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Spots Global Cancer Trial Database for PREgnancy and FERtility Registry

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Trial Identification

Brief Title: 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 ID: NCT02895165

Interventions

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Azienda Ospedaliera S. Carlo, Potenza, PZ, Italy

Istituto Regina Elena per lo studio e la cura dei tumori, Roma, RM, Italy

Azienda Ospedaliera n. 1 - Annunziata, Sassari, SS, Italy

Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo, Candiolo, TO, Italy

AOU SM Misericordia, Udine, UD, Italy

Ospedale Sacro Cuore Don Calabria, Negrar, VE, Italy

Ospedale Cardinal Massaia, Asti, , Italy

A.O.U. Federico II, Napoli, , Italy

Istituto Nazionale dei Tumori - Fondazione G.Pascale, Napoli, , Italy

Ospedale Santa Maria della Misericordia, Perugia, , Italy

AOU Pisana - Ospedale S. Chiara, Pisa, , Italy

Arcispedale Santa Maria Nuova di Reggio Emilia, Reggio Emilia, , Italy

ASS1 Triestina, Trieste, , Italy

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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