ClinicalTrials.gg
CompletedNCT00540566Updated Oct 20, 2022

Optical Biopsy of Human Skin in Conjunction With Laser Treatment

An observational study in Malignant Melanoma, Merkel Cell Carcinoma and Basal Cell Carcinoma, sponsored by University of California, Irvine. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-20.

Sponsored by University of California, Irvine · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
113
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study is to compare the ability of optical biopsy. Research can use light enters the skin, collected, analyzed by the computer, and a picture created for the pathologist to conventional histologic examination compare with the pathologist looking at the piece of tissue through a microscope makes the diagnosis.

Read the detailed description

The Optical measurements provide quantitative optical property values that reflect changes in tissue perfusion, oxygen consumption, and cell/matrix development. Each measurement requires less than 5 minutes to execute. The measurements will be taken before and after skin treatment.This non-invasive, non-contact technique has great potential as a means to diagnose different skin problems without the need to obtain a piece of tissue from the skin.

02

Conditions studied

  • Malignant Melanoma
  • Merkel Cell Carcinoma
  • Basal Cell Carcinoma
  • Squamous Cell Carcinoma
  • Atypical Nevi
  • Congenital Nevi
  • Seborrheic Keratosis
  • Paget's Disease
  • Dermatofibroma
  • Kaposi's Sarcoma
  • Port Wine Stain
  • Hemangioma
  • Tattoos
  • Scleroderma
  • Burns
03

In context

Melanoma

3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.

This study's enrollment of 113 is below the median of 187 across 488 observational studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

University of California, Irvine is the lead sponsor of 476 studies on the registry; 98 are open to participants now.

Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

primary care clinic, community sample

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female age > 18 years

Exclusion criteria

Exclusion Criteria:

  • current participation in any other drug evaluation
  • inability to understand and carry out instructions
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
113 participants (actual)

Groups and cohorts

  • Optical Biopsy

    Optical Biopsy imaging

    Device: Optical Biopsy imaging

Interventions

  • DeviceOptical Biopsy imaging

    Optical Biopsy imaging

06

What researchers measure

Primary outcomes

  1. normal skin

    Time frame: 12 weeks

07

Study locations

1 site
  • Beckman Laser Institute, Unversity of California Irvine
    Irvine, California 92612, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 1999, a primary completion of Jun 2008 and a completion of Jul 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2007
First posted
Oct 8, 2007
Start
Jun 1999
Primary completionActual
Jun 2008
CompletionActual
Jul 2008
Last update
Oct 20, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00540566
Collaborators
Beckman Laser Institute University of California Irvine
Responsible party
Beckman Laser Institute and Medical Center (J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering, University of California, Irvine) — Principal investigator
First posted
Oct 8, 2007
Start date
Jun 1999
Primary completion
Jun 2008
Completion
Jul 2008
Last update
Oct 20, 2022

Study contacts

John S Nelson, M.D,Ph.D
principal investigator · Beckman Laser Institue, University of California Irvine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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