MelanomaNCT01085396
Use of Fiber-optic Probe for Non-invasive Diagnosis of Melanoma and Assessment of Impact of Ultraviolet (UV) Exposure on Skin
An observational study of Melanoma, run by University of Pittsburgh at 3 sites in United States.
Trial summary
This study is designed to collect information about melanoma using a research probe, a device placed only on the skin. This study will investigate whether using the probe to examine skin lesions could improve the accuracy of identification pre-cancerous melanoma lesions or to predict the risk melanoma in the skin of… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2010to Oct 2014
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. normal volunteers 2. patients without personal and family history of melanoma 3. patients with personal or family history of melanoma who are followed in the UPCI Melanoma Program with either atypical nevi or without atypical nevi.
Who may be able to join
- Male and female above 18 years of age;
- Subjects who are planned to undergo skin examinations with and without atypical nevi, with and without personal or family history of melanoma and potentially with pigmented lesions to be removed for medical care or cosmetic purposes.
Who cannot join
- Individuals whose pathology cannot be obtained or retrieved.
- Inability to provide informed consent.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UPMC Presbyterian Dept. of Dermatology
Pittsburgh, Pennsylvania, 15213
UPCI - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
UPMC Shadyside Place - Dermatology Unit
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Optical Spectroscopy for Non-invasive Diagnosis of Melanoma and Assessment of Impact of UV Exposure on Skin
This study is designed to collect information about melanoma using a research probe, a device placed only on the skin. This study will investigate whether using the probe to examine skin lesions could improve the accuracy of identification pre-cancerous melanoma lesions or to predict the risk melanoma in the skin of subjects. Ultimately, we would see this technique used routinely as a non-invasive device during subjects' skin examination to aid dermatologists to identify pre-cancerous (melanoma) lesions without taking tissue samples of the skin. Alternatively, this technique would, in the future, also be used to screen patients at risk for melanoma.
- Conditions
- Melanoma
- Keywords
- Fiber Optic, Melanoma, UV Exposure
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the ability of the fiber-optic probe to identify lesions of melanoma and severe/high-grade dysplasia
To correct for skin color effect and heterogeneity, the readings of the pigmented lesion will be normalized by the readings taken from the corresponding normal skin around the lesion.
Measured: 3 years
Secondary outcomes (3)
To test whether the fiber-optic probe can discriminate the severe/high-grade dysplasia from the mild and moderate dysplastic nevi;
Measured: 3 years
To test whether the fiber-optic probe readings are different among tissues with different degree of sun exposure
Measured: 3 years
To test whether the fiber-optic probe readings are different between the most and the least suspicious lesions
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: Ran out of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Liu, PhD, University of Pittsburgh
- Investigators
- Yang Liu, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085396
- Sponsor's protocol ID
- UPCI 09-077
- Status last verified
- May 2014
- First submitted
- 10 Mar 2010
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Spectroscopy for Non-invasive Diagnosis of Melanoma and Assessment of Impact of UV Exposure on Skin
- ClinicalTrials.gov ID
- NCT01085396
- Acronym / sponsor ID
- UPCI 09-077
- Conditions
- Melanoma
- Keywords
- Fiber Optic, Melanoma, UV Exposure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Ran out of funding
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 11 Mar 2010 (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.
This study is designed to collect information about melanoma using a research probe, a device placed only on the skin. This study will investigate whether using the probe to examine skin lesions could improve the accuracy of identification pre-cancerous melanoma lesions or to predict the risk melanoma in the skin of subjects. Ultimately, we would see this technique used routinely as a non-invasive device during subjects' skin examination to aid dermatologists to identify pre-cancerous (melanoma) lesions without taking tissue samples of the skin. Alternatively, this technique would, in the future, also be used to screen patients at risk for melanoma.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. normal volunteers 2. patients without personal and family history of melanoma 3. patients with personal or family history of melanoma who are followed in the UPCI Melanoma Program with either atypical nevi or without atypical nevi.
Key inclusion criteria (2 listed)
- Male and female above 18 years of age;
- Subjects who are planned to undergo skin examinations with and without atypical nevi, with and without personal or family history of melanoma and potentially with pigmented lesions to be removed for medical care or cosmetic purposes.
Key exclusion criteria (2 listed)
- Individuals whose pathology cannot be obtained or retrieved.
- Inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Investigate the ability of the fiber-optic probe to identify lesions of melanoma and severe/high-grade dysplasia
Time frame: 3 years
To correct for skin color effect and heterogeneity, the readings of the pigmented lesion will be normalized by the readings taken from the corresponding normal skin around the lesion.
3 secondary outcomes
To test whether the fiber-optic probe can discriminate the severe/high-grade dysplasia from the mild and moderate dysplastic nevi;
Time frame: 3 years
To test whether the fiber-optic probe readings are different among tissues with different degree of sun exposure
Time frame: 3 years
To test whether the fiber-optic probe readings are different between the most and the least suspicious lesions
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Ran out of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
Yang Liu, PhD principal investigator
University of Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by University of Pittsburgh at 3 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: stopped early, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 was stopped early (reason given: Ran out of funding). Results are not available in the source record.
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?
Investigate the ability of the fiber-optic probe to identify lesions of melanoma and severe/high-grade dysplasia (time frame: 3 years). 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 27 May 2015.