NCT00633516

Brief Summary

The incidence of malignant melanoma has increased dramatically in recent decades. In 1930, the lifetime risk of an individual in the United States developing melanoma was 1 in 1,500. This has been exponentially increasing over the years with the risk estimated to be 1 in 75 in 2000 . According to the American Cancer Society, approximately 59,580 new cases of melanoma will be diagnosed in the United States in 2005 and about 7,770 people are expected to die of the disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2008

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

5.3 years

First QC Date

March 4, 2008

Last Update Submit

October 28, 2022

Conditions

Keywords

molesmelanoma

Outcome Measures

Primary Outcomes (1)

  • Measure atypical moles and melanoma

    Optical Spectroscopy imaging of atypical moles and melanoma to correlate results from the results of the biopsy tissue histology

    4 weeks

Study Arms (1)

Medical tool

Optical Spectroscopy imaging are Modified Two Layer Diffuse Optical Spectroscopy and multi-spectral imaging and Spatially Modulated Quantitative Spectroscopy

Device: Optical Spectroscopy

Interventions

Optical Spectroscopy imaging are Modified Two Layer Diffuse Optical Spectroscopy and multi-spectral imaging and Spatially Modulated Quantitative Spectroscopy

Also known as: Optical Spectroscopy imaging
Medical tool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic

You may qualify if:

  • years or older.
  • Have atypical mole/s and melanoma

You may not qualify if:

  • Age less than 18 years old.
  • have NO atypical mole/s and melanoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beckman Laser Medical clinic, UCI

Irvine, California, 92612, United States

Location

UCIMC

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Skin NeoplasmsNevusMelanoma

Interventions

Spectrum Analysis, Raman

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesNevi and MelanomasNeoplasms by Histologic TypeNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Scattering, RadiationChemistry Techniques, AnalyticalInvestigative TechniquesSpectrum Analysis

Study Officials

  • David JB Hsiang, MD

    Beckman Laser Institute University of California Irvine

    PRINCIPAL INVESTIGATOR
  • Bruce Tromberg, PhD

    Beckman Laser Institute University of California Irvine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
David Hsiang, M.D., Division of Surgical Oncology

Study Record Dates

First Submitted

March 4, 2008

First Posted

March 12, 2008

Study Start

July 1, 2008

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations