Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: biological sampling.
- Who it may be relevant to
- Registry conditions: Melanoma. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other biological sampling
Biological sampling: blood and semen
Primary outcome measures
- measurement of biological parameters : Anti-Müllerian hormone (AMH) levels in women [Time frame: T1 (=Day0 + 12 months)]
- measurement of biological parameters : Change in sperm motility count in men [Time frame: T1 (=Day0 + 12 months)]
Secondary outcome measures (4)
- measurement of biological parameters : Antral follicle count in women [Time frame: T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.]
- measurement of biological parameters : levels of spermatozoids with sperm chromatin abnormalities [Time frame: T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.]
- measurement of biological parameters : Change in sperm count [Time frame: T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.]
- measurement of biological parameters : Change in sperm motility count [Time frame: T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
France · 12 centers
- 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
- … and 4 more centers
Identifiers
NCT: NCT05429138 · 2021-A02601-40