Follow-up of a French National Cohort of Patients With Cutaneous Squamous Cell Carcinoma Requiring Systemic Treatment.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients from French Centers belonging to the GCC with Cutaneous Squamous Cell Carcinoma Requiring Systemic Treatment from January 2020
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Systemic treatment
DrugAdjuvant Treatment Neoadjuvant Treatment Curative Treatment
Treatment groups
1,500 Participants
are divided into 1 treatment groupGroup A: Patients with Cutaneous Squamous Cell Carcinoma Requiring Systemic Treatment1 intervention
Trial outcomes
Primary outcomes
1
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 definedSecondary outcomes
1
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 defined2
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 defined3
Characterization of baseline patient features
including demographics, risk factors, comorbidities, clinical presentation and histopatological characteristics
Time frame
At the moment of Cutaneous Squamous Cell Carcinoma Diagnosis, until Day 1 of therapy lineSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Lille
Lead sponsor
Sanofi
Collaborator
Regeneron Pharmaceuticals
Collaborator
Skin Cancer Foundation
Collaborator
Source ClinicalTrials.gov