Cutaneous Squamous Cell Carcinoma (CSCC)
Conditions
Keywords
Cutaneous Squamous Cell Carcinoma (CSCC), skin, Adjuvant Treatment, Neoadjuvant treatment, Curative treament
Brief summary
In the context where advanced cutaneous squamous cell carcinoma (cSCC) is currently a public health issue due to its increasing incidence and where its management is rapidly evolving, it is essential to characterize and monitor changes in therapeutic strategies for patients requiring systemic treatment with adjuvant/neoadjuvant or curative setting. The overall objective of this study is to describe the long-term, real-life management of patients with cSCC requiring systemic therapy, including their clinical characteristics as well as treatment effectiveness and safety. To achieve this aim, the project is based on the establishment of a French national database of patients with cSCC receiving systemic therapy. This is a non-interventional multicenter study involving approximately 30 centers from the French Cutaneous Oncology Group (GCC), including a retrospective phase (from January 2020 for initiation of first-line systemic therapy) followed by a prospective phase. Time perspective is Retrospective and Prospective
Interventions
Adjuvant Treatment Neoadjuvant Treatment Curative Treatment
Sponsors
University Hospital, Lille
Sanofi
Regeneron Pharmaceuticals
Skin Cancer Foundation
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a diagnosis of primary cutaneous squamous cell carcinoma initiating first-line systemic therapy, whether administered with curative, adjuvant, or neoadjuvant intent. * Male or female patients. * Age ≥18 years. * No documented objection to participation in the study.
Exclusion criteria
* Patients who refuse to participate in the study or who object to the collection or processing of their personal data. * Initiation of systemic therapy prior to 2020. * Patients not requiring systemic therapy. * More than one line of systemic therapy at the time of inclusion. * Patients under legal guardianship or curatorship. * Individuals deprived of liberty. * lack of health insurance coverage.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and duration of treatments according to the line therapy and treatment intent (curative, adjuvant, or neoadjuvant), and their evolution over time. | Long term follow-up, Average of 5 years, Duration of the project not defined |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description in real-life of treatment effectiveness according to treatment type, including response rate, time to response, progression-free survival, overall survival, duration of response, and the incidence of severe toxicities. | Long term follow-up, Average of 5 years, duration of the project not defined | — |
| Identification of novel prognostic factors or predictive factors of treatment response and/or toxicity. | Long term follow-up, Average of 5 years, duration of the project not defined | — |
| Characterization of baseline patient features | At the moment of Cutaneous Squamous Cell Carcinoma Diagnosis, until Day 1 of therapy line | including demographics, risk factors, comorbidities, clinical presentation and histopatological characteristics |
Countries
France
Contacts
CONTACTLaurent MORTIER, PU-PH
CONTACTEve MAUBEC, PU-PH
Outcome results
None listed