NCT00391300

Brief Summary

RATIONALE: New diagnostic procedures, such as bioelectric field imaging, may help find and diagnose melanoma and other skin cancers. It may also be a less invasive way to check for skin cancer. PURPOSE: This phase I trial is studying bioelectric field imaging in diagnosing melanoma and other skin cancers in patients with skin lesions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2006

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 23, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

December 18, 2013

Status Verified

October 1, 2008

Enrollment Period

6 months

First QC Date

October 2, 2006

Last Update Submit

December 17, 2013

Conditions

Melanoma (Skin)Non-melanomatous Skin Cancer

Keywords

melanomabasal cell carcinoma of the skinsquamous cell carcinoma of the skin

Outcome Measures

Primary Outcomes (2)

  • Use of Bioelectric Field Imager (BFI) in measuring the electric field in skin of various body surfaces

  • Use of BFI in detecting significant electric field differences between malignant and benign skin lesions

Interventions

bioelectric field imagingPROCEDURE
biopsyPROCEDURE
histopathologic examinationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Suspected malignant skin lesion * Seeking treatment for skin lesion at the VA Medical Center PATIENT CHARACTERISTICS: * Not pregnant * No acute illness, including upper respiratory tract infection or flu that could result in fever * No trauma to the skin lesion area * No prisoners PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

VA Hospital

Hampton, Virginia, 23667, United States

Location

MeSH Terms

Conditions

MelanomaCarcinoma, Basal Cell

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Antoinette F. Hood, MD

    Eastern Virginia Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 2, 2006

First Posted

October 23, 2006

Study Start

October 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

December 18, 2013

Record last verified: 2008-10

Locations

US(1)