A Pilot Study to Evaluate Optical Spectroscopy of Pigmented Skin Lesions
A Pilot Study to Evaluate the Correlation Between Modified Two Layer Diffuse Optical Spectroscopy With the Clinical and Histological Examinations of Pigmented Skin Lesions Based on Physiological Parameters
1 other identifier
observational
37
1 country
2
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2008
Longer than P75 for all trials
2 active sites
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
First Submitted
Initial submission to the registry
March 4, 2008
CompletedFirst Posted
Study publicly available on registry
March 12, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 1, 2022
October 1, 2022
5.3 years
March 4, 2008
October 28, 2022
Conditions
Keywords
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
Interventions
Optical Spectroscopy imaging are Modified Two Layer Diffuse Optical Spectroscopy and multi-spectral imaging and Spatially Modulated Quantitative Spectroscopy
Eligibility Criteria
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
UCIMC
Orange, California, 92868, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David JB Hsiang, MD
Beckman Laser Institute University of California Irvine
- STUDY DIRECTOR
Bruce Tromberg, PhD
Beckman Laser Institute University of California Irvine
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