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
  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 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)
Groups/Cohorts
Patients with multiple myeloma

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956033

Locations
Netherlands
Erasmus MC, Centrumlocatie en Daniel den Hoed Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3000CA
Contact: Joost L Jongen, MD PhD    +31107035754    j.jongen@erasmusmc.nl   
Contact: Pieter A van Doorn, MD PhD    +31107033780    p.a.vandoorn@erasmusmc.nl   
Principal Investigator: Joost L Jongen, MD PhD         
Sponsors and Collaborators
Erasmus Medical Center
Investigators
Principal Investigator: Joost L Jongen Erasmus MC
  More Information

Additional Information:
No publications provided

Responsible Party: Joost L.M. Jongen, MD PhD, Erasmus MC
ClinicalTrials.gov 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:
Cancer
Peripheral Neuropathy
Bortezomib

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Peripheral Nervous System Diseases
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

ClinicalTrials.gov processed this record on August 27, 2014