An ambispective observational registry study of pregnancy and breast cancer
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. The patient should have signed and dated the informed consent form (ICF). The enrollment of patients who have died is allowed.
2. Women aged ≥ 18 years.
3. Patients in one of the following situations:
* Patients with breast cancer diagnosis during pregnancy, breastfeeding or within the year after delivery.
* Patients with breast cancer who become pregnant after treatment.
* Patients with breast cancer who were subjected to any fertility preservation method prior to the start of breast cancer treatment.
4. The patients referred to in the previous section and the patients who meet these characteristics prospectively could be enrolled retrospectively upon registry opening.
5. All cases diagnosed at the same site may be included. In order to prevent duplications, in case the patient followed her treatment and follow-up at another site, she will be enrolled as per the site where the diagnosis was made, requesting information of the treatment and progression, when possible.
6. Availability of clinical, epidemiological and progress data.
Exclusion Criteria:
Patients who do not wish to participate in the study for any reason could not be included in the study.
Primary outcome measure(s)
Number of participants with breast cancer diagnosis during the gestation, breastfeeding, first year after the delivery (not during breastfeeding period), after a pregnancy and followed by any fertility preservation method before the anticancer treatment — Baseline visit Data for this study will be recorded into the electronic case report form (eCRF) via web using Remote Data Capture (RDC) from Oracle Clinical®. Once patient has signed the ICF or verified that the data of deceased patients can be included, designated site personnel will complete the register of each patient in the eCRF, where an identification number will automatically be assigned.
Data will be recorded in the eCRF at the time of patient enrollment and approximately every year.
Race of participants with breast cancer diagnosis during the gestation, breastfeeding, first year after the delivery (not during breastfeeding period), after a pregnancy and followed by any fertility preservation method before the anticancer treatment — Baseline visit Data for this study will be recorded into the eCRF via web using RDC (Remote Data Capture) from Oracle Clinical®. Once patient has signed the ICF or verified that the data of deceased patients can be included, designated site personnel will complete the register of each patient in the eCRF, where an identification number will automatically be assigned.
Data will be recorded in the eCRF at the time of patient enrollment and approximately every year.
Age of participants with breast cancer diagnosis during the gestation, breastfeeding, first year after the delivery (not during breastfeeding period), after a pregnancy and followed by any fertility preservation method before the anticancer treatment — Baseline visit Data for this study will be recorded into the eCRF via web using RDC (Remote Data Capture) from Oracle Clinical®. Once patient has signed the ICF or verified that the data of deceased patients can be included, designated site personnel will complete the register of each patient in the eCRF, where an identification number will automatically be assigned.
Data will be recorded in the eCRF at the time of patient enrollment and approximately every year.
Trial sites (28)
Facility
City
Region
Status
Hospital Unviersitari Son Espases
Palma de Mallorca
Balearic Islands
Hospital Universitari Germans Trias i Pujol
Badalona
Barcelona
Hospital Universitario Mutua de Terrassa
Terrassa
Barcelona
Hospital Universitario de Basurto
Bilbao
Bizkaia
Hospital Nuestra Señora de la Candelaria
Santa Cruz de Tenerife
Canary Islands
Complejo Hospitalario de Galicia (CHUAC)
A Coruña
La Coruña
Hospital Universitario Doctor Negrín
Las Palmas de Gran Canaria
Las Palmas
Hospital Universitario Severo Ochoa
Leganés
Madrid
Hospital Universitario Puerta de Hierro
Majadahonda
Madrid
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar
Murcia
Complejo Hospitalario de Navarra
Pamplona
Navarre
Hospital Central de Asturias
Oviedo
Principality of Asturias
Hospital General Universitario de Albacete
Albacete
Spain
Hospital General Universitario de Alicante
Alicante
Spain
Hospital del Mar
Barcelona
Spain
Hospital Clinic i Provincial
Barcelona
Spain
Hospital San Pedro de Alcántara
Cáceres
Spain
Complejo Hospitalario Reina Sofía
Córdoba
Spain
Hospital Universitario San Cecilio
Granada
Spain
Hospital General Universitario Gregorio Marañón
Madrid
Spain
Hospital Clínico San Carlos
Madrid
Spain
Hospital Universitario de Salamanca
Salamanca
Spain
Hospital Universitario Virgen del Rocío
Seville
Spain
Hospital Virgen de la Salud de Toledo
Toledo
Spain
Instituto Valenciano de Oncología
Valencia
Spain
Hospital Clínico Universitario de Valencia
Valencia
Spain
Hospital Universitari i Politecnic La Fè
Valencia
Spain
Hospital Universitario Miguel Servet
Zaragoza
Spain
More Spanish Breast Cancer Research Group trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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