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

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ClinicalTrials.gov Identifier: NCT01353183
Recruitment Status : Completed
First Posted : May 12, 2011
Last Update Posted : September 19, 2013
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date  ICMJE January 31, 2011
First Posted Date  ICMJE May 12, 2011
Last Update Posted Date September 19, 2013
Study Start Date  ICMJE November 2010
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01353183 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2011)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analysis of the Enteric Nervous System Using Colonic Biopsies
Official Title  ICMJE Analysis of the Enteric Nervous System Using Colonic Biopsies: a Useful Biomarker for the Differential Diagnosis of Parkinsonian Syndromes?
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Parkinson's Disease
  • Multiple System Atrophy
  • Progressive Supranuclear Palsy
Intervention  ICMJE Procedure: colonoscopy or rectosigmoidoscopy
Usual procedure
Study Arms  ICMJE Experimental: Colonic biopsies
Colonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy
Intervention: Procedure: colonoscopy or rectosigmoidoscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2013)
34
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2011)
24
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01353183
Other Study ID Numbers  ICMJE 10/4-U
ID RCB 2010-A00632-37 ( Registry Identifier: 2010-A00632-37 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nantes University Hospital
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: DERKINDEREN Pascal, Professor Nantes University Hospital
PRS Account Nantes University Hospital
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP