Status:
RECRUITING
Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Melanoma
Eligibility:
All Genders
18-45 years
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 be...
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 sem...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 7 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05429138
Start Date
December 7 2022
End Date
December 1 2026
Last Update
November 18 2025
Active Locations (12)
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1
CHU de Bordeaux
Bordeaux, France
2
AP-HM
Marseille, France
3
Hôpital Saint-Joseph
Marseille, France
4
CHU Montpellier
Montpellier, France