Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma (MELpreserv)

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Enrolling

Conditions

Melanoma

Treatments

Other: biological sampling

Study type

Observational

Funder types

Other

Identifiers

NCT05429138

2021-A02601-40

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.