Mixed Tumor, MalignantOCTSKINNCT02851693
Study of Imaging Characteristics OCT of Skin Lesions Requiring Biopsy / Resection
A study testing Optical Coherence Tomography (OCT) with Vivosight and Optical Coherence Tomography (OCT) with Skintell in people with Mixed Tumor, Malignant and Biopsy, run by Centre Hospitalier Universitaire de Saint Etienne.
Trial summary
The diagnosis of cutaneous lesions often involves the use of surgical and invasive procedures such as biopsy or excision in order to analyze the structure and appearance of the fabric pathologists. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mixed Tumor, Malignant, Biopsy, Resection
- What is being tested?
- Optical Coherence Tomography (OCT) with Vivosight and Optical Coherence Tomography (OCT) with Skintell
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 1 Dec 2017
- Phase
- Interventional
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with suspicious skin lesions of malignant tumor (mostly non-melanoma: basal cell carcinoma, epidermoid carcinoma and actinic keratoses, or melanoma: melanoma, nevi) requiring biopsy / surgical excision;
- consent signed
Who cannot join
- Any dermatosis, hyperalgesic lesion, and / or infected and / or topography making it impossible measurements;
- pregnant and nursing women
- patients under tutorship or curatorship
About this study
The diagnosis of cutaneous lesions often involves the use of surgical and invasive procedures such as biopsy or excision in order to analyze the structure and appearance of the fabric pathologists. With recent advances in optical and electronic fields, considerable efforts were produced to build high-performance optical instruments, able to transcribe the internal structure of the skin with varying degrees of depth and variable resolution.
The imagery is now an area of great interest for medical diagnosis: non-invasive, quick, and in real time. This area is booming and new optical instruments are created to eventually be able to offer a reliable alternative to invasive techniques.
Read more
The optical properties of different tissues have been studied for several years by different research groups: the coefficient of light absorption by the tissue both in vivo and in vitro, the coefficient of light scattering or the index refractive were characterized in various tissues that make up the skin.
Other studies have focused on melanoma detection by multispectral optical techniques, or via the technique of optical coherence tomography (OCT) performed on lesions suspicious for cancer, but without linking criteria between these two techniques.
However, no study to date and to our knowledge has been able to demonstrate the different optical parameters obtained with OCT and can be directly connected to known and histopathological parameters commonly used in the diagnosis of lesions skin. This study aims to verify if it is possible to determine the parameters measured in OCT that would discriminate between benign and malignant lesions.
- Conditions
- Mixed Tumor, Malignant, Biopsy, Resection, Carcinoma, Keratosis
- Being tested
- Optical Coherence Tomography (OCT) with Vivosight, Optical Coherence Tomography (OCT) with Skintell
- Medical subject headings
- Mixed Tumor, Malignant, Carcinoma, Keratosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography (OCT) with VivosightDevice
Also called VIVOSIGHT (Michelson Diagnostics Ltd, Maidstone, Kent, UK)
OCT used is Vivosight for diagnosis
Optical Coherence Tomography (OCT) with SkintellDevice
Also called SKINTELL (Agfa HealthCare, Heverlee, Belgium)
OCT used is Skintell for diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Optical Coherence Tomography (OCT) | Experimental | Not described Receives: Device: Optical Coherence Tomography (OCT) with Vivosight; Device: Optical Coherence Tomography (OCT) with Skintell |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite endpoint
thickness of the epidermis (µm), thickness of the dermis (µm), limit of epidermis/dermis, homogeneity of the epidermis, homogeneity and structure of the papillary dermis, vascular network associated, homogeneity of the reticular dermis, wall of vacuoles and nodules (presence or absence)
Measured: at baseline
Secondary outcomes (4)
implementation duration
minutes
Measured: at baseline
acquisition practices duration
minutes
Measured: at baseline
the duration of analysis image
minutes
Measured: at baseline
utility of labeling with a dye for histology to locate the lesion
yes or no
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study start1 Jun 2016
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Why it stopped: No open study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed Tumor, MalignantStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France
- Responsible party
- Sponsor
- Investigators
- Jean Luc PERROT, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851693
- Sponsor's protocol ID
- 1608069
- Other IDs
- 2016-A00647-44
- Acronym
- OCTSKIN
- Status last verified
- Mar 2019
- First submitted
- 28 Jul 2016
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Imaging Characteristics OCT of Skin Lesions Requiring Biopsy / Resection
- ClinicalTrials.gov ID
- NCT02851693
- Acronym / sponsor ID
- OCTSKIN / 1608069
- Conditions
- Mixed Tumor, Malignant, Biopsy, Resection, Carcinoma, Keratosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No open study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- National Research Agency, France
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 2 Aug 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 diagnosis of cutaneous lesions often involves the use of surgical and invasive procedures such as biopsy or excision in order to analyze the structure and appearance of the fabric pathologists. With recent advances in optical and electronic fields, considerable efforts were produced to build high-performance optical instruments, able to transcribe the internal structure of the skin with varying degrees of depth and variable resolution.
