Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma

NCT05429138 | Recruiting

• 1 other identifier: 2021-A02601-40
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 12

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 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

Melanoma

Keywords

melanoma; ovarian reserv; semen parameters; fertility; adjuvant

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (4)

• measurement of biological parameters : 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

  T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.

• measurement of biological parameters : Change in sperm count

  T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.

• measurement of biological parameters : Change in sperm motility count

  T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.

Other Outcomes (1)

• measurement of biological parameters : change in sperm morphology

  T0 = Day 0 = treatment initiation; T1 = Day0 + 12 months; T2 = T1 + 12 months.

Study Arms (2)

Immunotherapy cohort

Patient that received adjuvant immunotherapy

Other: biological sampling

Targeted therapy

Patient that received adjuvant targeted therapy

Other: biological sampling

Interventions

biological sampling OTHER

Biological sampling: blood and semen

Immunotherapy cohort; Targeted therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (12)

CHU de Bordeaux

Bordeaux, France

RECRUITING

AP-HM

Marseille, France

RECRUITING

Hôpital Saint-Joseph

Marseille, France

RECRUITING

CHU Montpellier

Montpellier, France

RECRUITING

CHU de Nantes

Nantes, France

RECRUITING

CHU NICE L'archet

Nice, France

RECRUITING

CHRU de Nîmes

Nîmes, France

RECRUITING

APHP- Ambroise Paré

Paris, France

RECRUITING

APHP-Cochin

Paris, France

RECRUITING

APHP-Saint Louis

Paris, France

RECRUITING

Oncôpole de Toulouse

Toulouse, France

RECRUITING

Institut Gustave Roussy

Villejuif, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and semen

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nausicaa Malissen, MD, PhD

  AP-HM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nausicaa Malissen, MD, PhD

CONTACT

0491384215; nausicaa.malissen@ap-hm.fr

DRSMR AP-HM

CONTACT

promotion.interne@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: June 23, 2022
• Study Start: December 7, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)