Skin NeoplasmsNCT00390351
Investigate the Diagnostic Value and Possibilities of OCT in Non-Melanoma Skin Cancer.
An observational study of Skin Neoplasms, run by Zealand University Hospital at 2 sites in Denmark.
Trial summary
We will do systematic and functional assessment of non-melanoma skin cancer including precancerous lesions by OCT imaging and other diagnostic methods. The systematic assessment will be comparison of clinical diagnosis, histopathology, OCT images, spectrophotometry and high frequency ultrasound of non-melanoma skin… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Neoplasms
- What is being tested?
- optical coherence tomography
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 2 sitesDenmark
- Study dates
- Feb 2006to Jul 2008
- 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
Who may be able to join
- Patients above the age of 18 years with primary non-melanoma skin cancer NMSC or precancerous lesions from the Dermatology Department, and the Plastic Surgery Department at Roskilde Hospital, and from office based dermatologist in Roskilde County. Patients will only be recruited after informed consent.
Who cannot join
- Pregnancy.
- To avoid the potential bias of scar tissue in the OCT images we will not include OCT images from recurrent NMSC in this study.
- Patients will be excluded from the study if they are not able to give an informed consent. Staff from the Dermatology, Internal Medicine and Plastic Surgery Departments at RAS cannot be included in the phase I/phase 2 study.
- Gender: both
- Age limits: 18- no max
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 1 recruiting
- Suspended
Dept. of Dermatology, Copenhagen University
Dk-4000 Roskilde, 4000
- Recruiting
Roskilde Hospital
Roskilde, Roskilde, DK-4000
Mette Mogensen, MD, +45 4732 2116, rsmmog@ra.dk
Gregor BE Jemec, MD, DMSc, +45 4732 2022, rsgrj@ra.dk
About this study
Official title: Diagnosis of Non-Melanoma Skin Cancer With Optical Coherence Tomography
We will do systematic and functional assessment of non-melanoma skin cancer including precancerous lesions by OCT imaging and other diagnostic methods. The systematic assessment will be comparison of clinical diagnosis, histopathology, OCT images, spectrophotometry and high frequency ultrasound of non-melanoma skin cancer Functional exploration of non-melanoma skin cancer is done with Doppler-OCT and polarization-sensitive-OCT.
Read the detailed description
Optimal management of skin malignancies relies on early and accurate diagnosis. The reference standard in skin cancer is biopsy and histopathological assessment from a clinical suspicious skin lesion. The clinical diagnosis of skin cancer has sensitivity ranging from 50% to 90 % and specificity around 70% to 80% depending on the population studied and the experience of the clinician.
A rapid, non-invasive technique that could be used for characterization of skin lesions prior to biopsy would be valuable. In some patients with multiple, recurrent skin tumours the need for numerous biopsies in the same area is problematic, both cosmetically and diagnostically, as the cancer can be hidden under scar tissue.
The biopsy has several weaknesses: The biopsy must be done exactly in the tumour, and it does not delineate the tumour borders. Biopsy from skin is in general easy, but there are problematic places such as the T-zone in the face, the eyelids and the ears. Notably these places are areas where most types of skin cancer exhibit aggressive, invasive growth and have a high recurrence rate.
OCT is a novel, non-invasive optical imaging technology. It can provide cross-sectional tomographic images of tissue pathology in situ and in real time, without the need for excision and processing of specimens, as in conventional histopathology. OCT uses harmless, infrared light to create high-resolution images of tissue. OCT provides cross-sectional images of structures below the tissue surface in analogy to histopathology. Hence OCT can function as an "optical biopsy" providing images of tissue structure on the micron scale. For example, OCT could be used where standard excisional biopsy is hazardous or impossible, and OCT could reduce sampling errors associated with excisional biopsy.
