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Trial record 1 of 1 for:    02895165
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PREgnancy and FERtility Registry (PREFER)

This study is currently recruiting participants.
Verified November 2017 by Lucia Del Mastro,MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Sponsor:
ClinicalTrials.gov Identifier:
NCT02895165
First Posted: September 9, 2016
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Clinical Research Technology S.r.l.
Information provided by (Responsible Party):
Lucia Del Mastro,MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
  Purpose

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.


Condition
Breast Neoplasms Pregnancy Fertility Preservation

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Years
Official Title: An Italian Multicenter Prospective Cohort Study on Fertility Preservation and Pregnancy Issues in Young Breast Cancer Patients: PREgnancy and FERtilty (PREFER)

Resource links provided by NLM:


Further study details as provided by Lucia Del Mastro,MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:

Primary Outcome Measures:
  • Rate of patients interested in the available strategies for fertility preservation [ Time Frame: 15 years ]
    Assessed through medical records

  • Rate of patients undergoing the different strategies for fertility preservation [ Time Frame: 15 years ]
    Assessed through medical records

  • Type of strategies for fertility preservation proposed by oncologists [ Time Frame: 15 years ]
    Assessed through medical records

  • Reasons for refusal of the available strategies for fertility preservation [ Time Frame: 15 years ]
    Assessed through an open questionnaire

  • Type of anticancer therapies administered during pregnancy [ Time Frame: 15 years ]
    Assessed through medical records

  • Safety: pregnancy complications [ Time Frame: 15 years ]
    Assessed through medical records

  • Safety: incidence of adverse events [ Time Frame: 15 years ]
    Assessed through medical records

  • Disease-free survival [ Time Frame: 15 years ]
  • Overall survival [ Time Frame: 15 years ]

Secondary Outcome Measures:
  • Success of the available strategies for fertility preservation: rate of recovery of ovarian function after antitumor treatments [ Time Frame: 15 years ]
  • Success of the available strategies for fertility preservation: number of oocytes collected and cryopreserved [ Time Frame: 15 years ]
  • Success of the available strategies for fertility preservation: number of pregnancies achieved after breast cancer treatments [ Time Frame: 15 years ]
  • Serum hormonal changes during chemotherapy and study follow up [ Time Frame: 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

  • Obstetrical and paediatric care of children born after prior in utero exposure to anticancer treatments [ Time Frame: 15 years ]
    Assessed using obstetric and paediatric medical records

  • Obstetrical and paediatric care of children born in breast cancer survivors [ Time Frame: 15 years ]
    Assessed using obstetric and paediatric medical records


Estimated Enrollment: 1000
Study Start Date: November 2012
Estimated Study Completion Date: November 2032
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Young breast cancer patients facing fertility and pregnancy issues
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02895165


Contacts
Contact: Lucia Del Mastro, MD +390105558908 lucia.delmastro@hsanmartino.it

Locations
Italy
Presidio Ospedaliero `Antonio Perrino` Recruiting
Brindisi, BR, Italy, 72100
Contact: Saverio Cinieri, MD    00390831537219    saverio.cinieri@ieo.it   
Principal Investigator: Saverio Cinieri, MD         
AOU di Cagliari Strada Active, not recruiting
Monserrato, Cagliari, Italy
Azienda Ospedaliera S. Croce e Carle Recruiting
Cuneo, CN, Italy, 12100
Contact: Ornella Garrone, MD    00390171616350    ornella.garrone@gmail.com   
Principal Investigator: Ornella Garrone, MD         
Arcispedale S. Anna - A.O.U. di Ferrara Recruiting
Cona, FE, Italy, 44124
Contact: Antonio Frassoldati, MD    00390532239209    a.frassoldati@ospfe.it   
Principal Investigator: Antonio Frassoldati, MD         
Irccs Aou San Martino - Ist Recruiting
Genoa, GE, Italy, 16132
Contact: Lucia Del Mastro, MD    00390105600387    lucia.delmastro@hsanmartino.it   
Principal Investigator: Lucia Del Mastro, MD         
Sub-Investigator: Matteo Lambertini, MD         
Ospedale Vito Fazzi Recruiting
Lecce, LE, Italy, 73100
Contact: Mariangela Ciccarese, MD    00390832661962    m.ciccarese@libero.it   
Principal Investigator: Mariangela Ciccarese, MD         
Ospedale Unico Versilia Recruiting
Lido di Camaiore, LU, Italy, 55041
Contact: Domenico Amoroso, MD    003905846057208    d.amoroso@usl12.toscana.it   
Principal Investigator: Domenico Amoroso, MD         
Azienda Ospedaliera Carlo Poma Recruiting
Mantova, MN, Italy, 46100
Contact: Maria Giovanna Cavazzini, MD         
Principal Investigator: Maria Giovanna Cavazzini, MD         
Ospedale `Guglielmo da Saliceto` Active, not recruiting
Piacenza, PC, Italy, 29121
Fondazione S. Maugeri IRCCS Recruiting
Pavia, PV, Italy, 27100
Contact: Antonio Bernardo, MD    00390382592640    antonio.bernardo@fsm.it   
Principal Investigator: Antonio Bernardo, MD         
Azienda Ospedaliera S. Carlo Recruiting
Potenza, PZ, Italy, 85100
Contact: Domenico Bilancia, MD         
Principal Investigator: Domenico Bilancia, MD         
Istituto Regina Elena per lo studio e la cura dei tumori Active, not recruiting
Roma, RM, Italy, 00144
Azienda Ospedaliera n. 1 - Annunziata Recruiting
Sassari, SS, Italy, 07100
Contact: Antonio Pazzola, MD    00390792061556    oncologia.medica@aslsassari.it   
Principal Investigator: Antonio Pazzola, MD         
Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo Recruiting
Candiolo, TO, Italy, 10060
Contact: Filippo Montemurro, MD    00390119933250    filippo.montemurro@ircc.it   
Principal Investigator: Filippo Montemurro, MD         
AOU SM Misericordia Recruiting
Udine, UD, Italy
Contact: Fabio Puglisi         
Ospedale Sacro Cuore Don Calabria Recruiting
Negrar, VE, Italy, 37024
Contact: Stefania Gori, MD    00390456013472    stefania.gori@sacrocuore.it   
Principal Investigator: Stefania Gori, MD         
Ospedale Cardinal Massaia Recruiting
Asti, Italy
Contact: Testore         
A.O.U. Federico II Recruiting
Napoli, Italy, 80131
Contact: Sabino De Placido, MD    00390817463650    studiclinici.oncologia@unina.it   
Principal Investigator: Sabino De Placido, MD         
Istituto Nazionale dei Tumori - Fondazione G.Pascale Recruiting
Napoli, Italy, 80131
Contact: Michelino De Laurentiis, MD    00390815454999    m.delaurentiis@breastunit.org   
Principal Investigator: Michelino De Laurentiis, MD         
Ospedale Santa Maria della Misericordia Recruiting
Perugia, Italy
Contact: Crinò         
AOU Pisana - Ospedale S. Chiara Recruiting
Pisa, Italy
Contact: Michelotti         
Arcispedale Santa Maria Nuova di Reggio Emilia Recruiting
Reggio Emilia, Italy
Contact: La Sala         
ASS1 Triestina Recruiting
Trieste, Italy
Contact: Ceccherini         
Sponsors and Collaborators
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Clinical Research Technology S.r.l.
  More Information

Responsible Party: Lucia Del Mastro,MD, MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
ClinicalTrials.gov Identifier: NCT02895165     History of Changes
Other Study ID Numbers: 001377;000650
First Submitted: August 22, 2016
First Posted: September 9, 2016
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Lucia Del Mastro,MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:
breast neoplasms
fertility preservation
pregnancy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases