PREgnancy and FERtility Registry
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Breast Neoplasms, Pregnancy, Fertility Preservation. Базовые параметры: 18 лет — 45 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
An Italian Multicenter Prospective Cohort Study on Fertility Preservation and Pregnancy Issues in Young Breast Cancer Patients: PREgnancy and FERtilty (PREFER)
Обзор
The PREgnancy and FERtility (PREFER) study is a comprehensive program aiming to optimize care and improve knowledge around the topics of fertility preservation and pregnancy issues in young breast cancer patients. The program was initiated at the National Institute for Cancer Research, IRCCS AOU San Martino - IST in Genova (Liguria Region, Italy) and then it has been spread to other Italian Institutions under the umbrella of the Gruppo Italiano Mammella (GIM) study group. It is composed of two distinctive studies, one assessing fertility (i.e. PREFER-FERTILITY) and the other pregnancy (PREFER-PREGNANCY) issues. Hence, two different study protocols were developed under the umbrella of the PREFER registry. PREFER-FERTILITY aims to obtain and centralize data about the preferences and choices of young cancer patients on the fertility preservation strategies available in Italy. Furthermore, it aims to assess the outcomes of patients undergoing one or more strategies for fertility preservation in terms of success of the techniques (i.e. recovery of ovarian function, number of cryopreserved oocytes, post-treatment pregnancies) and safety (i.e. long-term survival outcomes). PREFER-PREGNANCY has two main objectives: 1) to obtain and centralize data on the management of breast cancer diagnosed during pregnancy, the obstetrical and paediatric care of children born after prior in utero exposure to anticancer treatments, and the long-term survival outcomes of these patients; 2) to obtain and centralize data on the clinical outcomes of breast cancer survivors that achieve a pregnancy after prior diagnosis and treatment of breast cancer.
Первичные конечные точки
- Rate of patients interested in the available strategies for fertility preservation [Срок оценки: 15 years]
- Rate of patients undergoing the different strategies for fertility preservation [Срок оценки: 15 years]
- Type of strategies for fertility preservation proposed by oncologists [Срок оценки: 15 years]
- Reasons for refusal of the available strategies for fertility preservation [Срок оценки: 15 years]
- Type of anticancer therapies administered during pregnancy [Срок оценки: 15 years]
- Safety: pregnancy complications [Срок оценки: 15 years]
- Safety: incidence of adverse events [Срок оценки: 15 years]
- Disease-free survival [Срок оценки: 15 years]
- Overall survival [Срок оценки: 15 years]
Вторичные конечные точки (6)
- Success of the available strategies for fertility preservation: rate of recovery of ovarian function after antitumor treatments [Срок оценки: 15 years]
- Success of the available strategies for fertility preservation: number of oocytes collected and cryopreserved [Срок оценки: 15 years]
- Success of the available strategies for fertility preservation: number of pregnancies achieved after breast cancer treatments [Срок оценки: 15 years]
- Serum hormonal changes during chemotherapy and study follow up [Срок оценки: 15 years]
- Obstetrical and paediatric care of children born after prior in utero exposure to anticancer treatments [Срок оценки: 15 years]
- Obstetrical and paediatric care of children born in breast cancer survivors [Срок оценки: 15 years]
Критерии участия
Критерии включения
- breast cancer diagnosis
- age between18 and 45 years (only for PREFER-FERTILITY)
- have not received any radiation or chemotherapy for cancer before enrolment (only for PREFER-FERTILITY)
- absence of metastatic disease (only for PREFER-FERTILITY)
- diagnosis of breast cancer during pregnancy or within 1 year from the end of pregnancy or pregnancy after prior diagnosis and treatment for breast cancer (only for PREFER-PREGNANCY)
- informed consent
Критерии исключения
- inability to provide written informed consent
- stage IV disease at diagnosis (only for PREFER-FERTILITY)
- serious psychiatric disorders
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 · 23 центра
- Ospedale Cardinal Massaia — Asti
- Presidio Ospedaliero 'Antonio Perrino' — Brindisi
- AOU di Cagliari Strada — Monserrato
- Azienda Ospedaliera S. Croce e Carle — Cuneo
- Arcispedale S. Anna - A.O.U. di Ferrara — Cona
- Irccs Aou San Martino - Ist — Genoa
- Ospedale Vito Fazzi — Lecce
- Ospedale Unico Versilia — Lido di Camaiore
- … и ещё 15 центров
Публикации
- Lambertini M, Anserini P, Fontana V, Poggio F, Iacono G, Abate A, Levaggi A, Miglietta L, Bighin C, Giraudi S, D'Alonzo A, Blondeaux E, Buffi D, Campone F, Merlo DF, Del Mastro L. The PREgnancy and FERtility (PREFER) study: an Italian multicenter prospective cohort study on fertility preservation and pregnancy issues in young breast cancer patients. BMC Cancer. 2017 May 19;17(1):346. doi: 10.1186/ PMID 28526012
Идентификаторы
NCT: NCT02895165 · 001377;000650