Cutaneous Squamous Cell Carcinoma (CSCC)CAREPINCT07606508
Follow-up of a French National Cohort of Patients With Cutaneous Squamous Cell Carcinoma Requiring Systemic Treatment.
An observational study of Cutaneous Squamous Cell Carcinoma (CSCC), run by University Hospital, Lille at 29 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma (CSCC)
- What is being tested?
- Systemic treatment
- How many people
- 1,500 participants
- Where
- 29 sitesFrance
- Study dates
- 9 Jul 2021to 15 Jul 2036
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from French Centers belonging to the GCC with Cutaneous Squamous Cell Carcinoma Requiring Systemic Treatment from January 2020
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
29 sites in 1 country. Contact the study team or a site near you to ask about taking part.
29 sites in 1 country
France29 sites, 29 recruiting
- Not yet recruiting
CHU Dijon Bourgogne
Amiens
Jean-Philippe ARNAULT, 33 3 22 45 58 43, arnault.jean-philippe@chu-amiens.fr
Jean-Philippe ARNAULT
- Recruiting
Centre Hospitalier Régional d'Orléans
Annecy
Julie DE QUATREBARBES, 33 4 50 63 68 63, jdequatrebarbes@ch-annecygenevois.fr
Jule DE QUATREBARBES
- Recruiting
CHRU Besançon
Besançon
François AUBIN, 33 3 81 66 81 66, faubin@chu-besancon.fr
François AUBIN
- Recruiting
Centre Hospitalier de Blois
Blois
Guido BENS, 33 2 54 55 66 33, bensgui@ch-blois.fr
Guido Bens
- Recruiting
Hôpital Avicenne
Bobigny
Eve MAUBEC, 33 1 48 95 70 96, eve.maubec@aphp.fr
Eve Maubec
- Recruiting
Hôpital Saint André,
Bordeaux
Marie BEYLOT-BARRY, 33 5 57 82 25 00, marie.beylot-barry@chu-bordeaux.fr
Marie BEYLOT-BARRY
- Recruiting
Hôpital Ambroise Paré
Boulogne-Billancourt
Elisa FUNCK BRENTANO, 33 1 49 09 56 73, elisa.funck-brentano@aphp.fr
Elisa FUNCK-BRENTANO
- Not yet recruiting
CHU de Caen
Caen
Anne DOMPMARTIN, 33 2 31 27 20 10, dompmartin-a@chu-caen.fr
Anne DOMPMARTIN
- Recruiting
CHRU de Tours
Chambray-lès-Tours
Mahtab SAMIMI, 33 247474747, mahtab.samimi@univ-tours.fr
Mahtab SAMIMI
- Recruiting
CHU Estaing
Clermont-Ferrand
Sandrine MANSARD, 33 4 73 75 05 50, smansard@chu-clermont-ferrand.fr
Sandrine MANSARD
- Recruiting
CHU Henri Mondor
Créteil
Ouidad ZEHOU, 33 3 149814513, ouidad.zehou@aphp.fr
Ouidad ZEHOU
- Recruiting
CHU Dijon Bourgogne
Dijon
Géraldine JEUDY, 33 3 80 29 33 36, geraldine.jeudy@chu-dijon.fr
Géraldine Jeudy
- Recruiting
Centre Hospitalier Le Mans
Le Mans
Nathalie BENETON, +33 2 43 43 43 43, nbeneton@ch-lemans.fr
Nathalie BENETON
- Recruiting
CHU Lille
Lille
Laurent MORTIER, 33 3 20 44 41 93, laurent.mortier@chu-lille.fr
Laurent MORTIER
- Recruiting
CHU Dijon Bourgogne
Lyon
Mona AMINI-ADLE, 33 4 78 78 59 66, mona.amini-adle@lyon.unicancer.fr
Mona AMINI ADLE
- Recruiting
Hôpital de la Timone
Marseille
Caroline GAUDY - MARQUESTE, 33 4 91 38 57 80, Caroline.Gaudy@mail.ap-hm.fr
Caroline GAUDY - MARQUESTE
- Recruiting
CHRU Montpellier Hôpital Saint Eloi
Montpellier
Candice Lesage, 33 4 67 33 69 06, candice-lesage@chu-montpellier.fr
Candice Lasage
- Not yet recruiting
Hôpital St Eloi
Montpellier
Olivier DEREURE, 33 4 67 33 69 06, o-dereure@chu-montpellier.fr
Olivier DEREURE
- Recruiting
CHU Nantes
Nantes
Gaëlle QUEREUX, 33 2 40 08 33 33, gaelle.quereux@chu-nantes.fr
Gaëlle QUEREUX
- Recruiting
CHU de Nice
Nice
Henri Montaudié, 33 4 92 03 60 83, montaudie.h@chu-nice.fr
Henri Montaudié
- Recruiting
Centre Hospitalier Régional d'Orléans
Orléans
Antoine MARCHAND, 33 2 38 51 44 44, antoine.marchand@chu-orleans.fr
Antoine MARCHAND
- Recruiting
Hôpital Bichat-Claude-Bernard
Paris
Florence BRUNET-POSSENTI, 33 1 40 25 80 80, florence.brunet-possenti@aphp.fr
Florence Brunet-Possenti
- Not yet recruiting
Hôpital Cochin-Port Royal
Paris
Sarah GUEGAN, 33 1 58 41 18 06, sarah.guegan@aphp.fr
Sarah GUEGAN
- Recruiting
Hôpital St Louis
Paris
Céleste Lebbe, +33-1-42-49-93-92, Celeste.lebbe@aphp.fr
Céleste Lebbe
- Recruiting
CHU Charles Nicolle
Rouen
Anne-Bénédicte DUVAL-MODESTE, 33 2 32 88 81 41, anne-benedicte.duval-modeste@chu-rouen.fr
Anne-Bénedicte Duval-Modeste
