Analysis of the Enteric Nervous System Using Colonic Biop... | NCT01353183

Studies
Analysis of the Enteric Nervous System Using Colonic Biopsies

NCT01353183

Sponsor

Nantes University Hospital

Status

Completed

Last Update Posted

Sep 19, 2013Estimated

Enrollment

34Actual

Phase

Not Applicable

Conditions

Parkinson's Disease
Multiple System Atrophy
Progressive Supranuclear Palsy

Interventions

colonoscopy or rectosigmoidoscopy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ID RCB 2010-A00632-37	Registry Identifier	2010-A00632-37

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Jan 31, 2011

First Submission Date that Met QC Criteria

May 11, 2011

First Posted Date

May 12, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2013

Last Update Posted Date

Sep 19, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Colonic biopsies	Experimental	Colonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy	Procedure: colonoscopy or rectosigmoidoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
colonoscopy or rectosigmoidoscopy	Procedure	Usual procedure	Colonic biopsies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Presence of alpha-synuclein aggregates in colonic biopsies using 2D electrophoresis	Colonic biopsies are obtained during the course of colonoscopy or rectosigmoidoscopy.	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
DERKINDEREN Pascal, Professor	Nantes University Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Nantes University Hospital		Nantes		44093	France

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D019578	Multiple System Atrophy
D013494	Supranuclear Palsy, Progressive

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003113	Colonoscopy

Ancestor Terms

ID	Term
D016099	Endoscopy, Gastrointestinal
D016145	Endoscopy, Digestive System
D003938	Diagnostic Techniques, Digestive System
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided