PREgnancy and FERtility Registry

Last updated: May 7, 2024
Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy

Treatment

N/A

Clinical Study ID

NCT02895165
001377;000650
  • Ages 18-45
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • breast cancer diagnosis
  • age between18 and 45 years (only for PREFER-FERTILITY)
  • have not received any radiation or chemotherapy for cancer before enrolment (only forPREFER-FERTILITY)
  • absence of metastatic disease (only for PREFER-FERTILITY)
  • diagnosis of breast cancer during pregnancy or within 1 year from the end of pregnancyor pregnancy after prior diagnosis and treatment for breast cancer (only forPREFER-PREGNANCY)
  • informed consent

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 1000
Study Start date:
November 01, 2012
Estimated Completion Date:
November 30, 2032

Connect with a study center

  • Presidio Ospedaliero 'Antonio Perrino'

    Brindisi, BR 72100
    Italy

    Active - Recruiting

  • Azienda Ospedaliera S. Croce e Carle

    Cuneo, CN 12100
    Italy

    Active - Recruiting

  • AOU di Cagliari Strada

    Monserrato, Cagliari
    Italy

    Site Not Available

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

    Cona, FE 44124
    Italy

    Active - Recruiting

  • Irccs Aou San Martino - Ist

    Genoa, GE 16132
    Italy

    Active - Recruiting

  • Ospedale Vito Fazzi

    Lecce, LE 73100
    Italy

    Active - Recruiting

  • Ospedale Unico Versilia

    Lido di Camaiore, LU 55041
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Carlo Poma

    Mantova, MN 46100
    Italy

    Active - Recruiting

  • Ospedale 'Guglielmo da Saliceto'

    Piacenza, PC 29121
    Italy

    Site Not Available

  • Fondazione S. Maugeri IRCCS

    Pavia, PV 27100
    Italy

    Active - Recruiting

  • Azienda Ospedaliera S. Carlo

    Potenza, PZ 85100
    Italy

    Active - Recruiting

  • Istituto Regina Elena per lo studio e la cura dei tumori

    Roma, RM 00144
    Italy

    Site Not Available

  • Azienda Ospedaliera n. 1 - Annunziata

    Sassari, SS 07100
    Italy

    Active - Recruiting

  • Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo

    Candiolo, TO 10060
    Italy

    Active - Recruiting

  • AOU SM Misericordia

    Udine, UD
    Italy

    Active - Recruiting

  • Ospedale Sacro Cuore Don Calabria

    Negrar, VE 37024
    Italy

    Active - Recruiting

  • Ospedale Cardinal Massaia

    Asti,
    Italy

    Active - Recruiting

  • A.O.U. Federico II

    Napoli, 80131
    Italy

    Active - Recruiting

  • Istituto Nazionale dei Tumori - Fondazione G.Pascale

    Napoli, 80131
    Italy

    Active - Recruiting

  • Ospedale Santa Maria della Misericordia

    Perugia,
    Italy

    Active - Recruiting

  • AOU Pisana - Ospedale S. Chiara

    Pisa,
    Italy

    Active - Recruiting

  • Arcispedale Santa Maria Nuova di Reggio Emilia

    Reggio Emilia,
    Italy

    Active - Recruiting

  • ASS1 Triestina

    Trieste,
    Italy

    Active - Recruiting

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