- Recruiting
Institut de Cancérologie de l'Ouest
Saint-Herblain
Lucie PEUVREL, 33 2 40 67 98 93, lucie.peuvrel@ico.unicancer.fr
Lucie PEUVREL
- Enrolling by invitation
HIA Sainte Anne
Toulon
- Recruiting
Centre Hospitalier de Valence
Valence
Florent GRANGE, 33 4 75 75 75 49, fgrange@ch-valence.fr
Florent GRANGE
- Recruiting
CHRU de Nancy
Vandœuvre-lès-Nancy
Florence GRANEL-BROCARD, 33 3 83 15 71 46, f.granel-brocard@chu-nancy.fr
Florence GRANEL-BROCARD
About this study
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
- Conditions
- Cutaneous Squamous Cell Carcinoma (CSCC)
- Being tested
- Systemic treatment
- Keywords
- Cutaneous Squamous Cell Carcinoma (CSCC), skin, Adjuvant Treatment, Neoadjuvant treatment, Curative treament
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic treatmentDrug
Adjuvant Treatment Neoadjuvant Treatment Curative Treatment
| Study group | Role | What they receive |
|---|---|---|
| Patients with Cutaneous Squamous Cell Carcinoma Requiring Systemic Treatment | Not described Receives: Drug: Systemic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and duration of treatments according to the line therapy and treatment intent (curative, adjuvant, or neoadjuvant), and their evolution over time.
Measured: 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.
Measured: 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.
Measured: 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
Measured: At the moment of Cutaneous Squamous Cell Carcinoma Diagnosis, until Day 1 of therapy line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start9 Jul 2021
- Primary completion15 Jul 2036 (estimated)
- Study completion15 Jul 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Squamous Cell Carcinoma (CSCC)Studies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Regeneron Pharmaceuticals, Skin Cancer Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606508
- Sponsor's protocol ID
- 2020_81
- Other IDs
- IDRCB
- Acronym
- CAREPI
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of a French National Cohort of Patients With Cutaneous Squamous Cell Carcinoma Requiring Systemic Treatment.
- ClinicalTrials.gov ID
- NCT07606508
- Acronym / sponsor ID
- CAREPI / 2020_81
- Conditions
- Cutaneous Squamous Cell Carcinoma (CSCC)
- Keywords
- Cutaneous Squamous Cell Carcinoma (CSCC), skin, Adjuvant Treatment, Neoadjuvant treatment, Curative treament
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Sanofi, Regeneron Pharmaceuticals, Skin Cancer Foundation
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 15 Jul 2036 (estimated)
- Study completion
- 15 Jul 2036 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Cutaneous Squamous Cell Carcinoma Requiring Systemic Treatment | – | Drug: Systemic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from French Centers belonging to the GCC with Cutaneous Squamous Cell Carcinoma Requiring Systemic Treatment from January 2020
Key inclusion criteria (4 listed)
- Patients with a diagnosis of primary cutaneous squamous cell carcinoma initiating first-line systemic therapy, whether administered with curative, adjuvant, or neoadjuvant intent.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic treatmentAdjuvant Treatment Neoadjuvant Treatment Curative Treatment | Drug | Patients with Cutaneous Squamous Cell Carcinoma Requiring Systemic Treatment |
Primary outcome
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
3 secondary outcomes
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
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
Characterization of baseline patient features
Time frame: At the moment of Cutaneous Squamous Cell Carcinoma Diagnosis, until Day 1 of therapy line
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Squamous Cell Carcinoma (CSCC), run by University Hospital, Lille at 29 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent MORTIER, PU-PH (33 3 20 44 41 93, laurent.mortier@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.