The imagery is now an area of great interest for medical diagnosis: non-invasive, quick, and in real time. This area is booming and new optical instruments are created to eventually be able to offer a reliable alternative to invasive techniques.
The optical properties of different tissues have been studied for several years by different research groups: the coefficient of light absorption by the tissue both in vivo and in vitro, the coefficient of light scattering or the index refractive were characterized in various tissues that make up the skin.
Other studies have focused on melanoma detection by multispectral optical techniques, or via the technique of optical coherence tomography (OCT) performed on lesions suspicious for cancer, but without linking criteria between these two techniques.
However, no study to date and to our knowledge has been able to demonstrate the different optical parameters obtained with OCT and can be directly connected to known and histopathological parameters commonly used in the diagnosis of lesions skin. This study aims to verify if it is possible to determine the parameters measured in OCT that would discriminate between benign and malignant lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optical Coherence Tomography (OCT) | Experimental | Device: Optical Coherence Tomography (OCT) with Vivosight, Device: Optical Coherence Tomography (OCT) with Skintell |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with suspicious skin lesions of malignant tumor (mostly non-melanoma: basal cell carcinoma, epidermoid carcinoma and actinic keratoses, or melanoma: melanoma, nevi) requiring biopsy / surgical excision;
- consent signed
Key exclusion criteria (3 listed)
- Any dermatosis, hyperalgesic lesion, and / or infected and / or topography making it impossible measurements;
- pregnant and nursing women
- patients under tutorship or curatorship
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 (OCT) with VivosightAlso: VIVOSIGHT (Michelson Diagnostics Ltd, Maidstone, Kent, UK)OCT used is Vivosight for diagnosis | Device | Optical Coherence Tomography (OCT) |
| Optical Coherence Tomography (OCT) with SkintellAlso: SKINTELL (Agfa HealthCare, Heverlee, Belgium)OCT used is Skintell for diagnosis | Device | Optical Coherence Tomography (OCT) |
Primary outcome
composite endpoint
Time frame: at baseline
thickness of the epidermis (µm), thickness of the dermis (µm), limit of epidermis/dermis, homogeneity of the epidermis, homogeneity and structure of the papillary dermis, vascular network associated, homogeneity of the reticular dermis, wall of vacuoles and nodules (presence or absence)
4 secondary outcomes
implementation duration
Time frame: at baseline
acquisition practices duration
Time frame: at baseline
the duration of analysis image
Time frame: at baseline
utility of labeling with a dye for histology to locate the lesion
Time frame: at baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 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.
Jean Luc PERROT, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
Questions about this trial
What is this clinical trial studying?
A study testing Optical Coherence Tomography (OCT) with Vivosight and Optical Coherence Tomography (OCT) with Skintell in people with Mixed Tumor, Malignant and Biopsy, run by Centre Hospitalier Universitaire de Saint Etienne.
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 3 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: withdrawn, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
composite endpoint (time frame: at baseline). 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 4 Apr 2019.