- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04795297
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Montpellier, Frankrig, 34295
- UHMontpellier
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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recurrent BCC
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resected BCC
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
- Determined For each localisation the number of primary and recurrent BCC and analysis of localisation with higher risk of BCC
Tidsramme: 1 day
|
- Determined For each localisation the number of primary and recurrent BCC and analysis of localisation with higher risk of BCC
|
1 day
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Analysis of correlation between localisation and histology characteristics
Tidsramme: 1 day
|
Analysis of correlation between localisation and histology characteristics
|
1 day
|
Analysis of correlation between histological type and recurrence risk
Tidsramme: 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
Tidsramme: 1 day
|
Analysis if there is a difference between first resection histological type and the recurrent histological type
|
1 day
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Sophie Pons, Resident, University Hospital, Montpellier
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RECHMPL21_0156
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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