NCT05853315

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
451

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

3.4 years

First QC Date

May 2, 2023

Last Update Submit

May 14, 2023

Conditions

Basal Cell CarcinomaEye DiseasesEye Cancer

Outcome Measures

Primary Outcomes (1)

  • BCC Recurrence

    mean 3-5 years

Interventions

SurgeryPROCEDURE

Surgical Excision

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

male and female patients with periocular basal cell carcinoma

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Carcinoma, Basal CellEye DiseasesEye Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellNeoplasms by Site

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priv. Doz. Dr.

Study Record Dates

First Submitted

May 2, 2023

First Posted

May 10, 2023

Study Start

November 12, 2019

Primary Completion

April 1, 2023

Study Completion

May 1, 2023

Last Updated

May 16, 2023

Record last verified: 2023-05

Locations

AU(1)