Nantes, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ID RCB 2010-A00632-37

Identifier Type: REGISTRY

Identifier Source: secondary_id

10/4-U

Identifier Type: -

Identifier Source: org_study_id