Observational Study of Correlation Between Recurrent Basal Cell Carcinoma and Localisation

Observational Study of Basal Cell Carcinoma Operated at Montpellier University Hospital and Millau Hospital From February 2020 to February 2021 - Study of Correlation Between Localisation and Recurrence, and Other Criterias

.During one year all the resected basal cell carcinomas (BCC) analyzed in Montpellier University Hospital Anatomopathology unit were included in this study. Localisation and histological characteristics were collected. All the recurrences of BCC were searched from the medical records (or histopathology request form).

From 804 BCC, 48 were recurrent BCC with or without complete first resection. Patients with recurrent BCC were contacted to obtain agreement and more informations about the first resection and some clinical informations like sun exposure and phototype.

The statistical analysis focused on the localisation of recurrent BCC (with a complete first resection) compared to localisations of primary BCC in this population. The goal was to identified localisations with an increased risk of recurrences.

Study Overview

• Status: Completed
• Conditions: Basal Cell Carcinoma

• Study Type: Observational
• Enrollment (Actual): 804

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cohort :

All the resected BCC during one year in Montpellier University Hospital and Millau Hospital (both analyzed in anatomopathology unit in Montpellier University Hospital).

Cases :

All the cases of recurrent BCC, found after research in medical records or histopathology request form.

Description

Cohort :

Inclusion criteria:

- Patients with resected BCC

Exclusion criteria:

• Biopsies of BCC,
• revised surgery of incomplete resection.

Cases :

Inclusion criteria:

-Recurrent BCC with complete first resection

Exclusion criteria:

- Recurrent BCC with incomplete first resection, Patients with Gorlin syndrome (a genetic disease that increase risk of BCC)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
recurrent BCC
resected BCC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
- Determined For each localisation the number of primary and recurrent BCC and analysis of localisation with higher risk of BCC	- Determined For each localisation the number of primary and recurrent BCC and analysis of localisation with higher risk of BCC	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of correlation between localisation and histology characteristics	Analysis of correlation between localisation and histology characteristics	1 day
Analysis of correlation between histological type and recurrence risk	Analysis of correlation between histological type and recurrence risk	1 day
Analysis if there is a difference between first resection histological type and the recurrent histological type	Analysis if there is a difference between first resection histological type and the recurrent histological type	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Sophie Pons, Resident, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 20, 2021

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Resection of BCC (Basal Cell Carcinoma); Recurrence of BCC (Basal Cell Carcinoma); Localisation
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Basal Cell
• Other Study ID Numbers: RECHMPL21_0156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No