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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunotherapy cohort | Patient that received adjuvant immunotherapy |
| |
| Targeted therapy | Patient that received adjuvant targeted therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biological sampling | Other | Biological sampling: blood and semen |
|
| Measure | Description | Time Frame |
|---|---|---|
| measurement of biological parameters : Anti-Müllerian hormone (AMH) levels in women | change in Anti-Müllerian hormone (AMH) levels in women | T1 (=Day0 + 12 months) |
| measurement of biological parameters : Change in sperm motility count in men | Change in sperm motility count per ejaculate in men | T1 (=Day0 + 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| measurement of biological parameters : Antral follicle count in women | change in antral follicle count in women | T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months. |
| measurement of biological parameters : levels of spermatozoids with sperm chromatin abnormalities |
| Measure | Description | Time Frame |
|---|---|---|
| measurement of biological parameters : change in sperm morphology | change in sperm morphology (using spermogram) | T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months. |
Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nausicaa Malissen, MD, PhD | Contact | 0491384215 | nausicaa.malissen@ap-hm.fr | |
| DRSMR AP-HM | Contact | promotion.interne@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nausicaa Malissen, MD, PhD | AP-HM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Recruiting | Bordeaux | France |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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Blood and semen
change of rate of spermatozoids with sperm chromatin abnormalities |
| T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months. |
| measurement of biological parameters : Change in sperm count | Change in sperm count (spermogram) during time | T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months. |
| measurement of biological parameters : Change in sperm motility count | Change in sperm motility count (spermogram) | T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months. |
| AP-HM | Recruiting | Marseille | France |
|
| Hôpital Saint-Joseph | Recruiting | Marseille | France |
|
| CHU Montpellier | Recruiting | Montpellier | France |
|
| CHU de Nantes | Recruiting | Nantes | France |
|
| CHU NICE L'archet | Recruiting | Nice | France |
|
| CHRU de Nîmes | Recruiting | Nîmes | France |
|
| APHP- Ambroise Paré | Recruiting | Paris | France |
|
| APHP-Cochin | Recruiting | Paris | France |
|
| APHP-Saint Louis | Recruiting | Paris | France |
|
| Oncôpole de Toulouse | Recruiting | Toulouse | France |
|
| Institut Gustave Roussy | Recruiting | Villejuif | France |
|
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |