Pregnancy Clinical Trial
— PREFEROfficial title:
An Italian Multicenter Prospective Cohort Study on Fertility Preservation and Pregnancy Issues in Young Breast Cancer Patients: PREgnancy and FERtilty (PREFER)
NCT number | NCT02895165 |
Other study ID # | 001377;000650 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 2012 |
Est. completion date | November 2032 |
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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | November 2032 |
Est. primary completion date | November 2027 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale Cardinal Massaia | Asti | |
Italy | Presidio Ospedaliero 'Antonio Perrino' | Brindisi | BR |
Italy | Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo | Candiolo | TO |
Italy | Arcispedale S. Anna - A.O.U. di Ferrara | Cona | FE |
Italy | Azienda Ospedaliera S. Croce e Carle | Cuneo | CN |
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 | AOU di Cagliari Strada | Monserrato | Cagliari |
Italy | A.O.U. Federico II | Napoli | |
Italy | Istituto Nazionale dei Tumori - Fondazione G.Pascale | Napoli | |
Italy | Ospedale Sacro Cuore Don Calabria | Negrar | VE |
Italy | Fondazione S. Maugeri IRCCS | Pavia | PV |
Italy | Ospedale Santa Maria della Misericordia | Perugia | |
Italy | Ospedale 'Guglielmo da Saliceto' | Piacenza | PC |
Italy | AOU Pisana - Ospedale S. Chiara | Pisa | |
Italy | Azienda Ospedaliera S. Carlo | Potenza | PZ |
Italy | Arcispedale Santa Maria Nuova di Reggio Emilia | Reggio Emilia | |
Italy | Istituto Regina Elena per lo studio e la cura dei tumori | Roma | RM |
Italy | Azienda Ospedaliera n. 1 - Annunziata | Sassari | SS |
Italy | ASS1 Triestina | Trieste | |
Italy | AOU SM Misericordia | Udine | UD |
Lead Sponsor | Collaborator |
---|---|
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy | Clinical Research Technology S.r.l. |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of patients interested in the available strategies for fertility preservation | Assessed through medical records | 15 years | |
Primary | Rate of patients undergoing the different strategies for fertility preservation | Assessed through medical records | 15 years | |
Primary | Type of strategies for fertility preservation proposed by oncologists | Assessed through medical records | 15 years | |
Primary | Reasons for refusal of the available strategies for fertility preservation | Assessed through an open questionnaire | 15 years | |
Primary | Type of anticancer therapies administered during pregnancy | Assessed through medical records | 15 years | |
Primary | Safety: pregnancy complications | Assessed through medical records | 15 years | |
Primary | Safety: incidence of adverse events | Assessed through medical records | 15 years | |
Primary | Disease-free survival | 15 years | ||
Primary | Overall survival | 15 years | ||
Secondary | Success of the available strategies for fertility preservation: rate of recovery of ovarian function after antitumor treatments | 15 years | ||
Secondary | Success of the available strategies for fertility preservation: number of oocytes collected and cryopreserved | 15 years | ||
Secondary | Success of the available strategies for fertility preservation: number of pregnancies achieved after breast cancer treatments | 15 years | ||
Secondary | 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 | |
Secondary | Obstetrical and paediatric care of children born after prior in utero exposure to anticancer treatments | Assessed using obstetric and paediatric medical records | 15 years | |
Secondary | Obstetrical and paediatric care of children born in breast cancer survivors | Assessed using obstetric and paediatric medical records | 15 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03442582 -
Afluria Pregnancy Registry
|
||
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Enrolling by invitation |
NCT05415371 -
Persistent Poverty Counties Pregnant Women With Medicaid
|
N/A | |
Completed |
NCT04548102 -
Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman
|
N/A | |
Completed |
NCT03218956 -
Protein Requirement During Lactation
|
N/A | |
Completed |
NCT02191605 -
Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy
|
N/A | |
Completed |
NCT02223637 -
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
|
||
Recruiting |
NCT06049953 -
Maternal And Infant Antipsychotic Study
|
||
Completed |
NCT02577536 -
PregSource: Crowdsourcing to Understand Pregnancy
|
||
Not yet recruiting |
NCT06336434 -
CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05412238 -
Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months
|
N/A | |
Not yet recruiting |
NCT04786587 -
Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
|
||
Not yet recruiting |
NCT05028387 -
Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
|
||
Completed |
NCT02683005 -
Study of Hepatitis C Treatment During Pregnancy
|
Phase 1 | |
Completed |
NCT02783170 -
Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women
|
Phase 4 | |
Recruiting |
NCT02507180 -
Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
|
||
Recruiting |
NCT02619188 -
Nutritional Markers in Normal and Hyperemesis Pregnancies
|
N/A | |
Recruiting |
NCT02564250 -
Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women
|
N/A | |
Completed |
NCT02523755 -
Evaluation of Regional Distribution of Ventilation During Labor With or Without Epidural Analgesia
|
Phase 4 |