Efficiency of Presurgical Basal Cell Carcinoma Margin Map... | NCT03420846

Studies
Efficiency of Presurgical Basal Cell Carcinoma Margin Mapping

NCT03420846

Sponsor

Michelson Diagnostics Ltd.

Status

Terminated

Last Update Posted

Jan 28, 2020Actual

Enrollment

86Actual

Phase

Not Applicable

Conditions

Carcinoma, Basal Cell

Interventions

OCT Mapped

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding exhausted. Sufficient data already collected.

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Sep 1, 2019Actual

Completion Date

Sep 1, 2019Actual

First Submitted Date

Jan 29, 2018

First Submission Date that Met QC Criteria

Jan 29, 2018

First Posted Date

Feb 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2020

Last Update Posted Date

Jan 28, 2020Actual

Name	Class
Skin Care Network Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

86Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OCT Mapped arm	Experimental	OCT is used to map the tumour margins as the first stage MMS estimate	Other: OCT Mapped
Control arm	No Intervention	Standard MMS is performed

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OCT Mapped	Other	Presurgical mapping of Basal Cell Carcinoma margins	OCT Mapped arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Average number of Mohs stages	Is the average number of Mohs stages < 1.4 with a 95% confidence level. (P < 0.025)	1 day

Secondary Outcomes

Measure	Description	Time Frame
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	1 day
Average time taken to perform OCT margin mapping

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with biopsy-proven BCCs who have been referred for MMS

Exclusion Criteria:

Patients with BCCs larger than 6 cm2

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Howard Stevens	Skin Care Network Ltd.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SkinCare Network		London		SW10 9PJ	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Jan 19, 2018	Jan 29, 2018	ICF_000.pdf
Prot	Yes	No	No	Study Protocol	Jan 19, 2018	Jan 29, 2018	Prot_001.pdf

Condition Browse Module

MeSH Terms

ID	Term
D002280	Carcinoma, Basal Cell

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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.