Actively Recruiting
Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma
Led by Assistance Publique Hopitaux De Marseille · Updated on 2025-11-18
80
Participants Needed
12
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have signed a written consent before any procedures or sampling
- Patients must have valid Health Insurance Scheme
- Female participants aged 18 to 37 years and male participants aged 18 to 45 years
- Patients must be within 2 months before starting approved adjuvant anti-PD-1 immunotherapy or neoadjuvant plus adjuvant or targeted therapy for high-risk melanoma
- Adjuvant or neoadjuvant plus adjuvant treatment must be prescribed as part of routine care
You will not qualify if you...
- Individuals deprived of liberty or under legal guardianship
- Patients unable to understand, read, or sign informed consent
- History of cytotoxic treatment before T0 that could affect studied parameters
- Males with total motile sperm count per ejaculate less than 39 million at T0
- Females with age-specific AMH level below the 10th percentile at T0
- Any condition that could jeopardize study compliance according to the Investigator
- Patients receiving investigational treatments during the study period (observational research allowed)
- Patients who changed type of adjuvant treatment during or after neoadjuvant phase due to pathological response
AI-Screening
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Trial Site Locations
Total: 12 locations
1
CHU de Bordeaux
Bordeaux, France
Actively Recruiting
2
AP-HM
Marseille, France
Actively Recruiting
3
Hôpital Saint-Joseph
Marseille, France
Actively Recruiting
4
CHU Montpellier
Montpellier, France
Actively Recruiting
5
CHU de Nantes
Nantes, France
Actively Recruiting
6
CHU NICE L'archet
Nice, France
Actively Recruiting
7
CHRU de Nîmes
Nîmes, France
Actively Recruiting
8
APHP- Ambroise Paré
Paris, France
Actively Recruiting
9
APHP-Cochin
Paris, France
Actively Recruiting
10
APHP-Saint Louis
Paris, France
Actively Recruiting
11
Oncôpole de Toulouse
Toulouse, France
Actively Recruiting
12
Institut Gustave Roussy
Villejuif, France
Actively Recruiting
Research Team
N
Nausicaa Malissen, MD, PhD
CONTACT
D
DRSMR AP-HM
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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