Basal Cell Carcinoma of the SkinECOBASONCT06271603
Evaluation of the Efficiency and Economic Impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the Diagnosis and Management of Basal Cell Carcinomas
A study testing diagnosis based on deepLive™ LC-OCT device and diagnosis based on skin biopsy in people with Basal Cell Carcinoma of the Skin, run by Damae Medical at 1 site in France.
Trial summary
This is a comparative, randomized, prospective, multicenter clinical investigation aimed at evaluating the efficiency and economic impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the diagnosis and management of basal cell carcinomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma of the Skin
- What is being tested?
- diagnosis based on deepLive™ LC-OCT device and diagnosis based on skin biopsy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 704 participants
- Where
- 1 siteFrance
- Study dates
- 26 Feb 2024to Feb 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with one or more clinically suspicious lesions of BCC for which:
- The diagnosis is uncertain following clinical and dermoscopic examination, and diagnostic biopsy is necessary according to the latest European guidelines from EADO.
- And/or for which the knowledge of the histological subtype determines the subsequent management.
- And/or for which diagnostic biopsy is necessary in the standard practice to confirm the clinical diagnosis (peri-orificial facial lesions, any lesion that may require complex surgical reconstruction).
Who cannot join
- The lesion is suspected to be a recurrent BCC.
- The suspicious lesion has been previously treated by other surgical or non-surgical methods (cryotherapy, topical treatment, PDT, etc.).
- Lesions within 3 cm of the eye.
- Presence of cutaneous comorbidities that could interfere with a proper evaluation of the studied lesion according to the investigator.
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Ambroise Paré
Boulogne-Billancourt, 92100
Professeur Philippe SAIAG, 800-555-5555, philippe.saiag@uvsq.fr
Philippe SAIAG
About this study
Official title: Evaluation of the Efficiency and Economic Impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the Diagnosis and Management of Basal Cell Carcinomas (ECOBASO)
This is a comparative, randomized, prospective, multicenter clinical investigation aimed at evaluating the efficiency and economic impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the diagnosis and management of basal cell carcinomas.
Read the detailed description
Basal cell carcinoma (BCC) is the most common type of skin cancer. The diagnosis and subtyping of suspicious lesions can be challenging for certain \"equivocal\" lesions where clinical and dermoscopic criteria do not allow for a definite diagnosis or subtyping, which determines the treatment. The most commonly used technique for the diagnosis and selection of appropriate treatment for BCC is skin biopsy. Microscopic imaging techniques allow for \"optical\" biopsies, which appear as an attractive alternative to traditional biopsies.
The deepLive™ device integrates LC-OCT (Line-field Confocal Optical Coherence Tomography), which is a novel microscopic imaging technology with unmatched imaging performance to date, including cellular isotropic resolution (1 μm), a penetration depth of 500 μm, and the ability to obtain real-time cross-sectional and 3D images in the same orientation as histology. Numerous multicenter studies have confirmed the high performance of this technique for the diagnosis and subtyping of BCC. However, its usefulness in the diagnostic and treatment management of BCC has not been investigated prospectively. This clinical investigation is based on the hypothesis that the use of the deepLive™ device will enable diagnostic and therapeutic management by reducing the number of consultations/procedures without compromising patient outcomes compared to a traditional management approach with biopsy(ies). This strategy could optimize the entire care pathway by reducing invasive diagnostic or therapeutic procedures and freeing up dermatological resources for other procedures. This optimization of the care pathway is expected to result in a favorable economic impact on the healthcare system.
