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
Sponsor:
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00956033
First received: August 10, 2009
Last updated: June 21, 2011
Last verified: June 2011

August 10, 2009
June 21, 2011
November 2008
November 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00956033 on ClinicalTrials.gov Archive Site
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Skin Biopsies in Chemotherapy-Induced Neuropathy
Skin Biopsies in Chemotherapy-induced Neuropathy

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

skin biopsy

Non-Probability Sample

Patients with multiple myeloma receiving bortezomib in a large university hospital

  • Multiple Myeloma
  • Peripheral Neuropathy
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Patients with multiple myeloma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
November 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with multiple myeloma receiving bortezomib

Exclusion Criteria:

  • Patients not able to provide informed consent
  • Patients with coagulation disturbances or immunocompromised patients
Both
18 Years and older
No
Not Provided
Netherlands
 
NCT00956033
MEC2008-305
No
Joost L.M. Jongen, MD PhD, Erasmus MC
Erasmus Medical Center
Not Provided
Principal Investigator: Joost L Jongen Erasmus MC
Erasmus Medical Center
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP