Follow-up of a French National Cohort of Patients With Cutaneous Squamous Cell Carcinoma Requiring Systemic Treatment. (CAREPI)

May 18, 2026 updated by: University Hospital, Lille

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France
        • Not yet recruiting
        • Chu Dijon Bourgogne
        • Principal Investigator:
          • Jean-Philippe ARNAULT
        • Contact:
      • Annecy, France
        • Recruiting
        • Centre Hospitalier Régional d'Orléans
        • Contact:
        • Principal Investigator:
          • Jule DE QUATREBARBES
      • Besançon, France
        • Recruiting
        • CHRU Besançon
        • Contact:
        • Principal Investigator:
          • François AUBIN
      • Blois, France
        • Recruiting
        • Centre Hospitalier de Blois
        • Principal Investigator:
          • Guido Bens
        • Contact:
      • Bobigny, France
        • Recruiting
        • Hopital Avicenne
        • Principal Investigator:
          • Eve Maubec
        • Contact:
      • Bordeaux, France
        • Recruiting
        • Hôpital Saint André,
        • Principal Investigator:
          • Marie BEYLOT-BARRY
        • Contact:
      • Boulogne-Billancourt, France
        • Recruiting
        • Hopital Ambroise Pare
        • Contact:
        • Principal Investigator:
          • Elisa FUNCK-BRENTANO
      • Caen, France
        • Not yet recruiting
        • CHU de Caen
        • Contact:
        • Principal Investigator:
          • Anne DOMPMARTIN
      • Chambray-lès-Tours, France
        • Recruiting
        • CHRU de Tours
        • Contact:
        • Principal Investigator:
          • Mahtab SAMIMI
      • Clermont-Ferrand, France
        • Recruiting
        • CHU Estaing
        • Contact:
        • Principal Investigator:
          • Sandrine MANSARD
      • Créteil, France
        • Recruiting
        • Chu Henri Mondor
        • Contact:
        • Principal Investigator:
          • Ouidad ZEHOU
      • Dijon, France
        • Recruiting
        • Chu Dijon Bourgogne
        • Principal Investigator:
          • Géraldine Jeudy
        • Contact:
      • Le Mans, France
        • Recruiting
        • Centre Hospitalier Le Mans
        • Principal Investigator:
          • Nathalie BENETON
        • Contact:
      • Lille, France
        • Recruiting
        • Chu Lille
        • Principal Investigator:
          • Laurent MORTIER
        • Contact:
      • Lyon, France
        • Recruiting
        • Chu Dijon Bourgogne
        • Contact:
        • Principal Investigator:
          • Mona AMINI ADLE
      • Marseille, France
        • Recruiting
        • Hôpital de la Timone
        • Contact:
        • Principal Investigator:
          • Caroline GAUDY - MARQUESTE
      • Montpellier, France
        • Not yet recruiting
        • Hôpital St Eloi
        • Principal Investigator:
          • Olivier DEREURE
        • Contact:
      • Montpellier, France
        • Recruiting
        • CHRU Montpellier Hôpital Saint Eloi
        • Contact:
        • Principal Investigator:
          • Candice Lasage
      • Nantes, France
        • Recruiting
        • Chu Nantes
        • Principal Investigator:
          • Gaëlle QUEREUX
        • Contact:
      • Nice, France
        • Recruiting
        • CHU de Nice
        • Principal Investigator:
          • Henri Montaudié
        • Contact:
      • Orléans, France
        • Recruiting
        • Centre Hospitalier Régional d'Orléans
        • Contact:
        • Principal Investigator:
          • Antoine MARCHAND
      • Paris, France
        • Recruiting
        • Hôpital St Louis
        • Principal Investigator:
          • Céleste Lebbe
        • Contact:
      • Paris, France
        • Recruiting
        • Hôpital Bichat-Claude-Bernard
        • Principal Investigator:
          • Florence Brunet-Possenti
        • Contact:
      • Paris, France
        • Not yet recruiting
        • Hôpital Cochin-Port Royal
        • Contact:
        • Principal Investigator:
          • Sarah GUEGAN
      • Rouen, France
        • Recruiting
        • CHU Charles Nicolle
        • Principal Investigator:
          • Anne-Bénedicte Duval-Modeste
        • Contact:
      • Saint-Herblain, France
        • Recruiting
        • Institut de Cancérologie de l'Ouest
        • Contact:
        • Principal Investigator:
          • Lucie PEUVREL
      • Toulon, France
        • Enrolling by invitation
        • HIA Sainte Anne
      • Valence, France
        • Recruiting
        • Centre Hospitalier de Valence
        • Contact:
        • Principal Investigator:
          • Florent GRANGE
      • Vandœuvre-lès-Nancy, France
        • Recruiting
        • CHRU de Nancy
        • Contact:
        • Principal Investigator:
          • Florence GRANEL-BROCARD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients from French Centers belonging to the GCC with Cutaneous Squamous Cell Carcinoma Requiring Systemic Treatment from January 2020

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Cutaneous Squamous Cell Carcinoma Requiring Systemic Treatment
Drug: Systemic treatment
Adjuvant Treatment Neoadjuvant Treatment Curative Treatment

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: Long term follow-up, Average of 5 years, Duration of the project not defined
Long term follow-up, Average of 5 years, Duration of the project not defined

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
including demographics, risk factors, comorbidities, clinical presentation and histopatological characteristics
At the moment of Cutaneous Squamous Cell Carcinoma Diagnosis, until Day 1 of therapy line

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Sanofi
Regeneron Pharmaceuticals
Skin Cancer Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2021

Primary Completion (Estimated)

July 15, 2036

Study Completion (Estimated)

July 15, 2036

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 18, 2026

First Posted (Actual)

May 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020_81
  • IDRCB (Other Identifier: 2025-A01568-41)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cutaneous Squamous Cell Carcinoma (CSCC)

Clinical Trials on Systemic treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe