Skin Biopsies in Chemotherapy-Induced Neuropathy

NCT00956033 | Completed

• 1 other identifier: MEC2008-305
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma; Peripheral Neuropathy

Keywords

Cancer; Peripheral Neuropathy; Bortezomib

Outcome Measures

Primary Outcomes (1)

• intraepidermal nerve fiber density/pain intensity

  correlation between intraepidermal nerve fiber density and pain intensity

  one timepoint, i.e. date of skin biopsy

Study Arms (1)

Patients with multiple myeloma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with multiple myeloma receiving bortezomib in a large university hospital

You may qualify if:

• Patients with multiple myeloma receiving bortezomib

You may not qualify if:

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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC, Centrumlocatie en Daniel den Hoed

Rotterdam, South Holland, 3000CA, Netherlands

Location

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITHOUT DNA

skin biopsy

MeSH Terms

Conditions

Multiple Myeloma; Peripheral Nervous System Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Joost L Jongen

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: J.L.M. Jongen, MD, PhD

Study Record Dates

• First Submitted: August 10, 2009
• First Posted: August 11, 2009
• Study Start: November 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: December 24, 2014

Record last verified: 2014-12

Locations

NL (1)