Active not recruitingOBSERVATIONAL

Minimal SN Tumor Burden

This study is gathering information to help doctors decide the best treatment for people with a specific type of skin cancer called melanoma. If melanoma cells are found in a lymph node, doctors usually suggest a surgery to remove more lymph nodes. This is called a complete lymph node dissection (CLND). However, if only a very tiny amount of cancer is found in the first lymph node, this surgery might not be needed. This study aims to collect information to see if patients with these very small amounts of cancer can be safely watched without needing the bigger surgery, which can have side effects. We want to find out if skipping the larger surgery is a safe option for these patients.

At a glance

Status

Active not recruiting

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrolment target

296

Start

01 Jul 2009

Estimated completion

01 Dec 2031

Cutaneous Melanoma

What is this study about?

When someone has melanoma, doctors often check the nearby lymph nodes to see if the cancer has spread. If cancer cells are found in a lymph node, it's called a 'positive' lymph node. Traditionally, if any cancer cells are found, doctors suggest a surgery called a complete lymph node dissection (CLND). This involves removing all the lymph nodes in that area.

However, this surgery can have side effects. Also, we know that for many patients, only the first one or two nodes have cancer cells, meaning the bigger surgery might not actually help them. In fact, for people with only a very tiny amount of cancer in their lymph nodes, the bigger surgery doesn't seem to improve their chances of survival, though it can provide more information.

This study, which is a registry, aims to collect information from many patients with a very small amount of melanoma in their lymph nodes. By doing this, we hope to understand whether these patients can safely avoid the larger surgery and still have good outcomes. We want to find a better way to decide who really needs the surgery and who can be safely watched instead, reducing unnecessary procedures and side effects.

Key takeaways

This study focuses on melanoma patients with very tiny amounts of cancer in their lymph nodes.
It aims to see if these patients can avoid a larger surgery (CLND).
The study is collecting information from patients' existing medical records.
No new treatments or procedures are involved in this registry.
The goal is to improve future treatment decisions for these patients.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with a type of skin cancer called primary cutaneous melanoma. The most important part is that if cancer cells were found in your lymph nodes, there must only be a very small amount.

Specifically, the cancer cells in your lymph node must either be in the outer layer (not deeply spread) and be very tiny (less than 0.4 mm across), or if they are anywhere else in the lymph node, they must be extremely small (less than 0.1 mm across). Even if more than one lymph node has a small amount of cancer, you might still be able to join.

There are also some things that would mean you can't join. For example, if you've had another cancer (except for certain common skin cancers or cervical cancer) in the last five years, or if there are other reasons that might make it hard for you to attend follow-up appointments.

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 melanoma (skin cancer)?
If cancer was found in your lymph nodes, was it a very small amount?
Have you had any other cancers in the last 5 years, apart from basic skin cancers or cervical cancer?
Can you attend all your regular follow-up appointments?

Answer every question to see your result.

What does participation involve?

This study is a registry, which means it will mainly involve collecting information about your health and treatment. You won't be given any new medication as part of this study. You will continue to receive the care your doctor recommends for you. The study will track your health information over time, likely through your regular doctor's visits, to see how patients with minimal cancer in their lymph nodes do with different approaches to treatment. The exact duration of your participation will depend on the standard follow-up schedule for your melanoma treatment.

Potential risks and benefits

The main benefit of this study is that the information collected will help doctors understand the best way to treat melanoma patients with very small amounts of cancer in their lymph nodes. This could lead to fewer patients needing a major surgery in the future, which would avoid potential side effects. There are no direct medical risks from participating in this registry, as it involves collecting existing medical information rather than new treatments or procedures. You are free to withdraw from contributing your data to the registry at any time without affecting your medical care.

Locations (22)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

U.Z. Leuven - Campus Gasthuisberg
Verified postcode
Leuven, Belgium
CHRU de Lille
Verified postcode
Lille, France
CHU de Nice - Hopital De L'Archet
Verified postcode
Nice, France
Institut Gustave Roussy
Verified postcode
Paris, France
Charite - Universitaetsmedizin Berlin - Campus Mitte
Verified postcode
Berlin, Germany
Universitaetsklinikum - Essen
Verified postcode
Essen, Germany
UniversitaetsMedizin Mannheim
Verified postcode
Mannheim, Germany
Istituto Europeo di Oncologia
Verified postcode
Milan, Italy
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Verified postcode
Naples, Italy
Istituto Oncologico Veneto IRCCS - Ospedale Busonera
Verified postcode
Padova, Italy
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
Verified postcode
Amsterdam, Netherlands
Erasmus MC Cancer Institute - location Daniel den Hoed
Verified postcode
Rotterdam, Netherlands

Common questions

What is a lymph node dissection?

It's a surgery where doctors remove several lymph nodes from a specific part of your body to check for cancer cells.

What does 'minimal tumour burden' mean?

It means only a very small amount of cancer cells are found in the lymph node, often just tiny specks.

Will I get a new treatment in this study?

No, this study is about collecting information from your regular medical care, not giving new treatments.

What is a registry in a medical study?

A registry is like a secure database where doctors collect information from many patients to learn more about a disease or how treatments work over time.

How long will my information be part of this study?

Your information will be followed for as long as your doctor recommends for your melanoma care, to see long-term outcomes.