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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB | Other Identifier | 2021-A00960-41 |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
| Regeneron Pharmaceuticals | INDUSTRY |
| Skin Cancer Foundation | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Cutaneous Squamous Cell Carcinoma Requiring Systemic Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systemic treatment | Drug | Adjuvant Treatment Neoadjuvant Treatment Curative Treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. | 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. |
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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.
Exclusion Criteria:
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Patients from French Centers belonging to the GCC with Cutaneous Squamous Cell Carcinoma Requiring Systemic Treatment from January 2020
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurent MORTIER, PU-PH | Contact | 33 3 20 44 41 93 | laurent.mortier@chu-lille.fr | |
| Eve MAUBEC, PU-PH | Contact | 33 1 48 95 70 96 | eve.maubec@aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Dijon Bourgogne | Not yet recruiting | Amiens | France |
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| Long term follow-up, Average of 5 years, duration of the project not defined |
| Characterization of baseline patient features | 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 |
| Centre Hospitalier Régional d'Orléans | Recruiting | Annecy | France |
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| CHRU Besançon | Recruiting | Besançon | France |
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| Centre Hospitalier de Blois | Recruiting | Blois | France |
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| Hôpital Avicenne | Recruiting | Bobigny | France |
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| Hôpital Saint André, | Recruiting | Bordeaux | France |
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| Hôpital Ambroise Paré | Recruiting | Boulogne-Billancourt | France |
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| CHU de Caen | Not yet recruiting | Caen | France |
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| CHRU de Tours | Recruiting | Chambray-lès-Tours | France |
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| CHU Estaing | Recruiting | Clermont-Ferrand | France |
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| CHU Henri Mondor | Recruiting | Créteil | France |
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| CHU Dijon Bourgogne | Recruiting | Dijon | France |
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| Centre Hospitalier Le Mans | Recruiting | Le Mans | France |
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| CHU Lille | Recruiting | Lille | France |
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| CHU Dijon Bourgogne | Recruiting | Lyon | France |
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| Hôpital de la Timone | Recruiting | Marseille | France |
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| CHRU Montpellier Hôpital Saint Eloi | Recruiting | Montpellier | France |
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| Hôpital St Eloi | Not yet recruiting | Montpellier | France |
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| CHU Nantes | Recruiting | Nantes | France |
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| CHU de Nice | Recruiting | Nice | France |
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| Centre Hospitalier Régional d'Orléans | Recruiting | Orléans | France |
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| Hôpital Bichat-Claude-Bernard | Recruiting | Paris | France |
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| Hôpital Cochin-Port Royal | Not yet recruiting | Paris | France |
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| Hôpital St Louis | Recruiting | Paris | France |
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| CHU Charles Nicolle | Recruiting | Rouen | France |
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| Institut de Cancérologie de l'Ouest | Recruiting | Saint-Herblain | France |
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| HIA Sainte Anne | Enrolling by invitation | Toulon | France |
| Centre Hospitalier de Valence | Recruiting | Valence | France |
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| CHRU de Nancy | Recruiting | Vandœuvre-lès-Nancy | France |
|
| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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