Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
866 participants
OBSERVATIONAL
2019-11-18
2030-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
OTHER
Eligibility Criteria
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Inclusion Criteria
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
18 Years
FEMALE
No
Sponsors
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Spanish Breast Cancer Research Group
OTHER
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Instituto Valenciano de Oncología, Valencia, España
Study Director
Role: STUDY_DIRECTOR
Hospital Universitario Reina Sofía de Córdoba, Córdoba, España
Study Director
Role: STUDY_DIRECTOR
Hospital Clínico Universitario de Valencia, Valencia, España
Study Director
Role: STUDY_DIRECTOR
Centro Nacional de Epidemiología. Instituto de Salud Carlos III, Madrid, España
Locations
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Hospital Unviersitari Son Espases
Palma de Mallorca, Balearic Islands, 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 Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, Canary Islands, 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, Navarre, Spain
Hospital Central de Asturias
Oviedo, Principality of Asturias, 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
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
Countries
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Related Links
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Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group
Other Identifiers
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GEICAM/2017-07
Identifier Type: -
Identifier Source: org_study_id