Clinical trial NCT05429138: 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 type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma
Keywords: melanoma
ovarian reserv
semen parameters
fertility
adjuvant
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of childbearing age treated with an adjuvant anti-PD-1 immunotherapy or neoadjuvant plus adjuvant or targeted therapies for a melanoma at high risk of recurrence

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.

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.

Primary outcomes:
measure: measurement of biological parameters : Anti-Müllerian hormone (AMH) levels in women
timeFrame: T1 (=Day0 + 12 months)
measure: measurement of biological parameters : Change in sperm motility count in men
timeFrame: T1 (=Day0 + 12 months)
Secondary outcomes:
measure: measurement of biological parameters : Antral follicle count in women
timeFrame: T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.
measure: measurement of biological parameters : levels of spermatozoids with sperm chromatin abnormalities
timeFrame: T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.
measure: measurement of biological parameters : Change in sperm count
timeFrame: T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.
measure: measurement of biological parameters : Change in sperm motility count
timeFrame: T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.
Other outcomes:
measure: measurement of biological parameters : change in sperm morphology
timeFrame: T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Marseille
country: France
facility: AP-HM
city: Marseille
country: France
facility: Hôpital Saint-Joseph
city: Montpellier
country: France
facility: CHU Montpellier
city: Nantes
country: France
facility: CHU de Nantes
city: Nice
country: France
facility: CHU NICE L'archet
city: Nîmes
country: France
facility: CHRU de Nîmes
city: Paris
country: France
facility: APHP- Ambroise Paré
city: Paris
country: France
facility: APHP-Cochin
city: Paris
country: France
facility: APHP-Saint Louis
city: Toulouse
country: France
facility: Oncôpole de Toulouse
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: AP-HM
name: Nausicaa Malissen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: