Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Immunomodulating Agents

Patient that received adjuvant immunotherapy

Patient that received adjuvant targeted therapy

biological sampling

Rawand Masoud, PhD

DRSMR AP-HM

Caroline DUTRIAUX

Lucie Chansel-Debordeaux

Nausicaa MALISSEN

Elodie ARCHIER

Vanessa Loup

Candice Lesage

Sophie Bringer

Gaëlle QUEREUX

Florence LEPERLIER

Henri MONTAUDIE

Henri Montaudie

Emmanuelle Thibault

Pierre STOEBNER

Elisa FUNCK-BRENTANO

Michaël GRYNBERG

Bénédicte OULES

Virginie BARRAUD

Céleste LEBBE

Barouyr BAROUDJIAN

Cécile PAGES

Roger LEANDRI

Caroline Robert

Nausicaa Malissen, MD, PhD

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.

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 semen quality.

Main objective: to measure pre-treatment (T0) and immediate post-treatment (T1) evolution of anti-Müllerian hormone (AMH) levels reflecting the ovarian reserve in women, and of the total motile sperm count per ejaculate in men, in patients of childbearing age treated with anti-PD-1 immunotherapy or targeted therapies in an adjuvant situation for melanoma at high risk of recurrence.

Method: 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).

At each of their visit to CECOS (T0, T1 and T2), the women will have an AMH assay and an antral follicle count (AFC) by ultrasound while the men will perform a semen analysis (count, spermocytogram and staining with aniline blue for analysis of chromatin condensation).

A standardized questionnaire aimed at collecting data about factors that may alter fertility will be submitted at each of these visits.

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 settings.

Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma

change in sperm morphology (using spermogram)

change in Anti-Müllerian hormone (AMH) levels in women

Change in sperm motility count per ejaculate in men

change of rate of spermatozoids with sperm chromatin abnormalities

Change in sperm count (spermogram) during time

Change in sperm motility count (spermogram)

Assistance Publique Hopitaux De Marseille

Gland and Hormone Related Diseases

Endocrine Gland Neoplasms

Endocrine System Diseases

Gastrointestinal Agents

Antineoplastic Agents

Pancrelipase

Pancreatin

Lanreotide

naive patient with digestive neuroendocrine tumor (pancreas or small intestine), initiating Lanreotide treatment

Historical control group (retrospective data) Patients, with normal endoscopic and body imaging results, having had fecal ARN16s sequencing who were assigned as control subjects for microbiota analyses.

Blood sample (5mL) for metabolomic dosage and Fecal sample for ARN16s sequencing

Biological sampling

IRADJ SOBHANI, MD-PHD

Incidence of digestive neuroendocrine tumors are increasing. Analysis of individual microbiota is a way to explore new neoplastic mechanisms, tumor identification and therapeutic orientations. This prospective pilot study aims to describe fecal bacterial phylogeny of patients with digestive neuroendocrine tumor.

Bacterial genomic signature will be recorded at initiation of Lanreotide treatment in naive patient with digestive neuroendocrine tumor (pancreas or small intestine), metastatic or locally advanced, as well as after one year follow up.

fecal sample blood sample

blood sample is part of routine medical care and fecal sample is a non invasive collection of elements from human body, allowing the study to be categorised as a non-interventional research (approved by ethics commitee)

Please see:

"Arrêté du 12 avril 2018 fixant la liste des recherches mentionnées au 3° de l'article L. 1121-1 du code de la santé publique" , justifying observational study type

Microbiotic Analysis in Digestive Endocrine Tumors

Data are own by Assistance Publique - Hopitaux de Paris, please contact sponsor for further information

bacterial genomic signature by fecal ARN16S analysis at enrollment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma	NCT05429138	Melanoma	biological samp...	18 Years - 45 Years	Assistance Publique Hopitaux De Marseille
Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma	NCT05429138	Melanoma	biological samp...	18 Years - 45 Years	Assistance Publique Hopitaux De Marseille
Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma	NCT05429138	Melanoma	biological samp...	18 Years - 45 Years	Assistance Publique Hopitaux De Marseille
Microbiotic Analysis in Digestive Endocrine Tumors	NCT04198402	Digestive Neuro... Fecal Microbiot... Bacterial Signa...	Biological samp...	18 Years -	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for biological sampling