Carcinoma, Basal CellNCT03420846
Efficiency of Presurgical Basal Cell Carcinoma Margin Mapping
A study testing OCT Mapped in people with Carcinoma, Basal Cell, run by Michelson Diagnostics Ltd. at 1 site in United Kingdom.
Trial summary
This Interventional Randomised Controlled study is intended to establish that presurgical margin mapping of BCCs with OCT results in a reduction of the number of MMS surgery stages without adversely impacting clinical outcome, resulting in shorter patient stays and more efficient use of surgical and operating room… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carcinoma, Basal Cell
- What is being tested?
- OCT Mapped
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2018to 1 Sep 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with biopsy-proven BCCs who have been referred for MMS
Who cannot join
- Patients with BCCs larger than 6 cm2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficiency of Presurgical Basal Cell Carcinoma Margin Mapping Using Optical Coherence Tomography
This Interventional Randomised Controlled study is intended to establish that presurgical margin mapping of BCCs with OCT results in a reduction of the number of MMS surgery stages without adversely impacting clinical outcome, resulting in shorter patient stays and more efficient use of surgical and operating room resources.
Read the detailed description
Basal Cell Carcinoma (BCC) is the most common malignancy in humans. Its incidence is continuously increasing. The head and neck areas are most commonly affected due to their increased lifetime exposure to sun compared to other body parts. BCC is often treated by surgical excision which has high cure rate compared to other treatment modalities, but leaves a visible scar which can affect the quality of life of the patient, depending on the location and size of the excision. Mohs Micrographic Surgery (MMS) was developed to minimize the size of the surgical excision whilst maintaining very high cure rate. The main drawback of MMS is that repeated surgery procedures are usually required to eliminate all of the tumour using specialist resources located at the clinic.
Optical Coherence Tomography (OCT) allows non-invasive in-vivo imaging of superficial skin lesions. It is in routine clinical use for diagnosis of BCCs, and the diagnostic sensitivity and specificity is well established in published multi-centre trials. A further potential application of OCT is the pre-surgical mapping of the lateral margins of BCC. If the margins of a BCC were accurately known prior to commencing an MMS treatment, the treatment could be performed much more quickly, resulting in shorter patient stays and more efficient use of surgical and operating room resources. Previously published research has already shown that OCT mapping of BCC margins is more accurate than clinical assessment; the objective of the present study is to demonstrate that pre-surgical mapping of BCC margins with OCT is also more efficient.
- Conditions
- Carcinoma, Basal Cell
- Being tested
- OCT Mapped
- 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.
OCT MappedOther
Presurgical mapping of Basal Cell Carcinoma margins
| Study group | Role | What they receive |
|---|---|---|
| OCT Mapped arm | Experimental | OCT is used to map the tumour margins as the first stage MMS estimate Receives: Other: OCT Mapped |
| Control arm | No intervention | Standard MMS is performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average number of Mohs stages
Is the average number of Mohs stages < 1.4 with a 95% confidence level. (P < 0.025)
Measured: 1 day
Secondary outcomes (2)
Size of the surgical defect
Validate that the reduction in MMS stages by use of OCT mapping does not result in an increase in the size of the surgical defect
Measured: 1 day
Average time taken to perform OCT margin mapping
Show that the average time taken to perform OCT margin mapping is < 5 minutes for lesions of area < 2 cm2
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Jul 2018
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Why it stopped: Funding exhausted. Sufficient data already collected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Basal CellStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to two arms. Participants in the first arm receive Mohs surgery using OCT mapping to delineate tumor margins. Participants in the Control Arm receive Mohs surgery using clinical estimation of tumor margins (ie. standard care) The average number of Mohs surgery cycles will be compared for the two arms.
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michelson Diagnostics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Skin Care Network Ltd.
- Responsible party
- Sponsor
- Investigators
- Howard Stevens, Principal investigator, Skin Care Network Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420846
- Sponsor's protocol ID
- 1202
- Status last verified
- Jan 2020
- First submitted
- 29 Jan 2018
- Last updated
- 28 Jan 2020
- 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 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Presurgical Basal Cell Carcinoma Margin Mapping Using Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT03420846
- Acronym / sponsor ID
- 1202
- Conditions
- Carcinoma, Basal Cell
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding exhausted. Sufficient data already collected.
