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Skin Biopsies in Chemotherapy-Induced Neuropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joost LM Jongen, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00956033
First received: August 10, 2009
Last updated: December 23, 2014
Last verified: December 2014

August 10, 2009
December 23, 2014
November 2008
February 2012   (final data collection date for primary outcome measure)
intraepidermal nerve fiber density/pain intensity [ Time Frame: one timepoint, i.e. date of skin biopsy ] [ Designated as safety issue: No ]
correlation between intraepidermal nerve fiber density and pain intensity
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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.
 
Completed
26
February 2012
February 2012   (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
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00956033
MEC2008-305
No
Joost LM Jongen, Erasmus Medical Center
Erasmus Medical Center
Not Provided
Principal Investigator: Joost L Jongen Erasmus MC
Erasmus Medical Center
December 2014

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