RecruitingNCT02895165

PREgnancy and FERtility Registry

An Italian Multicenter Prospective Cohort Study on Fertility Preservation and Pregnancy Issues in Young Breast Cancer Patients: PREgnancy and FERtilty (PREFER)


Sponsor

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Enrollment

1,000 participants

Start Date

Nov 1, 2012

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria6

  • 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

Exclusion Criteria3

  • inability to provide written informed consent
  • stage IV disease at diagnosis (only for PREFER-FERTILITY)
  • serious psychiatric disorders

Locations(23)

Presidio Ospedaliero 'Antonio Perrino'

Brindisi, BR, Italy

AOU di Cagliari Strada

Monserrato, Cagliari, Italy

Azienda Ospedaliera S. Croce e Carle

Cuneo, CN, Italy

Arcispedale S. Anna - A.O.U. di Ferrara

Cona, FE, Italy

Irccs Aou San Martino - Ist

Genoa, GE, Italy

Ospedale Vito Fazzi

Lecce, LE, Italy

Ospedale Unico Versilia

Lido di Camaiore, LU, Italy

Azienda Ospedaliera Carlo Poma

Mantova, MN, Italy

Ospedale 'Guglielmo da Saliceto'

Piacenza, PC, Italy

Fondazione S. Maugeri IRCCS

Pavia, PV, Italy

Azienda Ospedaliera S. Carlo

Potenza, PZ, Italy

Istituto Regina Elena per lo studio e la cura dei tumori

Roma, RM, Italy

Azienda Ospedaliera n. 1 - Annunziata

Sassari, SS, Italy

Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo

Candiolo, TO, Italy

AOU SM Misericordia

Udine, UD, Italy

Ospedale Sacro Cuore Don Calabria

Negrar, VE, Italy

Ospedale Cardinal Massaia

Asti, Italy

A.O.U. Federico II

Napoli, Italy

Istituto Nazionale dei Tumori - Fondazione G.Pascale

Napoli, Italy

Ospedale Santa Maria della Misericordia

Perugia, Italy

AOU Pisana - Ospedale S. Chiara

Pisa, Italy

Arcispedale Santa Maria Nuova di Reggio Emilia

Reggio Emilia, Italy

ASS1 Triestina

Trieste, Italy

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NCT02895165


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