PREgnancy and FERtility Registry

NCT02895165 · tracked via the Priya Life Science Italy tracker

Sponsor

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Phase

Observational

Started

2012-11

Last updated

2026-04-30

Condition(s) studied

Breast NeoplasmsPregnancyFertility Preservation

Study 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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

45 Years

Healthy volunteers

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

Primary outcome measure(s)

Rate of patients interested in the available strategies for fertility preservation — 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
Reasons for refusal of the available strategies for fertility preservation — 15 years
Assessed through an open questionnaire
Type of anticancer therapies administered during pregnancy — 15 years
Assessed through medical records
Safety: pregnancy complications — 15 years
Assessed through medical records
Safety: incidence of adverse events — 15 years
Assessed through medical records
Disease-free survival — 15 years
Overall survival — 15 years

Trial sites (23)

Facility	City	Region	Status
Ospedale Cardinal Massaia	Asti	Asti	Recruiting
Presidio Ospedaliero 'Antonio Perrino'	Brindisi	BR	Recruiting
AOU di Cagliari Strada	Monserrato	Cagliari	Active Not Recruiting
Azienda Ospedaliera S. Croce e Carle	Cuneo	CN	Recruiting
Arcispedale S. Anna - A.O.U. di Ferrara	Cona	FE	Recruiting
Irccs Aou San Martino - Ist	Genoa	GE	Recruiting
Ospedale Vito Fazzi	Lecce	LE	Recruiting
Ospedale Unico Versilia	Lido di Camaiore	LU	Recruiting
Azienda Ospedaliera Carlo Poma	Mantua	MN	Recruiting
Ospedale 'Guglielmo da Saliceto'	Piacenza	PC	Active Not Recruiting
AOU Pisana - Ospedale S. Chiara	Pisa	Pisa	Recruiting
Fondazione S. Maugeri IRCCS	Pavia	PV	Recruiting
Azienda Ospedaliera S. Carlo	Potenza	PZ	Recruiting
Arcispedale Santa Maria Nuova di Reggio Emilia	Reggio Emilia	Reggio Emilia	Recruiting
Istituto Regina Elena per lo studio e la cura dei tumori	Roma	RM	Active Not Recruiting
Azienda Ospedaliera n. 1 - Annunziata	Sassari	SS	Recruiting
Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo	Candiolo	TO	Recruiting
ASS1 Triestina	Trieste	Trieste	Recruiting
AOU SM Misericordia	Udine	UD	Recruiting
Ospedale Sacro Cuore Don Calabria	Negrar	VE	Recruiting
A.O.U. Federico II	Naples	Italy	Recruiting
Istituto Nazionale dei Tumori - Fondazione G.Pascale	Naples	Italy	Recruiting
Ospedale Santa Maria della Misericordia	Perugia	Italy	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02895165 on ClinicalTrials.gov ↗ ← All trials in Italy