- Conditions
- Basal Cell Carcinoma of the Skin
- Being tested
- diagnosis based on deepLive™ LC-OCT device, diagnosis based on skin biopsy
- Keywords
- basal cell carcinoma diagnosis, LC-OCT
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosis based on deepLive™ LC-OCT deviceDiagnostic test
Also called LC-OCT arm
Management of BCC with an initial diagnosis based on the deepLive™ device using LC-OCT technology.
diagnosis based on skin biopsyDiagnostic test
Also called biopsy arm
Control Arm: Standard management with an initial diagnosis based on skin biopsy
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm: Management performed with an initial diagnosis based on the LC-OCT device | Experimental | The interventional procedure involves the management of BCC with an initial diagnosis based on the deepLive™ device. The imaging is performed by placing the probe tip in contact with the patient\'s skin after applying an immersion oil (paraffin) to the imaging area. The examination lasts only a few minutes and is painless. An integrated dermoscopic targeting system allows the operator to ensure proper positioning of the probe on the lesion and to ensure that the entire lesion has been captured for an accurate diagnosis. The images are displayed in real-time during the examination and directly evaluated by the investigator, who has the option to save images/videos at their discretion. A final evaluation with the deepLive™ device will also be performed during the 1-year follow-up, and intermediate evaluations may also be performed with the deepLive™ device depending on the initial management of BCC. Receives: Diagnostic Test: diagnosis based on deepLive™ LC-OCT device |
| Control Arm: Standard management with an initial diagnosis based on skin biopsy | Active comparator | The control procedure corresponds to standard management of BCC with an initial diagnosis based on skin biopsy (standard management arm). The biopsy will be performed according to the standard practice of each center, using a 2 to 6 mm punch or shave biopsy, with prior injection of a local anesthetic. A final evaluation with the deepLive™ device will also be performed during the 1-year follow-up. Receives: Diagnostic Test: diagnosis based on skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management.
The primary objective is defined by a family of primary criteria that will be tested sequentially in a hierarchical manner. The clinical non-inferiority will be assessed by the proportion of success which is defined as the absence of residual or recurrent cancerous or precancerous lesions after 1 year of primary BCC through diagnosis with LC-OCT, as compared to traditional management.
Measured: from enrollment to the 1 year follow up
The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management.
The primary objective is defined by a family of primary criteria that will be tested sequentially in a hierarchical manner. Organizational effectiveness will be evaluated by measuring the total time spent by dermatologists and pathologists (in hours) for managing primary BCC through diagnosis with LC-OCT, as compared to traditional management.
Measured: from enrollment to the 1 year follow up
The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management.
The primary objective is defined by a family of primary criteria that will be tested sequentially in a hierarchical manner. Economic superiority will be assessed by comparing the total cost of management (€) of primary BCC through diagnosis with LC-OCT to traditional management.
Measured: from enrollment to the 1 year follow up
Secondary outcomes (8)
Compare, after the diagnosis announcement and at 1 year, the quality of life of patients in the LC-OCT arm versus the standard management arm.
Quality of life will be assessed using the EQ-5D-5L questionnaire
Measured: from enrollment to the 1 year follow up
Compare, after the diagnosis announcement and at 1 year, the anxiety levels of patients in the LC-OCT arm versus the standard management arm.
Anxiety will be assessed using a visual analog scale (score 0 - 10)
Measured: from enrollment to the 1 year follow up
Compare patient satisfaction with their management at 1 year in the LC-OCT arm versus the standard management arm.
Patient satisfaction will be evaluated using a Likert scale focused on the overall management of the cutaneous lesion.
Measured: from enrollment to the 1 year follow up
Evaluate the performance of LC-OCT for the diagnosis and subtyping of BCC for all patients operated on or biopsied in the LC-OCT arm.
Performance will be evaluated based on the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR), negative likelihood ratio (NLR), and accuracy of LC-OCT for the diagnosis and subtyping of BCC in all patients operated on or biopsied in the LC-OCT arm, using histological diagnosis as the gold standard.
Measured: from enrollment to the 1 year follow up
Compare dermatologists' satisfaction with patient management in the LC-OCT arm versus the standard management arm
Physician satisfaction will be evaluated using a Likert scale focused on the overall management of the cutaneous lesion.
Measured: from enrollment to the 1 year follow up
Estimate the actual cost of conducting the diagnosis with LC-OCT technology.
Actual cost (€) of conducting the diagnosis with deepLive™ measured using micro-costing methodology
Measured: from enrollment to the 1 year follow up
Compare healthcare consumption between the two groups at 1 year.
