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Melanoma therapy may impact fertility – new study investigates

NCT ID NCT05429138

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tracks fertility markers in 80 melanoma patients (women aged 18-37, men aged 18-45) before, during, and after adjuvant therapy with anti-PD-1 or targeted treatments. Researchers measure hormone levels in women and sperm quality in men to see how these change over time. The goal is to better understand the effects of modern melanoma treatments on reproductive health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors understand how melanoma treatments impact fertility, guiding future family planning advice for patients.
What could go wrong
This is an observational study, not a treatment trial. It only measures changes and does not test any new therapy or intervention.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients of childbearing age treated with an adjuvant anti-PD-1 immunotherapy or neoadjuvant plus adjuvant or targeted therapies for a melanoma at high risk of recurrence

Ages

18 to 45 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must have provided a signed, dated and written consent prior to any specific procedures, sampling and analyses * Patients with valide Health Inssurance Scheme * Female between 18 and 37 years old and male between 18 and 45 years old * During the 2 months before the introduction of an approved regimen of adjuvant anti-PD-1 immunotherapy or neoadjuvant plus adjuvant or targeted therapy for an high-risk of reccurence melanoma * Adjuvant or neoadjuvant plus adjuvant treatment must be prescribed as part of routine care Exclusion Criteria: * Individuals deprived of liberty or placed under the authority of a tutor * Patients unable to understand, read and/or sign an informed consent * History of cytotoxic treatment before T0 that can alterate the studied parameters * In male, totale motile sperm count per ejaculate inferior to 39 millions at T0 * In women, an age-specific AMH level inferior to the 10th percentile at T0 * Any condition which in the Investigator's opinion would jeopardize compliance with the protocol of the study * Patients that will received an investigational treatment during the study timeframe (an observational research is allowed) * Patients who have changed the type of adjuvant treatment during adjuvant treatment (targeted switch therapy versus targeted immunotherapy and vice versa) or after the neoadjuvant phase due to the pathological response obtained.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HM

    RECRUITING

    Marseille, France

  • APHP- Ambroise Paré

    RECRUITING

    Paris, France

  • APHP-Cochin

    RECRUITING

    Paris, France

  • APHP-Saint Louis

    RECRUITING

    Paris, France

  • CHRU de Nîmes

    RECRUITING

    Nîmes, France

  • CHU Montpellier

    RECRUITING

    Montpellier, France

  • CHU NICE L'archet

    RECRUITING

    Nice, France

  • CHU de Bordeaux

    RECRUITING

    Bordeaux, France

  • CHU de Nantes

    RECRUITING

    Nantes, France

  • Hôpital Saint-Joseph

    RECRUITING

    Marseille, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, France

  • Oncôpole de Toulouse

    RECRUITING

    Toulouse, France

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