PREgnancy and FERtility Registry

NCT ID: NCT02895165

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2032-11-30

Brief Summary

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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

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Conditions

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Breast Neoplasms Pregnancy Fertility Preservation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Clinical Research Technology S.r.l.

INDUSTRY

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Lucia Del Mastro,MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Presidio Ospedaliero 'Antonio Perrino'

Brindisi, BR, Italy

Site Status RECRUITING

AOU di Cagliari Strada

Monserrato, Cagliari, Italy

Site Status ACTIVE_NOT_RECRUITING

Azienda Ospedaliera S. Croce e Carle

Cuneo, CN, Italy

Site Status RECRUITING

Arcispedale S. Anna - A.O.U. di Ferrara

Cona, FE, Italy

Site Status RECRUITING

Irccs Aou San Martino - Ist

Genoa, GE, Italy

Site Status RECRUITING

Ospedale Vito Fazzi

Lecce, LE, Italy

Site Status RECRUITING

Ospedale Unico Versilia

Lido di Camaiore, LU, Italy

Site Status RECRUITING

Azienda Ospedaliera Carlo Poma

Mantova, MN, Italy

Site Status RECRUITING

Ospedale 'Guglielmo da Saliceto'

Piacenza, PC, Italy

Site Status ACTIVE_NOT_RECRUITING

Fondazione S. Maugeri IRCCS

Pavia, PV, Italy

Site Status RECRUITING

Azienda Ospedaliera S. Carlo

Potenza, PZ, Italy

Site Status RECRUITING

Istituto Regina Elena per lo studio e la cura dei tumori

Roma, RM, Italy

Site Status ACTIVE_NOT_RECRUITING

Azienda Ospedaliera n. 1 - Annunziata

Sassari, SS, Italy

Site Status RECRUITING

Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo

Candiolo, TO, Italy

Site Status RECRUITING

AOU SM Misericordia

Udine, UD, Italy

Site Status RECRUITING

Ospedale Sacro Cuore Don Calabria

Negrar, VE, Italy

Site Status RECRUITING

Ospedale Cardinal Massaia

Asti, , Italy

Site Status RECRUITING

A.O.U. Federico II

Napoli, , Italy

Site Status RECRUITING

Istituto Nazionale dei Tumori - Fondazione G.Pascale

Napoli, , Italy

Site Status RECRUITING

Ospedale Santa Maria della Misericordia

Perugia, , Italy

Site Status RECRUITING

AOU Pisana - Ospedale S. Chiara

Pisa, , Italy

Site Status RECRUITING

Arcispedale Santa Maria Nuova di Reggio Emilia

Reggio Emilia, , Italy

Site Status RECRUITING

ASS1 Triestina

Trieste, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Lucia Del Mastro, MD

Role: CONTACT

+390105558908

Facility Contacts

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Saverio Cinieri, MD

Role: primary

00390831537219

Ornella Garrone, MD

Role: primary

00390171616350

Antonio Frassoldati, MD

Role: primary

00390532239209

Lucia Del Mastro, MD

Role: primary

00390105600387

Mariangela Ciccarese, MD

Role: primary

00390832661962

Domenico Amoroso, MD

Role: primary

003905846057208

Maria Giovanna Cavazzini, MD

Role: primary

Antonio Bernardo, MD

Role: primary

00390382592640

Domenico Bilancia, MD

Role: primary

Antonio Pazzola, MD

Role: primary

00390792061556

Filippo Montemurro, MD

Role: primary

00390119933250

Fabio Puglisi

Role: primary

Stefania Gori, MD

Role: primary

00390456013472

Testore

Role: primary

Sabino De Placido, MD

Role: primary

00390817463650

Michelino De Laurentiis, MD

Role: primary

00390815454999

Crinò

Role: primary

Michelotti

Role: primary

La Sala

Role: primary

Ceccherini

Role: primary

References

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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.

Reference Type DERIVED
PMID: 28526012 (View on PubMed)

Other Identifiers

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001377;000650

Identifier Type: -

Identifier Source: org_study_id

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