Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma
Recruiting · NCT05429138 · Observational (researchers observe without assigning treatment) · Lead sponsor: Assistance Publique Hopitaux De Marseille
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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.
Who can take part
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.
Where it is running
12 locations listed.
- 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