NCT07606508

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
123mo left

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

29 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Jul 2021Jul 2036

Study Start

First participant enrolled

July 9, 2021

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2036

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2036

Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

15 years

First QC Date

May 11, 2026

Last Update Submit

May 18, 2026

Conditions

Keywords

Cutaneous Squamous Cell Carcinoma (CSCC)skinAdjuvant TreatmentNeoadjuvant treatmentCurative treament

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

Drug: Systemic treatment

Interventions

Adjuvant Treatment Neoadjuvant Treatment Curative Treatment

Patients with Cutaneous Squamous Cell Carcinoma Requiring Systemic Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (29)

CHU Dijon Bourgogne

Amiens, France

NOT YET RECRUITING

Centre Hospitalier Régional d'Orléans

Annecy, France

RECRUITING

CHRU Besançon

Besançon, France

RECRUITING

Centre Hospitalier de Blois

Blois, France

RECRUITING

Hôpital Avicenne

Bobigny, France

RECRUITING

Hôpital Saint André,

Bordeaux, France

RECRUITING

Hôpital Ambroise Paré

Boulogne-Billancourt, France

RECRUITING

CHU de Caen

Caen, France

NOT YET RECRUITING

CHRU de Tours

Chambray-lès-Tours, France

RECRUITING

CHU Estaing

Clermont-Ferrand, France

RECRUITING

CHU Henri Mondor

Créteil, France

RECRUITING

CHU Dijon Bourgogne

Dijon, France

RECRUITING

Centre Hospitalier Le Mans

Le Mans, France

RECRUITING

CHU Lille

Lille, France

RECRUITING

CHU Dijon Bourgogne

Lyon, France

RECRUITING

Hôpital de la Timone

Marseille, France

RECRUITING

CHRU Montpellier Hôpital Saint Eloi

Montpellier, France

RECRUITING

Hôpital St Eloi

Montpellier, France

NOT YET RECRUITING

CHU Nantes

Nantes, France

RECRUITING

CHU de Nice

Nice, France

RECRUITING

Centre Hospitalier Régional d'Orléans

Orléans, France

RECRUITING

Hôpital Bichat-Claude-Bernard

Paris, France

RECRUITING

Hôpital Cochin-Port Royal

Paris, France

NOT YET RECRUITING

Hôpital St Louis

Paris, France

RECRUITING

CHU Charles Nicolle

Rouen, France

RECRUITING

Institut de Cancérologie de l'Ouest

Saint-Herblain, France

RECRUITING

HIA Sainte Anne

Toulon, France

ENROLLING BY INVITATION

Centre Hospitalier de Valence

Valence, France

RECRUITING

CHRU de Nancy

Vandœuvre-lès-Nancy, France

RECRUITING

MeSH Terms

Interventions

Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Central Study Contacts

Eve MAUBEC, PU-PH

CONTACT

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

Locations