Impact of melanoma treatment on fertility parameters
Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma
This study is testing how certain melanoma treatments affect fertility in young men and women who are of childbearing age.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 12 sites (Bordeaux and 11 other locations) |
| Trial ID | NCT05429138 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effects of adjuvant anti-PD-1 immunotherapy and targeted therapies on ovarian reserve and semen quality in melanoma patients of childbearing age. Participants, including women aged 18 to 37 and men aged 18 to 45, will be assessed at three time points: before treatment initiation, immediately after treatment, and one year after treatment cessation. The study will measure anti-Müllerian hormone (AMH) levels and semen parameters to understand how these therapies impact fertility. A standardized questionnaire will also be used to collect data on factors that may influence fertility.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 37 and men aged 18 to 45 who are about to start adjuvant anti-PD-1 immunotherapy or targeted therapy for high-risk melanoma.
Not a fit: Patients with a history of cytotoxic treatment that may affect fertility parameters or those with pre-existing low fertility markers will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the fertility preservation needs of melanoma patients undergoing treatment.
How similar studies have performed: While this study explores a relatively novel area, similar studies have shown the importance of monitoring fertility parameters in cancer patients undergoing treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bordeaux and 11 other locations
- CHU de Bordeaux — Bordeaux, France (Recruiting)
- Ap-Hm — Marseille, France (Recruiting)
- Hôpital Saint-Joseph — Marseille, France (Recruiting)
- CHU Montpellier — Montpellier, France (Recruiting)
- CHU de Nantes — Nantes, France (Recruiting)
- CHU NICE L'archet — Nice, France (Recruiting)
- CHRU de Nîmes — Nîmes, France (Recruiting)
- APHP- Ambroise Paré — Paris, France (Recruiting)
- APHP-Cochin — Paris, France (Recruiting)
- APHP-Saint Louis — Paris, France (Recruiting)
- Oncôpole de Toulouse — Toulouse, France (Recruiting)
- Institut Gustave Roussy — Villejuif, France (Recruiting)
Study contacts
- Principal investigator: Nausicaa Malissen, MD, PhD — Ap-Hm
- Study coordinator: Nausicaa Malissen, MD, PhD
- Email: nausicaa.malissen@ap-hm.fr
- Phone: 0491384215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.