A Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT01014819
First received: November 16, 2009
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

The Dermacorder measures the electric field in the skin. Malignant skin lesions disrupt the skin's normal electric field and this abnormal electric field can be detected by the Dermacorder. Therefore the investigators are testing the hypothesis that the Dermacorder can provide useful data to guide in the diagnosis of skin disease.


Condition
Basal Cell Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Phase I Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions

Resource links provided by NLM:


Further study details as provided by Children's Hospital & Research Center Oakland:

Estimated Enrollment: 30
Study Start Date: October 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Detailed Description:

The Dermacorder is a non-invasive medical device that scans a probe over the skin about 200 microns away from it and detects the electric field in the skin using capacitative coupling. Measurements of hundreds of malignant melanomas in mice indicated that these lesions generate an electric field that is easily detected. One previous clinical trial at the VA Medical Center in Hampton VA indicated an 80% reliability in predicting malignant lesions by their electric field. We have improved the Dermacorder over the past two years by enhancing its sensitivity and stability and must now determine if these improvements have improved its ability to detect malignant lesions. If the Dermacorder provides a reliable diagnosis of malignant lesions, its use could dramatically reduce the number of biopsies performed and this would significantly improve the quality of life for hundreds of thousands of Americans seeking the advice of dermatologists regarding suspicious lesions each year

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Males and females with multiple basal cell carcinomas

Criteria

Inclusion Criteria:

  • Study subjects must have had diagnosed at least one benign or malignant skin lesion;
  • Subject is from 18-75 years of age, inclusive;
  • Subject must sign and date all informed consent statements.

Exclusion Criteria:

  • Subject is exhibiting signs of a bacterial or viral infection, including fever;
  • Subject is unwilling to allow a biopsy of a malignant lesion for histological analysis.
  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: NCT01014819

Locations
United States, California
Childrens Hospital Oakland Research Institute
Oakland, California, United States, 94609
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Investigators
Principal Investigator: Ervin Epstein, M.D. Children's Hospital & Research Center Oakland
  More Information

No publications provided

Responsible Party: Ervin Epstein, MD Scientist, Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT01014819     History of Changes
Other Study ID Numbers: 2009-36
Study First Received: November 16, 2009
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital & Research Center Oakland:
Dermacorder
Electric field
basal cell carcinoma
Gorlin Syndrome

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on July 23, 2014