NCT03420846

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

January 29, 2018

Last Update Submit

January 24, 2020

Conditions

Carcinoma, Basal Cell

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Size of the surgical defect

    1 day

  • Average time taken to perform OCT margin mapping

    1 day

Study Arms (2)

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

OCT MappedOTHER

Presurgical mapping of Basal Cell Carcinoma margins

OCT Mapped arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with BCCs larger than 6 cm2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SkinCare Network

London, SW10 9PJ, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Study Officials

  • Howard Stevens

    Skin Care Network Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2018

First Posted

February 5, 2018

Study Start

July 1, 2018

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)