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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Ospedale Cardinal Massaia
Asti, Asti, Italy
RECRUITINGPresidio Ospedaliero 'Antonio Perrino'
Brindisi, BR, Italy
RECRUITINGAOU di Cagliari Strada
Monserrato, Cagliari, Italy
ACTIVE_NOT_RECRUITINGAzienda Ospedaliera S. Croce e Carle
Cuneo, CN, Italy
RECRUITINGArcispedale S. Anna - A.O.U. di Ferrara
Cona, FE, Italy
RECRUITINGIrccs Aou San Martino - Ist
Genoa, GE, Italy
RECRUITINGOspedale Vito Fazzi
Lecce, LE, Italy
RECRUITINGOspedale Unico Versilia
Lido di Camaiore, LU, Italy
RECRUITINGAzienda Ospedaliera Carlo Poma
Mantua, MN, Italy
RECRUITINGOspedale 'Guglielmo da Saliceto'
Piacenza, PC, Italy
ACTIVE_NOT_RECRUITING...and 13 more locations
Rate of patients interested in the available strategies for fertility preservation
Assessed through medical records
Time frame: 15 years
Rate of patients undergoing the different strategies for fertility preservation
Assessed through medical records
Time frame: 15 years
Type of strategies for fertility preservation proposed by oncologists
Assessed through medical records
Time frame: 15 years
Reasons for refusal of the available strategies for fertility preservation
Assessed through an open questionnaire
Time frame: 15 years
Type of anticancer therapies administered during pregnancy
Assessed through medical records
Time frame: 15 years
Safety: pregnancy complications
Assessed through medical records
Time frame: 15 years
Safety: incidence of adverse events
Assessed through medical records
Time frame: 15 years
Disease-free survival
Time frame: 15 years
Overall survival
Time frame: 15 years
Success of the available strategies for fertility preservation: rate of recovery of ovarian function after antitumor treatments
Time frame: 15 years
Success of the available strategies for fertility preservation: number of oocytes collected and cryopreserved
Time frame: 15 years
Success of the available strategies for fertility preservation: number of pregnancies achieved after breast cancer treatments
Time frame: 15 years
Serum hormonal changes during chemotherapy and study follow up
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
Time frame: 15 years
Obstetrical and paediatric care of children born after prior in utero exposure to anticancer treatments
Assessed using obstetric and paediatric medical records
Time frame: 15 years
Obstetrical and paediatric care of children born in breast cancer survivors
Assessed using obstetric and paediatric medical records
Time frame: 15 years
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