Typology of healthcare consumption at 1 year in each group to identify differences between the two groups in terms of: consultations, treatments, hospitalizations, medical procedures, laboratory tests, imaging, etc.
Measured: from enrollment to the 1 year follow up
Conduct a cost-consequence analysis of patient management with LC-OCT technology versus standard management.
The descriptive cost-consequence analysis will analyze the difference in patient management costs at 1 year in relation to the impacts of deepLive™ on other clinical and organizational criteria.
Measured: from enrollment to the 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start26 Feb 2024 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell Carcinoma of the SkinStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 704 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Damae Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271603
- Sponsor's protocol ID
- 23.02645.000357-MS01
- Other IDs
- CPP Ile de France III
- Acronym
- ECOBASO
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency and Economic Impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the Diagnosis and Management of Basal Cell Carcinomas (ECOBASO)
- ClinicalTrials.gov ID
- NCT06271603
- Acronym / sponsor ID
- ECOBASO / 23.02645.000357-MS01
- Conditions
- Basal Cell Carcinoma of the Skin
- Keywords
- basal cell carcinoma diagnosis, LC-OCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 704 participants (estimated)
- Lead sponsor
- Damae MedicalIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2024 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 22 Feb 2024 (actual)
- 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 is a comparative, randomized, prospective, multicenter clinical investigation aimed at evaluating the efficiency and economic impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the diagnosis and management of basal cell carcinomas.
Detailed description
Basal cell carcinoma (BCC) is the most common type of skin cancer. The diagnosis and subtyping of suspicious lesions can be challenging for certain \"equivocal\" lesions where clinical and dermoscopic criteria do not allow for a definite diagnosis or subtyping, which determines the treatment. The most commonly used technique for the diagnosis and selection of appropriate treatment for BCC is skin biopsy. Microscopic imaging techniques allow for \"optical\" biopsies, which appear as an attractive alternative to traditional biopsies.
The deepLive™ device integrates LC-OCT (Line-field Confocal Optical Coherence Tomography), which is a novel microscopic imaging technology with unmatched imaging performance to date, including cellular isotropic resolution (1 μm), a penetration depth of 500 μm, and the ability to obtain real-time cross-sectional and 3D images in the same orientation as histology. Numerous multicenter studies have confirmed the high performance of this technique for the diagnosis and subtyping of BCC. However, its usefulness in the diagnostic and treatment management of BCC has not been investigated prospectively. This clinical investigation is based on the hypothesis that the use of the deepLive™ device will enable diagnostic and therapeutic management by reducing the number of consultations/procedures without compromising patient outcomes compared to a traditional management approach with biopsy(ies). This strategy could optimize the entire care pathway by reducing invasive diagnostic or therapeutic procedures and freeing up dermatological resources for other procedures. This optimization of the care pathway is expected to result in a favorable economic impact on the healthcare system.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm: Management performed with an initial diagnosis based on the LC-OCT device | Experimental | Diagnostic Test: diagnosis based on deepLive™ LC-OCT deviceThe interventional procedure involves the management of BCC with an initial diagnosis based on the deepLive™ device. The imaging is performed by placing the probe tip in contact with the patient\'s skin after applying an immersion oil (paraffin) to the imaging area. The examination lasts only a few minutes and is painless. An integrated dermoscopic targeting system allows the operator to ensure proper positioning of the probe on the lesion and to ensure that the entire lesion has been captured for an accurate diagnosis. The images are displayed in real-time during the examination and directly evaluated by the investigator, who has the option to save images/videos at their discretion. A final evaluation with the deepLive™ device will also be performed during the 1-year follow-up, and intermediate evaluations may also be performed with the deepLive™ device depending on the initial management of BCC. |
| Control Arm: Standard management with an initial diagnosis based on skin biopsy | Active comparator | Diagnostic Test: diagnosis based on skin biopsyThe control procedure corresponds to standard management of BCC with an initial diagnosis based on skin biopsy (standard management arm). The biopsy will be performed according to the standard practice of each center, using a 2 to 6 mm punch or shave biopsy, with prior injection of a local anesthetic. A final evaluation with the deepLive™ device will also be performed during the 1-year follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The diagnosis is uncertain following clinical and dermoscopic examination, and diagnostic biopsy is necessary according to the latest European guidelines from EADO.
