Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое biological sampling
  Biological sampling: blood and semen

Первичные конечные точки

• measurement of biological parameters : Anti-Müllerian hormone (AMH) levels in women [Срок оценки: T1 (=Day0 + 12 months)]
• measurement of biological parameters : Change in sperm motility count in men [Срок оценки: T1 (=Day0 + 12 months)]

Вторичные конечные точки (4)

• measurement of biological parameters : Antral follicle count in women [Срок оценки: T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.]
• measurement of biological parameters : levels of spermatozoids with sperm chromatin abnormalities [Срок оценки: T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.]
• measurement of biological parameters : Change in sperm count [Срок оценки: T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.]
• measurement of biological parameters : Change in sperm motility count [Срок оценки: T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 12 центров

• CHU de Bordeaux — Bordeaux
• AP-HM — Marseille
• Hôpital Saint-Joseph — Marseille
• CHU Montpellier — Montpellier
• CHU de Nantes — Nantes
• CHU NICE L'archet — Nice
• CHRU de Nîmes — Nîmes
• APHP- Ambroise Paré — Paris
• … и ещё 4 центра

Идентификаторы

NCT: NCT05429138 · 2021-A02601-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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