Spots Global Cancer Trial Database for A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)
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Trial Identification
Brief Title: A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)
Official Title: A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)
Study ID: NCT02819882
Conditions
Interventions
Study Description
Brief Summary: This study is a prospective, multicenter non-interventional cohort study designed to develop a registry in unresectable locally advanced or metastatic disease.
Detailed Description: The target population for inclusion in this study is breast cancer patients recently diagnosed (from January 2016) with unresectable locally advanced or metastatic disease (either after a recurrence or as first diagnosis). 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. Patients enrolled on the study are free to withdraw their informed consent for the use and disclosure of health information at any time and when asked, patients are not obliged to provide a reason. Patients may request discontinuation from the study at any time. The date and the reason for withdrawal or discontinuation from the study must be recorded in the electronic case report form (eCRF). An attempt will be made to determine the date of discontinuation and final status (i. e. withdrawal of consent, loss to follow-up, death) of any patient who discontinues from the study. However, the treating clinician is encouraged to follow the patient as long as possible, until patient death or through study end. The Sponsor has the right to terminate the study at any time. The Sponsor will notify the investigator if the study is placed on hold or if the Sponsor decides to discontinue the study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hospital General de Elche, Elche, Alicante, Spain
Althaia-Xarxa Assistencial de Manresa, Manresa, Barcelona, Spain
Consorci Sanitari de Terrassa, Terrassa, Barcelona, Spain
Hospital Universitario Donostia, San Sebastián, Donostia, Spain
Hospital Dr. Negrín, Las Palmas de Gran Canaria, Gran Canaria, Spain
Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain
Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain
Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain
Hospital Infanta Sofía, San Sebastián de los Reyes, Madrid, Spain
Hospital Son Llatzer, Palma de Mallorca, Mallorca, Spain
Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain
Hospital Universitario de Canarias, Santa Cruz de Tenerife, Tenerife, Spain
Hospital de Sagunto, Sagunto, Valencia, Spain
Hospital Universitario de Basurto, Bilbao, Vizcaya, Spain
Complejo Hospitalario Universitario A Coruña, A Coruña, , Spain
Complejo Hospitalario Universitario de Albacete, Albacete, , Spain
Hospital San Juan de Alicante, Alicante, , Spain
Hospital del Mar, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital Santa Creu i Sant Pau, Barcelona, , Spain
ICO L´Hospitalet, Barcelona, , Spain
Hospital Universitario Germans Trias i Pujol, Barcelona, , Spain
Hospital Moisés Broggi_institut Catalá D´Oncologia, Barcelona, , Spain
Hospital Universitario Reina Sofía, Córdoba, , Spain
Hospital de León, León, , Spain
Hospital Lucus Augusti, Lugo, , Spain
Hospital Universitario La Princesa, Madrid, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, , Spain
Hospital Universitario de Málaga, Málaga, , Spain
Hospital Clínico Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Hospital Virgen de la Salud, Toledo, , Spain
IVO-Instituto Valenciano de Oncología, Valencia, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Hosital General de Valencia, Valencia, , Spain
Hospital Universitario Dr. Peset, Valencia, , Spain
Hospital Clínico Lozano Blesa, Zaragoza, , Spain
Hospital Miguel Servet, Zaragoza, , Spain
Hospital Nuestra Señora de Sonsoles, Ávila, , Spain
Contact Details
Name: Study Director
Affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Role: STUDY_DIRECTOR
Name: Study Director
Affiliation: Hospital de Donostia, San Sebastián, Spain
Role: STUDY_DIRECTOR
Name: Study Director
Affiliation: Hospital Universitario Gregorio Marañón, Madrid, Spain
Role: STUDY_DIRECTOR
Name: Study Director
Affiliation: Instituto Valenciano de Oncología (IVO), Valencia, Spain
Role: STUDY_DIRECTOR
Name: Study Director
Affiliation: Complejo Hospital Universitario A Coruña (CHUAC), Galicia, Spain
Role: STUDY_DIRECTOR
Name: Study Director
Affiliation: Hospital Universitario Fundación Jimenez Díaz, Madrid, Spain
Role: STUDY_DIRECTOR
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