Registry of women with breast cancer during or after pregnancy
An Ambispective Observational Registry Study of Pregnancy and Breast Cancer
This study is trying to learn more about breast cancer in women who are pregnant or have been pregnant, by collecting information and samples from them to see how different factors might affect their cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Spanish Breast Cancer Research Group Academic / other |
| Locations | 28 sites (Oviedo, Asturias and 27 other locations) |
| Trial ID | NCT04603820 on ClinicalTrials.gov |
What this trial studies
This is an ambispective observational registry study that aims to collect data on women with breast cancer in three specific scenarios: those diagnosed during pregnancy, those who become pregnant after a breast cancer diagnosis, and those who have undergone fertility preservation techniques prior to treatment. The study will gather clinical characteristics and high-quality molecular data from biological samples to evaluate associations between breast cancer subtypes and various risk factors. It will enroll patients over a minimum recruitment period of three years, allowing for both retrospective and prospective data collection. The study is designed to enhance understanding of breast cancer in the context of pregnancy and fertility.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with breast cancer diagnosed during pregnancy, those who become pregnant after treatment, or those who have utilized fertility preservation methods.
Not a fit: Patients with breast cancer who do not fall into the specified categories or who are under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the management of breast cancer in pregnant women and those wishing to conceive post-diagnosis.
How similar studies have performed: While there have been studies on breast cancer and pregnancy, this registry approach is relatively novel and aims to fill gaps in existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Oviedo, Asturias and 27 other locations
- Hospital Central de Asturias — Oviedo, Asturias, Spain (Recruiting)
- Hospital Universitari Germans Trias i Pujol — Badalona, Barcelona, Spain (Recruiting)
- Hospital Universitario Mutua de Terrassa — Terrassa, Barcelona, Spain (Recruiting)
- Hospital Universitario de Basurto — Bilbao, Bizkaia, Spain (Recruiting)
- Hospital Unviersitari Son Espases — Palma De Mallorca, Islas Baleares, Spain (Recruiting)
- Hospital Nuestra Señora de la Candelaria — Santa Cruz De Tenerife, Islas Canarias, Spain (Recruiting)
- Complejo Hospitalario de Galicia (CHUAC) — A Coruña, La Coruña, Spain (Recruiting)
- Hospital Universitario Doctor Negrín — Las Palmas De Gran Canaria, Las Palmas, Spain (Recruiting)
- Hospital Universitario Severo Ochoa — Leganés, Madrid, Spain (Recruiting)
- Hospital Universitario Puerta de Hierro — Majadahonda, Madrid, Spain (Recruiting)
- Hospital Clínico Universitario Virgen de la Arrixaca — El Palmar, Murcia, Spain (Recruiting)
- Complejo Hospitalario de Navarra — Pamplona, Navarra, Spain (Recruiting)
- Hospital General Universitario de Albacete — Albacete, Spain (Recruiting)
- Hospital General Universitario de Alicante — Alicante, Spain (Recruiting)
- Hospital del Mar — Barcelona, Spain (Recruiting)
- Hospital Clinic i Provincial — Barcelona, Spain (Recruiting)
- Hospital San Pedro de Alcántara — Cáceres, Spain (Recruiting)
- Complejo Hospitalario Reina Sofía — Córdoba, Spain (Recruiting)
- Hospital Universitario San Cecilio — Granada, Spain (Recruiting)
- Hospital General Universitario Gregorio Marañón — Madrid, Spain (Recruiting)
- Hospital Clínico San Carlos — Madrid, Spain (Recruiting)
- Hospital Universitario de Salamanca — Salamanca, Spain (Recruiting)
- Hospital Universitario Virgen del Rocío — Sevilla, Spain (Recruiting)
- Hospital Virgen de la Salud de Toledo — Toledo, Spain (Recruiting)
- Instituto Valenciano de Oncología — Valencia, Spain (Recruiting)
- Hospital Clínico Universitario de Valencia — Valencia, Spain (Recruiting)
- Hospital Universitari i Politecnic La Fè — Valencia, Spain (Recruiting)
- Hospital Universitario Miguel Servet — Zaragoza, Spain (Recruiting)
Study contacts
- Study coordinator: Study Project Manager
- Email: inicio_ensayos@geicam.org
- Phone: 0034 916892870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.