Skin CancerNCT02704039
Multimodal Spectroscopy (MMS) for in Vivo Noninvasive Assessment of Skin
An observational study of Skin Cancer, run by University of Texas at Austin at 1 site in United States.
Trial summary
The goal of this research program is to develop a simple, noninvasive diagnostic device for assessing skin pathology without the need for a biopsy. The device being studied is a single system capable of collecting three spectroscopy measurements (Raman, diffuse reflectance and laser induced fluorescence spectroscopy)… 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
- How many people
- 239 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Dec 2018
- 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: Health adult volunteers being evaluated by dermatologist for lesion of interest (see inclusion criteria).
Who may be able to join
- Patients undergoing examination of skin
- Male or Female 18 years and older
- Patients with lesion(s) including one of the following: BCC, SCC, pre-cancerous, pigmented lesion, benign lesions, OR suspected diagnosis of psoriasis, eczema, dermatitis, lichen planus and/or lupus.
- Signed consent form
Who cannot join
- Patients with skin lesions in difficult to measure locations
- Patients that do not sign the consent forms
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this research program is to develop a simple, noninvasive diagnostic device for assessing skin pathology without the need for a biopsy. The device being studied is a single system capable of collecting three spectroscopy measurements (Raman, diffuse reflectance and laser induced fluorescence spectroscopy) from skin lesion sites. In order to accomplish this objective, the investigators propose to: 1) develop biophysical model for Raman spectroscopy of skin cancers, 2) conduct a clinical pilot study to collect MMS data from a minimum of 250 patients to determine the diagnostic accuracy (sensitivity and specificity) of MMS for diagnosing skin malignancy.
Read the detailed description
To develop a biophysical model the investigators will recruit patients based on their known histopathology diagnoses, from each of 6 skin-cancer categories: basal cell carcinoma, squamous cell carcinoma, melanoma, atypical nevus, actinic keratosis, and benign skin. Patients with non-cancer diagnosis such as psoriasis, eczema / dermatitis, lichen planus or lupus will also be recruited. Recruitment will include 5 patients from each of these categories, giving a total of 20 patients. Measurements for the biophysical models are conducted on skin tissues that have been excised from the patients. Furthermore, these skin tissues are excised tissues that under standard screening procedure will be biopsied by the dermatologist. Therefore, patients are not undergoing extra \& unnecessary biopsies, and will not be exposed to any risk involved with the microspectroscopy measurements.
To determine the diagnostic accuracy of MMS, MMS data will be collected from six clinical groups, each with a preoperative diagnosis: 1) malignant melanoma (MM), 2) basal cell carcinoma (BCC), 3) squamous cell carcinoma (SCC), 4) pre-cancerous lesions (AK), 5) benign or atypical nevi, or 6) other lesions or conditions (rare skin cancers such as merkel cell carcinoma, and inflammatory conditions such as psoriasis). The aim is to collect MMS data from a minimum of 240 patients (40 patients for each of the 6 groups), which will be split to training and validation datasets. Since several biopsies are required to diagnose a single skin cancer, it is anticipated that the actual number of pre-cancerous, benign and inflammatory lesions sampled will be much higher than our target total of 240, to be around 300. We will also collect data from non-skin cancer skin conditions: 1) psoriasis, 2) eczema / dermatitis, 3) lichen planus and 4) lupus. For the non-skin-cancer part of the study, we will enroll 20 patients from each of the categories, with a total target of 80 patients.
- Conditions
- Skin Cancer
- Medical subject headings
- Skin Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1: Develop biophysical model for Raman spectroscopy
use of a new technique of biophysical modeling to analyze the Raman spectra. At the core of the technique is the measurement of a set of "basis spectra" which are fit to the data using ordinary least-squares.
