Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Other
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
View:

• 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

Locations
Other Locations
France
CHU de Bordeaux
RECRUITING
Bordeaux
AP-HM
RECRUITING
Marseille
Hôpital Saint-Joseph
NOT_YET_RECRUITING
Marseille
CHU Montpellier
RECRUITING
Montpellier
CHU de Nantes
RECRUITING
Nantes
CHU NICE L'archet
NOT_YET_RECRUITING
Nice
CHRU de Nîmes
RECRUITING
Nîmes
APHP- Ambroise Paré
NOT_YET_RECRUITING
Paris
APHP-Cochin
NOT_YET_RECRUITING
Paris
APHP-Saint Louis
NOT_YET_RECRUITING
Paris
Oncôpole de Toulouse
RECRUITING
Toulouse
Institut Gustave Roussy
NOT_YET_RECRUITING
Villejuif
Contact Information
Primary
Nausicaa Malissen, MD, PhD
nausicaa.malissen@ap-hm.fr
0491384215
Backup
DRSMR AP-HM
promotion.interne@ap-hm.fr
Time Frame
Start Date: 2022-12-07
Estimated Completion Date: 2026-12
Participants
Target number of participants: 80
Treatments
Immunotherapy cohort
Patient that received adjuvant immunotherapy
Targeted therapy
Patient that received adjuvant targeted therapy
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique Hopitaux De Marseille

This content was sourced from clinicaltrials.gov