Spots Global Cancer Trial Database for Registry Study of Pregnancy and Breast Cancer
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Trial Identification
Brief Title: Registry Study of Pregnancy and Breast Cancer
Official Title: An Ambispective Observational Registry Study of Pregnancy and Breast Cancer
Study ID: NCT04603820
Conditions
Interventions
Study Description
Brief Summary: An ambispective observational registry study of pregnancy and breast cancer
Detailed Description: A multicenter, observational, non-post-marketing (non-PMS), ambispective (retrospective and prospective from the registry opening) study which will enroll patients with breast cancer in any of these three situations: 1. Patients with gestational breast cancer, defined as breast cancer diagnosed during pregnancy, breastfeeding or up to a year after delivery. 2. Patients who become pregnant after a breast cancer diagnosis. 3. Patients with breast cancer who have followed any fertility preservation technique prior to the start of breast cancer treatment. It is estimated a minimum recruitment period of approximately 3 years from the study activation. The study will remain open as long as possible in order to collect as much information as possible. GEICAM will actively search for funding for this. Patients may also be concurrently enrolled in an interventional clinical trial. This observational registry study of pregnancy and breast cancer that collects significant data obtained from standard clinical practice, regarding the clinical characteristics of patients with breast cancer in any of the three situations described above. These data will allow the performance of both descriptive and exploratory analyses in order to evaluate the associations between different breast cancer subtypes and risk factors observed. Finally, this study will collect high quality molecular data derived from the analysis of biological samples (paraffin-embedded tumor and peripheral blood samples) to reach a better understanding of the biological mechanisms involved in breast cancer in relation to pregnancy. No treatment regimen will be protocol specified. This is an observational study in which clinical decisions concerning the optimum management strategy for a particular patient are taken independently of and/or prior to, any decision by the physician to invite a patient to participate in the study. The treating physician will make all treatment decisions according to his/her regular clinical practice independent of this study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Hospital Central de Asturias, Oviedo, Asturias, Spain
Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital Universitario Mutua de Terrassa, Terrassa, Barcelona, Spain
Hospital Universitario de Basurto, Bilbao, Bizkaia, Spain
Hospital Unviersitari Son Espases, Palma De Mallorca, Islas Baleares, Spain
Hospital Nuestra Señora de la Candelaria, Santa Cruz De Tenerife, Islas Canarias, Spain
Complejo Hospitalario de Galicia (CHUAC), A Coruña, La Coruña, Spain
Hospital Universitario Doctor Negrín, Las Palmas De Gran Canaria, Las Palmas, Spain
Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain
Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain
Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar, Murcia, Spain
Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain
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, Sevilla, , 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
Contact Details
Name: Study Director
Affiliation: Instituto Valenciano de Oncología, Valencia, España
Role: STUDY_DIRECTOR
Name: Study Director
Affiliation: Hospital Universitario Reina Sofía de Córdoba, Córdoba, España
Role: STUDY_DIRECTOR
Name: Study Director
Affiliation: Hospital Clínico Universitario de Valencia, Valencia, España
Role: STUDY_DIRECTOR
Name: Study Director
Affiliation: Centro Nacional de Epidemiología. Instituto de Salud Carlos III, Madrid, España
Role: STUDY_DIRECTOR
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