Measured: 6 months
Aim 2: Perform clinical assessment of MMS for skin malignancy
develop a biophysically-orientated model of human skin using Raman spectroscopy, with the goal of obtaining tissue microenvironment structural and chemical information.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2017
- Study completionDec 2018
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 Texas at AustinThe 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Seton Healthcare Family, Cancer Prevention Research Institute of Texas
- Responsible party
- Sponsor
- Investigators
- James Tunnell, PhD, Principal investigator, University of Texas at AustinJason Reichenberg, MD, Principal investigator, Seton & The University of Texas at Austin Dell Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704039
- Sponsor's protocol ID
- 2013-07-0008
- Status last verified
- Mar 2019
- First submitted
- 3 Mar 2016
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Spectroscopy (MMS) for in Vivo Noninvasive Assessment of Skin
- ClinicalTrials.gov ID
- NCT02704039
- Acronym / sponsor ID
- 2013-07-0008
- Conditions
- Skin Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Seton Healthcare Family, Cancer Prevention Research Institute of Texas
- Study start
- Jan 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 9 Mar 2016 (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 goal of this research program is to develop a simple, noninvasive diagnostic device for assessing skin pathology without the need for a biopsy. The device being studied is a single system capable of collecting three spectroscopy measurements (Raman, diffuse reflectance and laser induced fluorescence spectroscopy) from skin lesion sites. In order to accomplish this objective, the investigators propose to: 1) develop biophysical model for Raman spectroscopy of skin cancers, 2) conduct a clinical pilot study to collect MMS data from a minimum of 250 patients to determine the diagnostic accuracy (sensitivity and specificity) of MMS for diagnosing skin malignancy.
Detailed description
To develop a biophysical model the investigators will recruit patients based on their known histopathology diagnoses, from each of 6 skin-cancer categories: basal cell carcinoma, squamous cell carcinoma, melanoma, atypical nevus, actinic keratosis, and benign skin. Patients with non-cancer diagnosis such as psoriasis, eczema / dermatitis, lichen planus or lupus will also be recruited. Recruitment will include 5 patients from each of these categories, giving a total of 20 patients. Measurements for the biophysical models are conducted on skin tissues that have been excised from the patients. Furthermore, these skin tissues are excised tissues that under standard screening procedure will be biopsied by the dermatologist. Therefore, patients are not undergoing extra \& unnecessary biopsies, and will not be exposed to any risk involved with the microspectroscopy measurements.
To determine the diagnostic accuracy of MMS, MMS data will be collected from six clinical groups, each with a preoperative diagnosis: 1) malignant melanoma (MM), 2) basal cell carcinoma (BCC), 3) squamous cell carcinoma (SCC), 4) pre-cancerous lesions (AK), 5) benign or atypical nevi, or 6) other lesions or conditions (rare skin cancers such as merkel cell carcinoma, and inflammatory conditions such as psoriasis). The aim is to collect MMS data from a minimum of 240 patients (40 patients for each of the 6 groups), which will be split to training and validation datasets. Since several biopsies are required to diagnose a single skin cancer, it is anticipated that the actual number of pre-cancerous, benign and inflammatory lesions sampled will be much higher than our target total of 240, to be around 300. We will also collect data from non-skin cancer skin conditions: 1) psoriasis, 2) eczema / dermatitis, 3) lichen planus and 4) lupus. For the non-skin-cancer part of the study, we will enroll 20 patients from each of the categories, with a total target of 80 patients.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health adult volunteers being evaluated by dermatologist for lesion of interest (see inclusion criteria).
Key inclusion criteria (4 listed)
- Patients undergoing examination of skin
- Male or Female 18 years and older
- Patients with lesion(s) including one of the following: BCC, SCC, pre-cancerous, pigmented lesion, benign lesions, OR suspected diagnosis of psoriasis, eczema, dermatitis, lichen planus and/or lupus.
- Signed consent form
Key exclusion criteria (2 listed)
- Patients with skin lesions in difficult to measure locations
- Patients that do not sign the consent forms
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
Aim 1: Develop biophysical model for Raman spectroscopy
Time frame: 6 months
use of a new technique of biophysical modeling to analyze the Raman spectra. At the core of the technique is the measurement of a set of "basis spectra" which are fit to the data using ordinary least-squares.
Aim 2: Perform clinical assessment of MMS for skin malignancy
Time frame: 1 year
develop a biophysically-orientated model of human skin using Raman spectroscopy, with the goal of obtaining tissue microenvironment structural and chemical information.
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 13 Mar 2019.
- Individual participant dataSharing planned: No
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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.
James Tunnell, PhD principal investigator
University of Texas at Austin
Jason Reichenberg, MD principal investigator
Seton & The University of Texas at Austin Dell Medical School
1 site 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 Texas at Austin at 1 site 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 4 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 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Aim 1: Develop biophysical model for Raman spectroscopy (time frame: 6 months). The study lists 2 primary outcomes in all. 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 13 Mar 2019.