Follow-up of a French National Cohort of Patients With Cutaneous Squamous Cell Carcinoma Requiring Systemic Treatment.
CAREPI
2 other identifiers
observational
1,500
1 country
29
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
Longer than P75 for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 9, 2021
CompletedFirst Submitted
Initial submission to the registry
May 11, 2026
CompletedFirst Posted
Study publicly available on registry
May 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2036
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 15, 2036
May 26, 2026
May 1, 2026
15 years
May 11, 2026
May 18, 2026
Conditions
Keywords
Outcome Measures
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.
Long term follow-up, Average of 5 years, Duration of the project not defined
Secondary Outcomes (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.
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
Study Arms (1)
Patients with Cutaneous Squamous Cell Carcinoma Requiring Systemic Treatment
Interventions
Adjuvant Treatment Neoadjuvant Treatment Curative Treatment
Eligibility Criteria
Patients from French Centers belonging to the GCC with Cutaneous Squamous Cell Carcinoma Requiring Systemic Treatment from January 2020
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Patients under legal guardianship or curatorship.
- Individuals deprived of liberty.
- lack of health insurance coverage.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Lillelead
- Sanoficollaborator
- Regeneron Pharmaceuticalscollaborator
- Skin Cancer Foundationcollaborator
Study Sites (29)
CHU Dijon Bourgogne
Amiens, France
Centre Hospitalier Régional d'Orléans
Annecy, France
CHRU Besançon
Besançon, France
Centre Hospitalier de Blois
Blois, France
Hôpital Avicenne
Bobigny, France
Hôpital Saint André,
Bordeaux, France
Hôpital Ambroise Paré
Boulogne-Billancourt, France
CHU de Caen
Caen, France
CHRU de Tours
Chambray-lès-Tours, France
CHU Estaing
Clermont-Ferrand, France
CHU Henri Mondor
Créteil, France
CHU Dijon Bourgogne
Dijon, France
Centre Hospitalier Le Mans
Le Mans, France
CHU Lille
Lille, France
CHU Dijon Bourgogne
Lyon, France
Hôpital de la Timone
Marseille, France
CHRU Montpellier Hôpital Saint Eloi
Montpellier, France
Hôpital St Eloi
Montpellier, France
CHU Nantes
Nantes, France
CHU de Nice
Nice, France
Centre Hospitalier Régional d'Orléans
Orléans, France
Hôpital Bichat-Claude-Bernard
Paris, France
Hôpital Cochin-Port Royal
Paris, France
Hôpital St Louis
Paris, France
CHU Charles Nicolle
Rouen, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, France
HIA Sainte Anne
Toulon, France
Centre Hospitalier de Valence
Valence, France
CHRU de Nancy
Vandœuvre-lès-Nancy, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2026
First Posted
May 26, 2026
Study Start
July 9, 2021
Primary Completion (Estimated)
July 15, 2036
Study Completion (Estimated)
July 15, 2036
Last Updated
May 26, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share