PREgnancy and FERtility Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorIRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Rate of patients interested in the available strategies for fertility preservation

Assessed through medical records

Time frame
15 years
2

Rate of patients undergoing the different strategies for fertility preservation

Assessed through medical records

Time frame
15 years
3

Type of strategies for fertility preservation proposed by oncologists

Assessed through medical records

Time frame
15 years
4

Reasons for refusal of the available strategies for fertility preservation

Assessed through an open questionnaire

Time frame
15 years

Secondary outcomes

1

Success of the available strategies for fertility preservation: rate of recovery of ovarian function after antitumor treatments

Time frame
15 years
2

Success of the available strategies for fertility preservation: number of oocytes collected and cryopreserved

Time frame
15 years
3

Success of the available strategies for fertility preservation: number of pregnancies achieved after breast cancer treatments

Time frame
15 years
4

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

Other outcomes

Sponsors and contacts

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