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Skin Biopsies in Chemotherapy-Induced Neuropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00956033
First Posted: August 11, 2009
Last Update Posted: December 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Joost LM Jongen, Erasmus Medical Center
  Purpose
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.

Condition
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 Joost LM Jongen, Erasmus Medical Center:

Primary Outcome Measures:
  • intraepidermal nerve fiber density/pain intensity [ Time Frame: one timepoint, i.e. date of skin biopsy ]
    correlation between intraepidermal nerve fiber density and pain intensity


Biospecimen Retention:   Samples Without DNA
skin biopsy

Enrollment: 26
Study Start Date: November 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with multiple myeloma

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with multiple myeloma receiving bortezomib in a large university hospital
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956033


Locations
Netherlands
Erasmus MC, Centrumlocatie en Daniel den Hoed
Rotterdam, Zuid-Holland, Netherlands, 3000CA
Sponsors and Collaborators
Erasmus Medical Center
Investigators
Principal Investigator: Joost L Jongen Erasmus MC
  More Information

Additional Information:
Responsible Party: Joost LM Jongen, J.L.M. Jongen, MD, PhD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT00956033     History of Changes
Other Study ID Numbers: MEC2008-305
First Submitted: August 10, 2009
First Posted: August 11, 2009
Last Update Posted: December 24, 2014
Last Verified: December 2014

Keywords provided by Joost LM Jongen, Erasmus Medical Center:
Cancer
Peripheral Neuropathy
Bortezomib

Additional relevant MeSH terms:
Multiple Myeloma
Peripheral Nervous System Diseases
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neuromuscular Diseases
Nervous System Diseases