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NCT Number: NCT07606508

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

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

Recruiting

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Key information

Conditions

Cutaneous Squamous Cell Carcinoma (CSCC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Dijon Bourgogne, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Systemic treatment

Drug

Adjuvant Treatment Neoadjuvant Treatment Curative Treatment

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 defined

Secondary 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 defined

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Eve MAUBEC, PU-PH

CONTACT

[email protected]

33 1 48 95 70 96

Laurent MORTIER, PU-PH

CONTACT

[email protected]

33 3 20 44 41 93

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Regeneron Pharmaceuticals
  • Sanofi
  • Skin Cancer Foundation

Registry information

Acronym: CAREPI

Important dates

Study start
2021
Primary completion
2036
Study completion
2036
First posted
May 26, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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