About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
inability to provide written informed consent
stage IV disease at diagnosis (only for PREFER-FERTILITY)
serious psychiatric disorders
Trial population
Young breast cancer patients facing fertility and pregnancy issues
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Rate of patients interested in the available strategies for fertility preservation
Assessed through medical records
Rate of patients undergoing the different strategies for fertility preservation
Assessed through medical records
Type of strategies for fertility preservation proposed by oncologists
Assessed through medical records
Reasons for refusal of the available strategies for fertility preservation
Assessed through an open questionnaire
Secondary outcomes
Success of the available strategies for fertility preservation: rate of recovery of ovarian function after antitumor treatments
Success of the available strategies for fertility preservation: number of oocytes collected and cryopreserved
Success of the available strategies for fertility preservation: number of pregnancies achieved after breast cancer treatments
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
Sponsors and contacts
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IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Lead sponsor
Clinical Research Technology S.r.l.
Collaborator