- And/or for which the knowledge of the histological subtype determines the subsequent management.
- And/or for which diagnostic biopsy is necessary in the standard practice to confirm the clinical diagnosis (peri-orificial facial lesions, any lesion that may require complex surgical reconstruction).
Key exclusion criteria (4 listed)
- The lesion is suspected to be a recurrent BCC.
- The suspicious lesion has been previously treated by other surgical or non-surgical methods (cryotherapy, topical treatment, PDT, etc.).
- Lesions within 3 cm of the eye.
- Presence of cutaneous comorbidities that could interfere with a proper evaluation of the studied lesion according to the investigator.
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 |
|---|---|---|
| diagnosis based on deepLive™ LC-OCT deviceAlso: LC-OCT armManagement of BCC with an initial diagnosis based on the deepLive™ device using LC-OCT technology. | Diagnostic test | Intervention Arm: Management performed with an initial diagnosis based on the LC-OCT device |
| diagnosis based on skin biopsyAlso: biopsy armControl Arm: Standard management with an initial diagnosis based on skin biopsy | Diagnostic test | Control Arm: Standard management with an initial diagnosis based on skin biopsy |
Primary outcome
The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management.
Time frame: from enrollment to the 1 year follow up
The primary objective is defined by a family of primary criteria that will be tested sequentially in a hierarchical manner. The clinical non-inferiority will be assessed by the proportion of success which is defined as the absence of residual or recurrent cancerous or precancerous lesions after 1 year of primary BCC through diagnosis with LC-OCT, as compared to traditional management.
The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management.
Time frame: from enrollment to the 1 year follow up
The primary objective is defined by a family of primary criteria that will be tested sequentially in a hierarchical manner. Organizational effectiveness will be evaluated by measuring the total time spent by dermatologists and pathologists (in hours) for managing primary BCC through diagnosis with LC-OCT, as compared to traditional management.
The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management.
Time frame: from enrollment to the 1 year follow up
The primary objective is defined by a family of primary criteria that will be tested sequentially in a hierarchical manner. Economic superiority will be assessed by comparing the total cost of management (€) of primary BCC through diagnosis with LC-OCT to traditional management.
8 secondary outcomes
Compare, after the diagnosis announcement and at 1 year, the quality of life of patients in the LC-OCT arm versus the standard management arm.
Time frame: from enrollment to the 1 year follow up
Compare, after the diagnosis announcement and at 1 year, the anxiety levels of patients in the LC-OCT arm versus the standard management arm.
Time frame: from enrollment to the 1 year follow up
Compare patient satisfaction with their management at 1 year in the LC-OCT arm versus the standard management arm.
Time frame: from enrollment to the 1 year follow up
Evaluate the performance of LC-OCT for the diagnosis and subtyping of BCC for all patients operated on or biopsied in the LC-OCT arm.
Time frame: from enrollment to the 1 year follow up
Compare dermatologists' satisfaction with patient management in the LC-OCT arm versus the standard management arm
Time frame: from enrollment to the 1 year follow up
Estimate the actual cost of conducting the diagnosis with LC-OCT technology.
Time frame: from enrollment to the 1 year follow up
Compare healthcare consumption between the two groups at 1 year.
Time frame: from enrollment to the 1 year follow up
Conduct a cost-consequence analysis of patient management with LC-OCT technology versus standard management.
Time frame: from enrollment to the 1 year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diagnosis based on deepLive™ LC-OCT device and diagnosis based on skin biopsy in people with Basal Cell Carcinoma of the Skin, run by Damae Medical at 1 site in France.
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 4 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 22 Feb 2024. 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 France. 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 Philippe Saiag (800-555-5555, philippe.saiag@uvsq.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management. (time frame: from enrollment to the 1 year follow up). The study lists 3 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 22 Feb 2024.