Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma
NCT ID: NCT05429138
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
80 participants
OBSERVATIONAL
2022-12-07
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Immunotherapy cohort
Patient that received adjuvant immunotherapy
biological sampling
Biological sampling: blood and semen
Targeted therapy
Patient that received adjuvant targeted therapy
biological sampling
Biological sampling: blood and semen
Interventions
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biological sampling
Biological sampling: blood and semen
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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Nausicaa Malissen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
AP-HM
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Nausicaa MALISSEN
Role: primary
Vanessa Loup
Role: primary
Henri MONTAUDIE
Role: primary
Other Identifiers
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2021-A02601-40
Identifier Type: -
Identifier Source: org_study_id
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