NCT04795297

Brief Summary

.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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
804

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

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

February 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2021

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 10, 2021

Last Update Submit

March 10, 2021

Conditions

Keywords

Resection of BCC (Basal Cell Carcinoma)Recurrence of BCC (Basal Cell Carcinoma)Localisation

Outcome Measures

Primary Outcomes (1)

  • - 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 Outcomes (3)

  • Analysis of correlation between localisation and histology characteristics

    1 day

  • 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

    1 day

Study Arms (2)

recurrent BCC

recurrent BCC

resected BCC

resected BCC

Eligibility Criteria

Age16 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- Patients with resected BCC

You may not qualify if:

  • Biopsies of BCC,
  • revised surgery of incomplete resection.
  • Cases :
  • Recurrent BCC with complete first resection
  • \- Recurrent BCC with incomplete first resection, Patients with Gorlin syndrome (a genetic disease that increase risk of BCC)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Study Officials

  • Sophie Pons, Resident

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 12, 2021

Study Start

February 1, 2020

Primary Completion

February 1, 2021

Study Completion

February 20, 2021

Last Updated

March 12, 2021

Record last verified: 2021-03

Locations