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Идёт набор NCT07092670

MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse.

— Наблюдательное Melanoma Fertility

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dabrafenib + Trametinib, Pembrolizumab, Nivolumab, Observation.
Кому может быть актуально
Состояния в реестре: Melanoma, Fertility. Базовые параметры: до 40 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
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Официальное название

MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse. A Prospective Multicenter Observational Study

Обзор

Melanoma survivorship in reproductive-age women is increasing due to the advent of effective therapies in the curative setting. However, while the impact on fertility and ovarian function of chemotherapy agents is well known, there is still a lack of consistent data regarding novel the Mitogen-activated protein kinase (MAP) kinase pathway inhibitors and immune-checkpoint inhibitors (ICIs) used in melanoma. A recent study showed that a single course of anti-PD-1 (PD, Programmed cell death protein 1) or anti-CTLA-4 (Cytotoxic T-Lymphocyte Antigen 4) reduced both the number and quality of oocytes in mice through an immune-mediated mechanism. In particular, primordial follicle damage cannot be restored, leading to relevant clinical implications. The study aims to help to determine the impact of MAP kinase pathway inhibitors and ICIs on reproductive outcomes, and whether clinicians should discuss (and in what terms) fertility preservation techniques in reproductive-age women receiving ICIs and MAP kinase pathway inhibitors in the adjuvant setting.

Вмешательства

  • Препарат Dabrafenib + Trametinib
    There is no different use in the clinical application of the drugs reported above, the study on fertility will be implemented in the women with completely resected melanoma enrolled in the study
  • Препарат Pembrolizumab
    There is no different use in the clinical application of the drugs reported above, the study on fertility will be implemented in the women with completely resected melanoma enrolled in the study
  • Препарат Nivolumab
    There is no different use in the clinical application of the drugs reported above, the study on fertility will be implemented in the women with completely resected melanoma enrolled in the study
  • Другое Observation
    Patients who will not initiate adjuvant therapy, but will undergo observation (due to refusal, comorbidities, other reasons).

Первичные конечные точки

  • serum antimullerian hormone (AMH) [Срок оценки: 18 months after the start of therapy]
Вторичные конечные точки (1)
  • To assess long-term fertility preservation after completion of adjuvant therapy To assess the early impact on fertilitY preservation of a short course of therapy [Срок оценки: • AMH at 3 months after the start of adjuvant therapy • AMH at 12 months after the start of adjuvant therapy]

Критерии участия

Критерии включения

  • Stage II, III, IV completely resected melanoma
  • Female sex
  • Under 40 years of age
  • Not previously treated with chemotherapy and/or radiotherapy
  • Being able to give written informed consent.

Критерии исключения

  • Unresectable melanoma
  • Predisposing conditions for infertility
  • Early menopause or family history of early ovarian failure (idiopathic, < 45 years)
  • Previous bilateral ovariectomy or other ovarian surgery
  • Personal history of autoimmune diseases, endocrine disorders (except for hypothyroidism)
  • Personal history of severe mental disorders associated with infertility (e.g., nervous anorexia) and/or requiring treatments that could impair fertility
  • Inability to give written informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 10 центров
  • Ospedale Oncologico "Giovanni Paolo II" — Bari
  • IRCCS Ospedale Policlinico San Martino, Oncologia Medica 2 — Genova
  • Fondazione IRCCS Istituto Nazionale dei Tumori — Milan
  • Azienda Ospedaliero-Universitaria, Modena — Modena
  • Istituto Nazionale Tumori "Fondazione Pascale" — Naples
  • IOV Istituto Oncologico Veneto — Padova
  • Azienda Ospedaliera Santa Maria della Misericordia - Unità di Oncologia Medica. — Perugia
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma
  • … и ещё 2 центра

Идентификаторы

NCT: NCT07092670 · MELAFERT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