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Brief Title: Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma
Official Title: Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma
Study ID: NCT05429138
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
CHU de Bordeaux, Bordeaux, , France
AP-HM, Marseille, , France
Hôpital Saint-Joseph, Marseille, , France
CHU Montpellier, Montpellier, , France
CHU de Nantes, Nantes, , France
CHU NICE L'archet, Nice, , France
CHRU de Nîmes, Nîmes, , France
APHP- Ambroise Paré, Paris, , France
APHP-Cochin, Paris, , France
APHP-Saint Louis, Paris, , France
Oncôpole de Toulouse, Toulouse, , France
Institut Gustave Roussy, Villejuif, , France
Name: Nausicaa Malissen, MD, PhD
Affiliation: AP-HM
Role: PRINCIPAL_INVESTIGATOR