PREgnancy and FERtility Registry
Recruiting · NCT02895165 · Observational (researchers observe without assigning treatment) · Lead sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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 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 criteria
- inability to provide written informed consent
- stage IV disease at diagnosis (only for PREFER-FERTILITY)
- serious psychiatric disorders
Where it is running
23 locations listed.
- A.O.U. Federico II - Naples, Italy
- Istituto Nazionale dei Tumori - Fondazione G.Pascale - Naples, Italy
- Ospedale Santa Maria della Misericordia - Perugia, Italy
- Ospedale Cardinal Massaia - Asti, Asti, Italy
- Presidio Ospedaliero 'Antonio Perrino' - Brindisi, BR, Italy
- Azienda Ospedaliera S. Croce e Carle - Cuneo, CN, Italy
- AOU di Cagliari Strada - Monserrato, Cagliari, 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 - Mantua, MN, Italy
- Ospedale 'Guglielmo da Saliceto' - Piacenza, PC, Italy
- Fondazione S. Maugeri IRCCS - Pavia, PV, Italy
- Azienda Ospedaliera S. Carlo - Potenza, PZ, Italy
- AOU Pisana - Ospedale S. Chiara - Pisa, Pisa, Italy
- Istituto Regina Elena per lo studio e la cura dei tumori - Roma, RM, Italy
- Arcispedale Santa Maria Nuova di Reggio Emilia - Reggio Emilia, Reggio Emilia, Italy
- Azienda Ospedaliera n. 1 - Annunziata - Sassari, SS, Italy
- Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo - Candiolo, TO, Italy
- ASS1 Triestina - Trieste, Trieste, Italy
- AOU SM Misericordia - Udine, UD, Italy
- Ospedale Sacro Cuore Don Calabria - Negrar, VE, Italy