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Completed

NCT Number: NCT01353183

Analysis of the Enteric Nervous System Using Colonic Biopsies

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.

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Key information

Conditions

Parkinson's Disease Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cranial Nerve Diseases Eye Diseases Movement Disorders Multiple System Atrophy Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Ocular Motility Disorders Ophthalmoplegia Paralysis Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Primary Dysautonomias Progressive Supranuclear Palsy Signs and Symptoms Supranuclear Palsy, Progressive Synucleinopathies Tauopathies

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes University Hospital

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

colonoscopy or rectosigmoidoscopy

Procedure

Usual procedure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: ColoBioParker

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 12, 2011
Registry last updated
Sep 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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