BCC Excision Revisited | NCT05853315

Studies
BCC Excision Revisited

NCT05853315

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

May 16, 2023Actual

Enrollment

451Actual

Phase

Not provided

Conditions

Basal Cell Carcinoma
Eye Diseases
Eye Cancer

Interventions

Surgery

Countries

Austria

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

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 12, 2019Actual

Primary Completion Date

Apr 1, 2023Actual

Completion Date

May 1, 2023Actual

First Submitted Date

May 2, 2023

First Submission Date that Met QC Criteria

May 2, 2023

First Posted Date

May 10, 2023Actual

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

May 14, 2023

Last Update Posted Date

May 16, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To readdress basal cell carcinoma (BCC) in the periocular region to prove histologically controlled surgical treatment efficacy and to identify high-risk characteristics.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

451Actual

Name	Type	Description	Arm Group Labels	Other Names
Surgery	Procedure	Surgical Excision

Measure	Description	Time Frame
BCC Recurrence		mean 3-5 years

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Patient records were reviewed for the presence of BCC and surgical excision with frozen sections control of the wound margins in the periocular region,
conducted between 01.01.2009 and 31.12.2019.
Periocular was defined as the area involving the medial and lateral canthus as well as the upper and lower eyelids.

Exclusion criteria:

BCCs outside of this region were excluded from this analysis,
as well as incomplete records.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

male and female patients with periocular basal cell carcinoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna		Vienna		1090	Austria

Condition Browse Module

MeSH Terms

ID	Term
D002280	Carcinoma, Basal Cell
D005128	Eye Diseases
D005134	Eye Neoplasms

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 Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided