NCT01353183

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 12, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

September 19, 2013

Status Verified

September 1, 2013

Enrollment Period

2 years

First QC Date

January 31, 2011

Last Update Submit

September 18, 2013

Conditions

Parkinson's DiseaseMultiple System AtrophyProgressive Supranuclear Palsy

Keywords

biopsies, enteric nervous system, biomarker

Outcome Measures

Primary Outcomes (1)

  • Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry

    Colonic biopsies are obtained during the course of colonoscopy or rectosigmoidoscopy.

    3 months

Secondary Outcomes (1)

  • Presence of alpha-synuclein aggregates in colonic biopsies using 2D electrophoresis

    3 months

Study Arms (1)

Colonic biopsies

EXPERIMENTAL

Colonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy

Procedure: colonoscopy or rectosigmoidoscopy

Interventions

colonoscopy or rectosigmoidoscopyPROCEDURE

Usual procedure

Colonic biopsies

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Conditions

Parkinson DiseaseMultiple System AtrophySupranuclear Palsy, Progressive

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesPrimary DysautonomiasAutonomic Nervous System DiseasesOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesTauopathiesParalysisNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • DERKINDEREN Pascal, Professor

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2011

First Posted

May 12, 2011

Study Start

November 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

September 19, 2013

Record last verified: 2013-09

Locations

FR(1)