Clinical trial NCT02895165: PREgnancy and FERtility Registry
Official title: An Italian Multicenter Prospective Cohort Study on Fertility Preservation and Pregnancy Issues in Young Breast Cancer Patients: PREgnancy and FERtilty (PREFER)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Neoplasms
Pregnancy
Fertility Preservation
Keywords: breast neoplasms
fertility preservation
pregnancy
Lead sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Sponsor class: OTHER
Collaborators: name: Clinical Research Technology S.r.l.
First posted: 2016-09-09
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young breast cancer patients facing fertility and pregnancy issues

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.


Eligibility criteria: 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 outcomes:
measure: Rate of patients interested in the available strategies for fertility preservation
timeFrame: 15 years
measure: Rate of patients undergoing the different strategies for fertility preservation
timeFrame: 15 years
measure: Type of strategies for fertility preservation proposed by oncologists
timeFrame: 15 years
measure: Reasons for refusal of the available strategies for fertility preservation
timeFrame: 15 years
measure: Type of anticancer therapies administered during pregnancy
timeFrame: 15 years
measure: Safety: pregnancy complications
timeFrame: 15 years
measure: Safety: incidence of adverse events
timeFrame: 15 years
measure: Disease-free survival
timeFrame: 15 years
measure: Overall survival
timeFrame: 15 years
Secondary outcomes:
measure: Success of the available strategies for fertility preservation: rate of recovery of ovarian function after antitumor treatments
timeFrame: 15 years
measure: Success of the available strategies for fertility preservation: number of oocytes collected and cryopreserved
timeFrame: 15 years
measure: Success of the available strategies for fertility preservation: number of pregnancies achieved after breast cancer treatments
timeFrame: 15 years
measure: Serum hormonal changes during chemotherapy and study follow up
timeFrame: 15 years
measure: Obstetrical and paediatric care of children born after prior in utero exposure to anticancer treatments
timeFrame: 15 years
measure: Obstetrical and paediatric care of children born in breast cancer survivors
timeFrame: 15 years
Other outcomes:
Locations:
city: Brindisi
country: Italy
facility: Presidio Ospedaliero 'Antonio Perrino'
state: BR
city: Monserrato
country: Italy
facility: AOU di Cagliari Strada
state: Cagliari
city: Cuneo
country: Italy
facility: Azienda Ospedaliera S. Croce e Carle
state: CN
city: Cona
country: Italy
facility: Arcispedale S. Anna - A.O.U. di Ferrara
state: FE
city: Genoa
country: Italy
facility: Irccs Aou San Martino - Ist
state: GE
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
state: LE
city: Lido di Camaiore
country: Italy
facility: Ospedale Unico Versilia
state: LU
city: Mantova
country: Italy
facility: Azienda Ospedaliera Carlo Poma
state: MN
city: Piacenza
country: Italy
facility: Ospedale 'Guglielmo da Saliceto'
state: PC
city: Pavia
country: Italy
facility: Fondazione S. Maugeri IRCCS
state: PV
city: Potenza
country: Italy
facility: Azienda Ospedaliera S. Carlo
state: PZ
city: Roma
country: Italy
facility: Istituto Regina Elena per lo studio e la cura dei tumori
state: RM
city: Sassari
country: Italy
facility: Azienda Ospedaliera n. 1 - Annunziata
state: SS
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo
state: TO
city: Udine
country: Italy
facility: AOU SM Misericordia
state: UD
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore Don Calabria
state: VE
city: Asti
country: Italy
facility: Ospedale Cardinal Massaia
city: Napoli
country: Italy
facility: A.O.U. Federico II
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori - Fondazione G.Pascale
city: Perugia
country: Italy
facility: Ospedale Santa Maria della Misericordia
city: Pisa
country: Italy
facility: AOU Pisana - Ospedale S. Chiara
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova di Reggio Emilia
city: Trieste
country: Italy
facility: ASS1 Triestina
Study officials:
References:
citation: Lambertini M, Anserini P, Fontana V, Poggio F, Iacono G, Abate A, Levaggi A, Miglietta L, Bighin C, Giraudi S, D'Alonzo A, Blondeaux E, Buffi D, Campone F, Merlo DF, Del Mastro L. The PREgnancy and FERtility (PREFER) study: an Italian multicenter prospective cohort study on fertility preservation and pregnancy issues in young breast cancer patients. BMC Cancer. 2017 May 19;17(1):346. doi: 10.1186/s12885-017-3348-8.