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Michelson Diagnostics Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Skin Care Network Ltd.
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 5 Feb 2018 (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 Interventional Randomised Controlled study is intended to establish that presurgical margin mapping of BCCs with OCT results in a reduction of the number of MMS surgery stages without adversely impacting clinical outcome, resulting in shorter patient stays and more efficient use of surgical and operating room resources.
Detailed description
Basal Cell Carcinoma (BCC) is the most common malignancy in humans. Its incidence is continuously increasing. The head and neck areas are most commonly affected due to their increased lifetime exposure to sun compared to other body parts. BCC is often treated by surgical excision which has high cure rate compared to other treatment modalities, but leaves a visible scar which can affect the quality of life of the patient, depending on the location and size of the excision. Mohs Micrographic Surgery (MMS) was developed to minimize the size of the surgical excision whilst maintaining very high cure rate. The main drawback of MMS is that repeated surgery procedures are usually required to eliminate all of the tumour using specialist resources located at the clinic.
Optical Coherence Tomography (OCT) allows non-invasive in-vivo imaging of superficial skin lesions. It is in routine clinical use for diagnosis of BCCs, and the diagnostic sensitivity and specificity is well established in published multi-centre trials. A further potential application of OCT is the pre-surgical mapping of the lateral margins of BCC. If the margins of a BCC were accurately known prior to commencing an MMS treatment, the treatment could be performed much more quickly, resulting in shorter patient stays and more efficient use of surgical and operating room resources. Previously published research has already shown that OCT mapping of BCC margins is more accurate than clinical assessment; the objective of the present study is to demonstrate that pre-surgical mapping of BCC margins with OCT is also more efficient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to two arms. Participants in the first arm receive Mohs surgery using OCT mapping to delineate tumor margins. Participants in the Control Arm receive Mohs surgery using clinical estimation of tumor margins (ie. standard care) The average number of Mohs surgery cycles will be compared for the two arms.
| Arm | Type | Receives |
|---|---|---|
| OCT Mapped arm | Experimental | Other: OCT MappedOCT is used to map the tumour margins as the first stage MMS estimate |
| Control arm | No intervention | –Standard MMS is performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with biopsy-proven BCCs who have been referred for MMS
Key exclusion criteria (1 listed)
- Patients with BCCs larger than 6 cm2
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 |
|---|---|---|
| OCT MappedPresurgical mapping of Basal Cell Carcinoma margins | Other | OCT Mapped arm |
Primary outcome
Average number of Mohs stages
Time frame: 1 day
Is the average number of Mohs stages < 1.4 with a 95% confidence level. (P < 0.025)
2 secondary outcomes
Size of the surgical defect
Time frame: 1 day
Average time taken to perform OCT margin mapping
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Funding exhausted. Sufficient data already collected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Carcinoma, Basal Cell
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
A Study Comparing Cemiplimab-based Treatments for Adult Participants With Locally Advanced Basal Cell Skin Cancer (laBCC)
Locally Advanced Basal Cell Carcinoma
Enrolling by invitation
TruScore Standalone Clinical Study
Melanoma and Other Malignant Neoplasms of Skin, Basal Cell Carcinoma of Skin
Not yet recruiting
Plasmonic PhotoThermal Therapy (PPTT) With Glucose-Coated Gold Nanoparticles (TSK-001) in Patients With Nodular Basal Cell Carcinoma (nBCC)
Nodular BCC
RecruitingObservational study
Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice
Basal Cell Carcinoma of Skin, Optical Coherence Tomography (OCT)
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.
Howard Stevens principal investigator
Skin Care Network Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT Mapped in people with Carcinoma, Basal Cell, run by Michelson Diagnostics Ltd. at 1 site in United Kingdom.
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 1 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: stopped early, as of the sponsor's last update on 28 Jan 2020. 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 Kingdom. 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 was stopped early (reason given: Funding exhausted. Sufficient data already collected.). Results are not available in the source record.
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?
Average number of Mohs stages (time frame: 1 day). 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 28 Jan 2020; AzTrials last refreshed its copy on 1 Nov 2026.