PREgnancy and FERtility Registry

Recruiting

• Conditions: Pregnancy; Fertility Preservation; Breast Neoplasms

• Registration Number: NCT02895165
• Lead Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-09-05
• Study First Posted: 2016-09-09
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2027-11
• Study Completion: 2032-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Serum hormonal changes during chemotherapy and study follow up	15 years	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
Success of the available strategies for fertility preservation: rate of recovery of ovarian function after antitumor treatments	15 years
Obstetrical and paediatric care of children born after prior in utero exposure to anticancer treatments	15 years	Assessed using obstetric and paediatric medical records
Success of the available strategies for fertility preservation: number of pregnancies achieved after breast cancer treatments	15 years
Success of the available strategies for fertility preservation: number of oocytes collected and cryopreserved	15 years
Obstetrical and paediatric care of children born in breast cancer survivors	15 years	Assessed using obstetric and paediatric medical records

Trial Locations

Locations (23)

Presidio Ospedaliero 'Antonio Perrino'; 🇮🇹 Brindisi, BR, Italy

AOU di Cagliari Strada; 🇮🇹 Monserrato, Cagliari, Italy

Azienda Ospedaliera S. Croce e Carle; 🇮🇹 Cuneo, CN, Italy

Arcispedale S. Anna - A.O.U. di Ferrara; 🇮🇹 Cona, FE, 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

Ospedale 'Guglielmo da Saliceto'; 🇮🇹 Piacenza, PC, Italy

Fondazione S. Maugeri IRCCS; 🇮🇹 Pavia, PV, Italy

Scroll for more (13 remaining)