RecruitingOBSERVATIONAL

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

This study is gathering information about how a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) is treated in France. Specifically, it's looking at patients who need 'systemic treatment' – medicines that affect the whole body, rather than just creams or surgery. Doctors want to understand the different ways this cancer is being managed and how these treatments change over time. They'll be collecting details on patients' health, the treatments they're given, and how effective these treatments are, along with any side effects. The aim is to create a clearer picture of real-life care for CSCC in France, helping to improve future treatments. This research helps us learn more about this cancer as it's becoming more common.

At a glance

Status

Recruiting

Sponsor

University Hospital, Lille

Enrolment target

1,500

Start

09 Jul 2021

Estimated completion

15 Jul 2036

Cutaneous Squamous Cell Carcinoma (CSCC)

What is this study about?

This study is about a type of skin cancer called cutaneous squamous cell carcinoma, or CSCC. This kind of cancer is becoming more common, and the ways doctors treat it are always improving. This means it's really important to understand how patients are currently being treated, especially those who need stronger medicines that work throughout their entire body (which doctors call 'systemic treatment'). These treatments might be given to try and cure the cancer, or to help prevent it from coming back after surgery.

The main goal of this study is to get a clear, long-term picture of how patients with CSCC in France are being cared for when they need these systemic treatments. Researchers want to collect information about the patients themselves – like their age and general health – as well as the specific treatments they receive. They will also look at how well these treatments work in real-life situations and what side effects patients might experience. By gathering all this information, doctors hope to learn what works best and identify any areas where care could be improved.

To do this, the study is setting up a special database across about 30 hospitals in France. It will look back at records from patients who started treatment in 2020 or later, and then continue to follow new patients going forward. This helps build a comprehensive view of how CSCC is managed, giving valuable insights for the future.

Key takeaways

The study focuses on a common skin cancer, CSCC.
It aims to understand real-life management of CSCC with whole-body treatments.
Information from your standard care will help improve future treatments.
No new treatments or extra appointments are involved.
Your privacy will be protected.

Who may be eligible?

To be part of this study, you would need to be an adult (18 years or older) and have received a diagnosis of primary cutaneous squamous cell carcinoma (CSCC). You must be starting your first course of systemic treatment for this cancer. Systemic treatment refers to medicines that work throughout your body, rather than just on one spot, and might be given to cure the cancer, help before or after surgery.

There are some reasons why you couldn't join. For example, if you began your systemic treatment before 2020, or if you've already had more than one type of systemic treatment for your CSCC. Also, if you don't need systemic treatment at all, or if you don't agree to have your information used for the study, you wouldn't be able to participate. The study also cannot include individuals who are under legal guardianship, are in prison, or who do not have health insurance coverage.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with primary cutaneous squamous cell carcinoma (CSCC)?
Are you starting your first systemic (whole-body) treatment for CSCC?
Did you start this treatment in January 2020 or later?
Do you consent to your medical information being used for this study?

Answer every question to see your result.

What does participation involve?

This is not a study where you would receive new or experimental treatments. Instead, doctors will be collecting information from your routine medical care. This means you will continue to have your usual doctor appointments, treatments, and follow-up care as you normally would for your condition. The study will simply gather details about your journey, including your diagnosis, the systemic treatments you receive, how you respond to them, and any side effects. You won't have extra visits or procedures specifically for this study. Your participation mainly involves allowing your medical records to be included in the French national database, with your personal details kept private. The information collected will cover your treatment from January 2020 onwards, if you started around that time, and will continue to track your care for the longer term.

Potential risks and benefits

Because this study is observing the treatments you already receive as part of your standard care, there are no specific extra medical risks associated with participating. The main benefit is that the information gathered from your treatment journey, alongside many others, will help shape a better understanding of cutaneous squamous cell carcinoma (CSCC) and its treatments. This could lead to improved care for future patients. Your personal information will be protected. You have the right to withdraw your consent for your data to be used at any time without affecting your medical care.

Locations (29)

CHU Dijon Bourgogne
Verified postcode
Amiens, France· Not yet recruiting
Centre Hospitalier Régional d'Orléans
Verified postcode
Annecy, France· Recruiting
CHRU Besançon
Verified postcode
Besançon, France· Recruiting
Centre Hospitalier de Blois
Verified postcode
Blois, France· Recruiting
Hôpital Avicenne
Verified postcode
Bobigny, France· Recruiting
Hôpital Saint André,
Verified postcode
Bordeaux, France· Recruiting
Hôpital Ambroise Paré
Verified postcode
Boulogne-Billancourt, France· Recruiting
CHU de Caen
Verified postcode
Caen, France· Not yet recruiting
CHRU de Tours
Verified postcode
Chambray-lès-Tours, France· Recruiting
CHU Estaing
Verified postcode
Clermont-Ferrand, France· Recruiting
CHU Henri Mondor
Verified postcode
Créteil, France· Recruiting
CHU Dijon Bourgogne
Verified postcode
Dijon, France· Recruiting

Common questions

What kind of cancer is this study about?

This study is about a type of skin cancer called cutaneous squamous cell carcinoma, or CSCC.

What does 'systemic treatment' mean?

Systemic treatment means medicines that work throughout your whole body, rather than just on a small, specific area.

Will I get new medicine if I join this study?

No, this study is about observing the treatments you already receive as part of your normal care, not giving new medicines.

Where is this study taking place?

This study is taking place in about 30 hospitals across France.

How will my personal information be protected?

Your personal health information will be collected and kept private within a secure national database, and researchers will make sure your identity is protected.

How to find out more

Laurent MORTIER, PU-PH

laurent.mortier@chu-lille.fr 33 3 20 44 41 93 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.