Skin Biopsies in Chemotherapy-Induced Neuropathy | NCT00956033

Studies
Skin Biopsies in Chemotherapy-Induced Neuropathy

NCT00956033

Sponsor

Erasmus Medical Center

Status

Completed

Last Update Posted

Dec 24, 2014Estimated

Enrollment

26Actual

Phase

Not provided

Conditions

Multiple Myeloma
Peripheral Neuropathy

Interventions

Not provided

Countries

Netherlands

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

Status Module

Record Verification Date

Dec 2014

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 2008

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Aug 10, 2009

First Submission Date that Met QC Criteria

Aug 10, 2009

First Posted Date

Aug 11, 2009Estimated

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

Dec 23, 2014

Last Update Posted Date

Dec 24, 2014Estimated

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

Neuropathy is a common side effect of chemotherapeutics used for the treatment of multiple myeloma, including vincristine, thalidomide and bortezomib. The neuropathy induced by these drugs is often preferentially small fiber. Small fiber neuropathies are difficult to diagnose and quantify using conventional electromyography. Determining intra-epidermal nerve fiber density (IENFD) in skin biopsies from diabetes and AIDS patients has been shown to be a more sensitive and more specific ancillary investigation to establish the diagnosis of small fiber neuropathy. In this study the investigators aim to establish the sensitivity of IENFD measurements in skin biopsies from patients with multiple myeloma treated with bortezomib.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

26Actual

Label	Type	Description	Intervention Names
Patients with multiple myeloma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intraepidermal nerve fiber density/pain intensity	correlation between intraepidermal nerve fiber density and pain intensity	one timepoint, i.e. date of skin biopsy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with multiple myeloma receiving bortezomib

Exclusion Criteria:

Patients not able to provide informed consent
Patients with coagulation disturbances or immunocompromised patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with multiple myeloma receiving bortezomib in a large university hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joost L Jongen	Erasmus Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erasmus MC, Centrumlocatie en Daniel den Hoed		Rotterdam	South Holland	3000CA	Netherlands

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma
D010523	Peripheral Nervous System Diseases
D009369	Neoplasms

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D020141	Hemostatic Disorders
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

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