Suspicious Skin Lesion(s) Requiring a BiopsyNCT02522793
Optical Spectroscopy for Cutaneous Cancer
An observational study of Suspicious Skin Lesion(s) Requiring a Biopsy, run by Duke University at 1 site in United States.
Trial summary
1. Purpose and objective: Determine spectroscopic differences between tumor, dysplasia, and normal cutaneous tissue as assessed by histopathologic diagnosis. If successful, the optical measurements could be used to survey for and delineate the extent of malignancies in a noninvasive manner. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suspicious Skin Lesion(s) Requiring a Biopsy
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 3 Feb 2017
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who present to the Duke or VA Dermatology or Otolaryngology clinics with a suspicious skin lesion that is in need of a biopsy.
Who may be able to join
- Patients with at least one clinically suspicious skin lesion warranting a biopsy as part of routine care, in the outpatient clinic setting.
- Patients with previous histologically confirmed malignancy such as basal cell carcinoma or squamous cell carcinoma are eligible; however this is not required for enrollment.
- The suspicious skin lesion(s) is accessible to optical probe measurements. If patient has previous histologically confirmed malignancy of the skin, then the primary tumor site must be accessible to optical probe measurements
- Patient is able to provide written informed consent
- Patient is >18 years of age
Who cannot join
- < 18 years of age
- Unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Non-Invasive Optical Spectroscopy for Identification of Cutaneous Cancer
- Purpose and objective: Determine spectroscopic differences between tumor, dysplasia, and normal cutaneous tissue as assessed by histopathologic diagnosis. If successful, the optical measurements could be used to survey for and delineate the extent of malignancies in a noninvasive manner.
- Study activities and population group: Competent adults with a clinically suspicious skin lesion who are undergoing a biopsy as part of their routine care. For those who agree to participate, the sterilized portable optical spectroscopic probe will be used to measure diffuse reflectance on the lesion of clinical interest.
- Data analysis and risk/safety issues: The optical spectrometer does not breach any skin defense barrier. As this study involves noninvasive optical measurements of tissues, no significant safety concerns are anticipated. Qualitative analysis will be performed to describe whether there is correlation between spectroscopy measurements and pathologic diagnosis. A variety of correlative statistics will be explored to determine if there are relationships found that can justify a larger study
Read the detailed description
This is a pilot study to determine the optical spectroscopy characteristics of tumor in patients with cutaneous malignancies. These spectroscopy measurements will be compared with pathological diagnosis of tissue biopsies from the same site. If successful, the optical measurements could be used to survey for and delineate the extent of malignancies in a noninvasive manner. This would be especially helpful for clinic visits where suspicious lesions are seen and would otherwise require biopsy for diagnosis. Immediate benefits would include patients with numerous suspicious skin lesions who would require multiple biopsies.
Further spectroscopy measurements of the tumor site and adjacent normal tissue during therapy (chemoradiotherapy or radiotherapy) may provide useful information pertinent to tumor physiology and therapeutic effectiveness.
- Being tested
- No intervention; this is an observational study
- Keywords
- skin lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention; this is an observational studyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
spectroscopic differences between tumor, dysplasia, and normal cutaneous tissue.
Determine spectroscopic differences between tumor, dysplasia, and normal cutaneous tissue as assessed by histopathologic diagnosis.
Measured: 1 day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startMay 2016
- Primary completion3 Feb 2017
- Study completion3 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspicious Skin Lesion(s) Requiring a BiopsyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Woodard, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522793
- Sponsor's protocol ID
- Pro00058440
- Status last verified
- Jun 2017
- First submitted
- 12 Aug 2015
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Optical Spectroscopy for Identification of Cutaneous Cancer
- ClinicalTrials.gov ID
- NCT02522793
- Acronym / sponsor ID
- Pro00058440
- Keywords
- skin lesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- 3 Feb 2017 (actual)
- Study completion
- 3 Feb 2017 (actual)
- First posted
- 13 Aug 2015 (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.
- Purpose and objective: Determine spectroscopic differences between tumor, dysplasia, and normal cutaneous tissue as assessed by histopathologic diagnosis. If successful, the optical measurements could be used to survey for and delineate the extent of malignancies in a noninvasive manner.
- Study activities and population group: Competent adults with a clinically suspicious skin lesion who are undergoing a biopsy as part of their routine care. For those who agree to participate, the sterilized portable optical spectroscopic probe will be used to measure diffuse reflectance on the lesion of clinical interest.
- Data analysis and risk/safety issues: The optical spectrometer does not breach any skin defense barrier. As this study involves noninvasive optical measurements of tissues, no significant safety concerns are anticipated. Qualitative analysis will be performed to describe whether there is correlation between spectroscopy measurements and pathologic diagnosis. A variety of correlative statistics will be explored to determine if there are relationships found that can justify a larger study
Detailed description
This is a pilot study to determine the optical spectroscopy characteristics of tumor in patients with cutaneous malignancies. These spectroscopy measurements will be compared with pathological diagnosis of tissue biopsies from the same site. If successful, the optical measurements could be used to survey for and delineate the extent of malignancies in a noninvasive manner. This would be especially helpful for clinic visits where suspicious lesions are seen and would otherwise require biopsy for diagnosis. Immediate benefits would include patients with numerous suspicious skin lesions who would require multiple biopsies.
Further spectroscopy measurements of the tumor site and adjacent normal tissue during therapy (chemoradiotherapy or radiotherapy) may provide useful information pertinent to tumor physiology and therapeutic effectiveness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present to the Duke or VA Dermatology or Otolaryngology clinics with a suspicious skin lesion that is in need of a biopsy.
Key inclusion criteria (5 listed)
- Patients with at least one clinically suspicious skin lesion warranting a biopsy as part of routine care, in the outpatient clinic setting.
- Patients with previous histologically confirmed malignancy such as basal cell carcinoma or squamous cell carcinoma are eligible; however this is not required for enrollment.
- The suspicious skin lesion(s) is accessible to optical probe measurements. If patient has previous histologically confirmed malignancy of the skin, then the primary tumor site must be accessible to optical probe measurements
- Patient is able to provide written informed consent
- Patient is >18 years of age
Key exclusion criteria (2 listed)
- < 18 years of age
- Unable to provide written 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention; this is an observational study | Other | – |
Primary outcome
spectroscopic differences between tumor, dysplasia, and normal cutaneous tissue.
Time frame: 1 day visit
Determine spectroscopic differences between tumor, dysplasia, and normal cutaneous tissue as assessed by histopathologic diagnosis.
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 11 Jul 2017.
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.
Charles Woodard, MD principal investigator
Duke University
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 Suspicious Skin Lesion(s) Requiring a Biopsy, run by Duke University 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 5 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 11 Jul 2017. 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?
spectroscopic differences between tumor, dysplasia, and normal cutaneous tissue. (time frame: 1 day visit). 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 11 Jul 2017.