Skin CancerNCT00633516
A Pilot Study to Evaluate Optical Spectroscopy of Pigmented Skin Lesions
An observational study of Skin Cancer, run by University of California, Irvine at 2 sites in United States.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Optical Spectroscopy
- Type of treatment
- Medical device
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2008to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- 18 years or older.
- Have atypical mole/s and melanoma
Who cannot join
- Age less than 18 years old.
- have NO atypical mole/s and melanoma
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beckman Laser Medical clinic, UCI
Irvine, California, 92612
UCIMC
Orange, California, 92868
About this study
Official title: 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
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.
Read the detailed description
The researcher ucan use special imaging devices to obtain information about a typical mole and melanoma and use this information to determine the different between malignant and benign melanized lesions. The imaging devices are, Modified Two Layer Diffuse Optical Spectroscopy,multi-spectral imaging, and Spatially Modulated Quantitative Spectroscopy can use to measure atypical moles and melanoma and correlate the results of the biopsy tissue histology.
The imaging devices can quantify melanin, oxy and deoxy hemoglobin concentration, water, lipid and reduced scattering coefficients and can compare results to histopathologic. Atypical moles and melanoma have a different optical profile based on physiological parameters compared to benign nevus.
- Conditions
- Skin Cancer
- Being tested
- Optical Spectroscopy
- Keywords
- moles, melanoma
- Medical subject headings
- Skin Neoplasms, Nevus, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical SpectroscopyDevice
Also called Optical Spectroscopy imaging
Optical Spectroscopy imaging are Modified Two Layer Diffuse Optical Spectroscopy and multi-spectral imaging and Spatially Modulated Quantitative Spectroscopy
| Study group | Role | What they receive |
|---|---|---|
| Medical tool | Optical Spectroscopy imaging are Modified Two Layer Diffuse Optical Spectroscopy and multi-spectral imaging and Spatially Modulated Quantitative Spectroscopy Receives: Device: Optical Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure atypical moles and melanoma
Optical Spectroscopy imaging of atypical moles and melanoma to correlate results from the results of the biopsy tissue histology
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startJul 2008
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- David JB Hsiang, MD, Principal investigator, Beckman Laser Institute University of California IrvineBruce Tromberg, PhD, Study director, Beckman Laser Institute University of California Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633516
- Sponsor's protocol ID
- 20086099
- Status last verified
- Oct 2022
- First submitted
- 4 Mar 2008
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00633516
- Acronym / sponsor ID
- 20086099
- Conditions
- Skin Cancer
- Keywords
- moles, melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Jul 2008
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 12 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The researcher ucan use special imaging devices to obtain information about a typical mole and melanoma and use this information to determine the different between malignant and benign melanized lesions. The imaging devices are, Modified Two Layer Diffuse Optical Spectroscopy,multi-spectral imaging, and Spatially Modulated Quantitative Spectroscopy can use to measure atypical moles and melanoma and correlate the results of the biopsy tissue histology.
The imaging devices can quantify melanin, oxy and deoxy hemoglobin concentration, water, lipid and reduced scattering coefficients and can compare results to histopathologic. Atypical moles and melanoma have a different optical profile based on physiological parameters compared to benign nevus.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical tool | – | Device: Optical SpectroscopyOptical Spectroscopy imaging are Modified Two Layer Diffuse Optical Spectroscopy and multi-spectral imaging and Spatially Modulated Quantitative Spectroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (2 listed)
- 18 years or older.
- Have atypical mole/s and melanoma
Key exclusion criteria (2 listed)
- Age less than 18 years old.
- have NO atypical mole/s and melanoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical SpectroscopyAlso: Optical Spectroscopy imagingOptical Spectroscopy imaging are Modified Two Layer Diffuse Optical Spectroscopy and multi-spectral imaging and Spatially Modulated Quantitative Spectroscopy | Device | Medical tool |
Primary outcome
Measure atypical moles and melanoma
Time frame: 4 weeks
Optical Spectroscopy imaging of atypical moles and melanoma to correlate results from the results of the biopsy tissue histology
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David JB Hsiang, MD principal investigator
Beckman Laser Institute University of California Irvine
Bruce Tromberg, PhD study director
Beckman Laser Institute University of California Irvine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancer, run by University of California, Irvine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure atypical moles and melanoma (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.