Follow-up of a French National Cohort of Patients With Cutaneous Squamous Cell Carcinoma Requiring Systemic Treatment.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Systemic treatment.
- Who it may be relevant to
- Registry conditions: Cutaneous Squamous Cell Carcinoma (CSCC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Systemic treatment
Adjuvant Treatment Neoadjuvant Treatment Curative Treatment
Primary outcome measures
- Frequency and duration of treatments according to the line therapy and treatment intent (curative, adjuvant, or neoadjuvant), and their evolution over time. [Time frame: Long term follow-up, Average of 5 years, Duration of the project not defined]
Secondary outcome measures (3)
- 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. [Time frame: 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. [Time frame: Long term follow-up, Average of 5 years, duration of the project not defined]
- Characterization of baseline patient features [Time frame: At the moment of Cutaneous Squamous Cell Carcinoma Diagnosis, until Day 1 of therapy line]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 29 centers
- CHU Dijon Bourgogne — Amiens
- Centre Hospitalier Régional d'Orléans — Annecy
- CHRU Besançon — Besançon
- Centre Hospitalier de Blois — Blois
- Hôpital Avicenne — Bobigny
- Hôpital Saint André, — Bordeaux
- Hôpital Ambroise Paré — Boulogne-Billancourt
- CHU de Caen — Caen
- … and 21 more centers
Identifiers
NCT: NCT07606508 · 2020_81 · IDRCB