PREgnancy and FERtility Registry

Pregnancy Clinical Trial

— PREFER  

Official title:

An Italian Multicenter Prospective Cohort Study on Fertility Preservation and Pregnancy Issues in Young Breast Cancer Patients: PREgnancy and FERtilty (PREFER)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02895165
• Other study ID #: 001377;000650
• Status: Recruiting
• Start date: November 2012
• Est. completion date: November 2032

Study information

• Verified date: May 2022
• Source: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Contact: Lucia Del Mastro, MD
• Phone: +390105558908
• Email: lucia.delmastro[@]hsanmartino.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 2032
• Est. primary completion date: November 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Fertility Preservation
• Pregnancy

Locations

Country	Name	City	State
Italy	Ospedale Cardinal Massaia	Asti
Italy	Presidio Ospedaliero 'Antonio Perrino'	Brindisi	BR
Italy	Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo	Candiolo	TO
Italy	Arcispedale S. Anna - A.O.U. di Ferrara	Cona	FE
Italy	Azienda Ospedaliera S. Croce e Carle	Cuneo	CN
Italy	Irccs Aou San Martino - Ist	Genoa	GE
Italy	Ospedale Vito Fazzi	Lecce	LE
Italy	Ospedale Unico Versilia	Lido di Camaiore	LU
Italy	Azienda Ospedaliera Carlo Poma	Mantova	MN
Italy	AOU di Cagliari Strada	Monserrato	Cagliari
Italy	A.O.U. Federico II	Napoli
Italy	Istituto Nazionale dei Tumori - Fondazione G.Pascale	Napoli
Italy	Ospedale Sacro Cuore Don Calabria	Negrar	VE
Italy	Fondazione S. Maugeri IRCCS	Pavia	PV
Italy	Ospedale Santa Maria della Misericordia	Perugia
Italy	Ospedale 'Guglielmo da Saliceto'	Piacenza	PC
Italy	AOU Pisana - Ospedale S. Chiara	Pisa
Italy	Azienda Ospedaliera S. Carlo	Potenza	PZ
Italy	Arcispedale Santa Maria Nuova di Reggio Emilia	Reggio Emilia
Italy	Istituto Regina Elena per lo studio e la cura dei tumori	Roma	RM
Italy	Azienda Ospedaliera n. 1 - Annunziata	Sassari	SS
Italy	ASS1 Triestina	Trieste
Italy	AOU SM Misericordia	Udine	UD

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy	Clinical Research Technology S.r.l.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients interested in the available strategies for fertility preservation	Assessed through medical records	15 years
Primary	Rate of patients undergoing the different strategies for fertility preservation	Assessed through medical records	15 years
Primary	Type of strategies for fertility preservation proposed by oncologists	Assessed through medical records	15 years
Primary	Reasons for refusal of the available strategies for fertility preservation	Assessed through an open questionnaire	15 years
Primary	Type of anticancer therapies administered during pregnancy	Assessed through medical records	15 years
Primary	Safety: pregnancy complications	Assessed through medical records	15 years
Primary	Safety: incidence of adverse events	Assessed through medical records	15 years
Primary	Disease-free survival		15 years
Primary	Overall survival		15 years
Secondary	Success of the available strategies for fertility preservation: rate of recovery of ovarian function after antitumor treatments		15 years
Secondary	Success of the available strategies for fertility preservation: number of oocytes collected and cryopreserved		15 years
Secondary	Success of the available strategies for fertility preservation: number of pregnancies achieved after breast cancer treatments		15 years
Secondary	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	15 years
Secondary	Obstetrical and paediatric care of children born after prior in utero exposure to anticancer treatments	Assessed using obstetric and paediatric medical records	15 years
Secondary	Obstetrical and paediatric care of children born in breast cancer survivors	Assessed using obstetric and paediatric medical records	15 years