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Skin Biopsies in Chemotherapy-Induced Neuropathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Erasmus Medical Center.
Recruitment status was  Recruiting
Information provided by:
Erasmus Medical Center Identifier:
First received: August 10, 2009
Last updated: June 21, 2011
Last verified: June 2011

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.

Multiple Myeloma
Peripheral Neuropathy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Skin Biopsies in Chemotherapy-induced Neuropathy

Resource links provided by NLM:

Further study details as provided by Erasmus Medical Center:

Biospecimen Retention:   Samples Without DNA

skin biopsy

Estimated Enrollment: 100
Study Start Date: November 2008
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Patients with multiple myeloma


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with multiple myeloma receiving bortezomib in a large university hospital


Inclusion Criteria:

  • Patients with multiple myeloma receiving bortezomib

Exclusion Criteria:

  • Patients not able to provide informed consent
  • Patients with coagulation disturbances or immunocompromised patients
  Contacts and Locations
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Please refer to this study by its identifier: NCT00956033

Erasmus MC, Centrumlocatie en Daniel den Hoed Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3000CA
Contact: Joost L Jongen, MD PhD    +31107035754   
Contact: Pieter A van Doorn, MD PhD    +31107033780   
Principal Investigator: Joost L Jongen, MD PhD         
Sponsors and Collaborators
Erasmus Medical Center
Principal Investigator: Joost L Jongen Erasmus MC
  More Information

Additional Information:
No publications provided

Responsible Party: Joost L.M. Jongen, MD PhD, Erasmus MC Identifier: NCT00956033     History of Changes
Other Study ID Numbers: MEC2008-305
Study First Received: August 10, 2009
Last Updated: June 21, 2011
Health Authority: Netherlands: Dutch Health Care Inspectorate

Keywords provided by Erasmus Medical Center:
Peripheral Neuropathy

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Peripheral Nervous System Diseases
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Nervous System Diseases
Neuromuscular Diseases
Vascular Diseases processed this record on November 20, 2014