PREgnancy and FERtility Registry
- Conditions
- PregnancyFertility PreservationBreast Neoplasms
- Registration Number
- NCT02895165
- Lead Sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1000
- 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
- inability to provide written informed consent
- stage IV disease at diagnosis (only for PREFER-FERTILITY)
- serious psychiatric disorders
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Type of anticancer therapies administered during pregnancy 15 years Assessed through medical records
Rate of patients undergoing the different strategies for fertility preservation 15 years Assessed through medical records
Type of strategies for fertility preservation proposed by oncologists 15 years Assessed through medical records
Safety: incidence of adverse events 15 years Assessed through medical records
Rate of patients interested in the available strategies for fertility preservation 15 years Assessed through medical records
Overall survival 15 years Reasons for refusal of the available strategies for fertility preservation 15 years Assessed through an open questionnaire
Safety: pregnancy complications 15 years Assessed through medical records
Disease-free survival 15 years
- Secondary Outcome Measures
Name Time Method Serum hormonal changes during chemotherapy and study follow up 15 years FSH (follicle stimulating hormone), estradiol and AMH (anti-mullerian hormone) serum levels assessed at baseline, during chemotherapy, at the end of chemotherapy and every six months thereafter
Success of the available strategies for fertility preservation: rate of recovery of ovarian function after antitumor treatments 15 years Obstetrical and paediatric care of children born after prior in utero exposure to anticancer treatments 15 years Assessed using obstetric and paediatric medical records
Success of the available strategies for fertility preservation: number of pregnancies achieved after breast cancer treatments 15 years Success of the available strategies for fertility preservation: number of oocytes collected and cryopreserved 15 years Obstetrical and paediatric care of children born in breast cancer survivors 15 years Assessed using obstetric and paediatric medical records
Trial Locations
- Locations (23)
Presidio Ospedaliero 'Antonio Perrino'
🇮🇹Brindisi, BR, Italy
Azienda Ospedaliera S. Croce e Carle
🇮🇹Cuneo, CN, Italy
Ospedale Vito Fazzi
🇮🇹Lecce, LE, Italy
Irccs Aou San Martino - Ist
🇮🇹Genoa, GE, Italy
Istituto Regina Elena per lo studio e la cura dei tumori
🇮🇹Roma, RM, Italy
Azienda Ospedaliera S. Carlo
🇮🇹Potenza, PZ, Italy
Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo
🇮🇹Candiolo, TO, Italy
AOU SM Misericordia
🇮🇹Udine, UD, Italy
Ospedale Cardinal Massaia
🇮🇹Asti, Italy
Istituto Nazionale dei Tumori - Fondazione G.Pascale
🇮🇹Napoli, Italy
AOU Pisana - Ospedale S. Chiara
🇮🇹Pisa, Italy
A.O.U. Federico II
🇮🇹Napoli, Italy
Ospedale Santa Maria della Misericordia
🇮🇹Perugia, Italy
Arcispedale Santa Maria Nuova di Reggio Emilia
🇮🇹Reggio Emilia, Italy
ASS1 Triestina
🇮🇹Trieste, Italy
Arcispedale S. Anna - A.O.U. di Ferrara
🇮🇹Cona, FE, Italy
AOU di Cagliari Strada
🇮🇹Monserrato, Cagliari, 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
Ospedale Sacro Cuore Don Calabria
🇮🇹Negrar, VE, Italy
Azienda Ospedaliera n. 1 - Annunziata
🇮🇹Sassari, SS, Italy