- Conditions
- Skin Neoplasms
- Being tested
- optical coherence tomography
- Keywords
- Optical coherence tomography
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical coherence tomographyDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2006 (estimated)
- Study startFeb 2006
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin NeoplasmsStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe 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
- Defined population
- Time perspective
- Other
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mette Mogensen, MD, Principal investigator, Dept. of Dermatology, Roskilde HospitalGregor BE Jemec, MD, DMSc, Study director, Dept. of Dermatology, Roskilde Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390351
- Sponsor's protocol ID
- oct-MM-2005
- Other IDs
- Grant # BIOPHOT 26-02-0020
- Status last verified
- Oct 2006
- First submitted
- 18 Oct 2006
- Last updated
- 19 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Non-Melanoma Skin Cancer With Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT00390351
- Acronym / sponsor ID
- oct-MM-2005
- Conditions
- Skin Neoplasms
- Keywords
- Optical coherence tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Jul 2008
- First posted
- 19 Oct 2006 (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.
We will do systematic and functional assessment of non-melanoma skin cancer including precancerous lesions by OCT imaging and other diagnostic methods. The systematic assessment will be comparison of clinical diagnosis, histopathology, OCT images, spectrophotometry and high frequency ultrasound of non-melanoma skin cancer Functional exploration of non-melanoma skin cancer is done with Doppler-OCT and polarization-sensitive-OCT.
Detailed description
Optimal management of skin malignancies relies on early and accurate diagnosis. The reference standard in skin cancer is biopsy and histopathological assessment from a clinical suspicious skin lesion. The clinical diagnosis of skin cancer has sensitivity ranging from 50% to 90 % and specificity around 70% to 80% depending on the population studied and the experience of the clinician.
A rapid, non-invasive technique that could be used for characterization of skin lesions prior to biopsy would be valuable. In some patients with multiple, recurrent skin tumours the need for numerous biopsies in the same area is problematic, both cosmetically and diagnostically, as the cancer can be hidden under scar tissue.
The biopsy has several weaknesses: The biopsy must be done exactly in the tumour, and it does not delineate the tumour borders. Biopsy from skin is in general easy, but there are problematic places such as the T-zone in the face, the eyelids and the ears. Notably these places are areas where most types of skin cancer exhibit aggressive, invasive growth and have a high recurrence rate.
OCT is a novel, non-invasive optical imaging technology. It can provide cross-sectional tomographic images of tissue pathology in situ and in real time, without the need for excision and processing of specimens, as in conventional histopathology. OCT uses harmless, infrared light to create high-resolution images of tissue. OCT provides cross-sectional images of structures below the tissue surface in analogy to histopathology. Hence OCT can function as an "optical biopsy" providing images of tissue structure on the micron scale. For example, OCT could be used where standard excisional biopsy is hazardous or impossible, and OCT could reduce sampling errors associated with excisional biopsy.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients above the age of 18 years with primary non-melanoma skin cancer NMSC or precancerous lesions from the Dermatology Department, and the Plastic Surgery Department at Roskilde Hospital, and from office based dermatologist in Roskilde County. Patients will only be recruited after informed consent.
Key exclusion criteria (5 listed)
- Pregnancy.
- To avoid the potential bias of scar tissue in the OCT images we will not include OCT images from recurrent NMSC in this study.
- Patients will be excluded from the study if they are not able to give an informed consent. Staff from the Dermatology, Internal Medicine and Plastic Surgery Departments at RAS cannot be included in the phase I/phase 2 study.
- Gender: both
- Age limits: 18- no max
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 coherence tomography | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2006.
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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.
Mette Mogensen, MD principal investigator
Dept. of Dermatology, Roskilde Hospital
Gregor BE Jemec, MD, DMSc study director
Dept. of Dermatology, Roskilde Hospital
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 Neoplasms, run by Zealand University Hospital at 2 sites in Denmark.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Oct 2006. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mette Mogensen, MD (+45 4732 2116, rsmmog@ra.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 19 Oct 2006.