Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma

Study Purpose

Prospective multicentric study including women aged 18 to 37 and men aged 18 to 45 during their visit to centers for the study and storage of human sperm and eggs (CECOS). Subjects will be included before adjuvant treatment initiation (T0) and immediately after treatment (approximately 1 year after initiation, T1), and, in late post treatment (1 year after treatment cessation, T2). Expected results: This study will evaluate the evolution of AMH, AFC, and semen parameters in our cohort of melanoma patients treated with anti-PD-1 and targeted therapy in an adjuvant and neoadjuvantsettings.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 45 Years
Gender	All

More 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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05429138
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Assistance Publique Hopitaux De Marseille
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Nausicaa Malissen, MD, PhD
Principal Investigator Affiliation	AP-HM
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma

Additional Details

To the best of our knowledge, no data is available in humans on the impact of anti-PD-1 immunotherapies and therapies targeting the MAP kinase pathway, in adjuvant settings, on ovarian reserve and semen quality. Main objective: to measure pre-treatment (T0) and immediate post-treatment (T1) evolution of anti-Müllerian hormone (AMH) levels reflecting the ovarian reserve in women, and of the total motile sperm count per ejaculate in men, in patients of childbearing age treated with anti-PD-1 immunotherapy or targeted therapies in an adjuvant situation for melanoma at high risk of recurrence. Method: Prospective multicentric study including women aged 18 to 37 and men aged 18 to 45 during their visit to centers for the study and storage of human sperm and eggs (CECOS). Subjects will be included before adjuvant treatment initiation (T0) and immediately after treatment (approximately 1 year after initiation, T1), and, in late post treatment (1 year after treatment cessation, T2). At each of their visit to CECOS (T0, T1 and T2), the women will have an AMH assay and an antral follicle count (AFC) by ultrasound while the men will perform a semen analysis (count, spermocytogram and staining with aniline blue for analysis of chromatin condensation). A standardized questionnaire aimed at collecting data about factors that may alter fertility will be submitted at each of these visits. Expected results: This study will evaluate the evolution of AMH, AFC, and semen parameters in our cohort of melanoma patients treated with anti-PD-1 and targeted therapy in an adjuvant settings.

Arms & Interventions

Arms

: Immunotherapy cohort

Patient that received adjuvant immunotherapy

: Targeted therapy

Patient that received adjuvant targeted therapy

Interventions

Other: - biological sampling

Biological sampling: blood and semen

Contact a Trial Team

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