Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Clinical Research Technology S.r.l. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients interested in the available strategies for fertility preservation | Assessed through medical records | 15 years |
| Rate of patients undergoing the different strategies for fertility preservation | Assessed through medical records | 15 years |
| Type of strategies for fertility preservation proposed by oncologists | Assessed through medical records | 15 years |
| Reasons for refusal of the available strategies for fertility preservation | Assessed through an open questionnaire | 15 years |
| Type of anticancer therapies administered during pregnancy | Assessed through medical records | 15 years |
| Safety: pregnancy complications | Assessed through medical records | 15 years |
| Safety: incidence of adverse events | Assessed through medical records | 15 years |
| Disease-free survival | 15 years | |
| Overall survival |
| Measure | Description | Time Frame |
|---|---|---|
| Success of the available strategies for fertility preservation: rate of recovery of ovarian function after antitumor treatments | 15 years | |
| Success of the available strategies for fertility preservation: number of oocytes collected and cryopreserved | 15 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Young breast cancer patients facing fertility and pregnancy issues
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucia Del Mastro, MD | Contact | +390105558908 | lucia.delmastro@hsanmartino.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Cardinal Massaia | Recruiting | Asti | Asti | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28526012 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 15 years |
| Success of the available strategies for fertility preservation: number of pregnancies achieved after breast cancer treatments | 15 years |
| 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 |
| Obstetrical and paediatric care of children born after prior in utero exposure to anticancer treatments | Assessed using obstetric and paediatric medical records | 15 years |
| Obstetrical and paediatric care of children born in breast cancer survivors | Assessed using obstetric and paediatric medical records | 15 years |
| Presidio Ospedaliero 'Antonio Perrino' | Recruiting | Brindisi | BR | 72100 | Italy |
|
| AOU di Cagliari Strada | Active, not recruiting | Monserrato | Cagliari | Italy |
| Azienda Ospedaliera S. Croce e Carle | Recruiting | Cuneo | CN | 12100 | Italy |
|
| Arcispedale S. Anna - A.O.U. di Ferrara | Recruiting | Cona | FE | 44124 | Italy |
|
| Irccs Aou San Martino - Ist | Recruiting | Genoa | GE | 16132 | Italy |
|
| Ospedale Vito Fazzi | Recruiting | Lecce | LE | 73100 | Italy |
|
| Ospedale Unico Versilia | Recruiting | Lido di Camaiore | LU | 55041 | Italy |
|
| Azienda Ospedaliera Carlo Poma | Recruiting | Mantua | MN | 46100 | Italy |
|
| Ospedale 'Guglielmo da Saliceto' | Active, not recruiting | Piacenza | PC | 29121 | Italy |
| AOU Pisana - Ospedale S. Chiara | Recruiting | Pisa | Pisa | Italy |
|
| Fondazione S. Maugeri IRCCS | Recruiting | Pavia | PV | 27100 | Italy |
|
| Azienda Ospedaliera S. Carlo | Recruiting | Potenza | PZ | 85100 | Italy |
|
| Arcispedale Santa Maria Nuova di Reggio Emilia | Recruiting | Reggio Emilia | Reggio Emilia | Italy |
|
| Istituto Regina Elena per lo studio e la cura dei tumori | Active, not recruiting | Roma | RM | 00144 | Italy |
| Azienda Ospedaliera n. 1 - Annunziata | Recruiting | Sassari | SS | 07100 | Italy |
|
| Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo | Recruiting | Candiolo | TO | 10060 | Italy |
|
| ASS1 Triestina | Recruiting | Trieste | Trieste | Italy |
|
| AOU SM Misericordia | Recruiting | Udine | UD | Italy |
|
| Ospedale Sacro Cuore Don Calabria | Recruiting | Negrar | VE | 37024 | Italy |
|
| A.O.U. Federico II | Recruiting | Naples | 80131 | Italy |
|
| Istituto Nazionale dei Tumori - Fondazione G.Pascale | Recruiting | Naples | 80131 | Italy |
|
| Ospedale Santa Maria della Misericordia | Recruiting | Perugia | Italy |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided