| NCT ID | NCT02895165 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy |
| Condition | Breast Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2012-11 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2012-11 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT02895165 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Breast Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02895165 currently recruiting?
Yes, NCT02895165 is actively recruiting participants. Contact the research team at lucia.delmastro@hsanmartino.it for enrollment information.
Where is the NCT02895165 trial being conducted?
This trial is being conducted at Asti, Italy, Brindisi, Italy, Monserrato, Italy, Cuneo, Italy and 11 additional locations.
Who is sponsoring the NCT02895165 clinical trial?
NCT02895165 is sponsored by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy. The trial plans to enroll 1,000 participants.