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ClinicalTrials.gov ID

NCT07606508

Lead Sponsor

University Hospital, LilleOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

1,500Estimated

Last Update Posted

May 26, 2026Actual

Start Date

Jul 9, 2021Actual

Primary Completion Date

Jul 15, 2036Estimated

Completion Date

Jul 15, 2036Estimated

Official Title

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

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

• Cutaneous Squamous Cell Carcinoma (CSCC)

• Systemic treatment

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Observational Model

Cohort

Time Perspective

Other

Lead Sponsor

University Hospital, LilleOTHER

Collaborators

SanofiINDUSTRY

Regeneron PharmaceuticalsINDUSTRY

Skin Cancer FoundationUNKNOWN

faubin@chu-besancon.fr33 3 81 66 81 66

laurent.mortier@chu-lille.fr33 3 20 44 41 93

gaelle.quereux@chu-nantes.fr33 2 40 08 33 33

montaudie.h@chu-nice.fr33 4 92 03 60 83

Celeste.lebbe@aphp.fr+33-1-42-49-93-92