Clinical trial NCT03210974: Retrospective Observational Study About Evolution of Patients With Breast Cancer in Hospitals From GEICAM Group
Official title: Retrospective Observational Study About the Evolution of Patients With Breast Cancer in Hospitals From the GEICAM Group (2002 - 2005). ALAMO IV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Breast Cancer Between 2002 and 2005
Lead sponsor: Spanish Breast Cancer Research Group
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2017-07-07
Enrollment: 13135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study target population are all patients (men and women) who have been newly diagnosed with invasive breast cancer between January 1, 2002 and December 31, 2005 and treated in the medical oncology departments of participating sites, ensuring an approximate follow-up of 10 years.

Brief summary: This study is a non-interventional (NIS), multicenter, retrospective cohort study, which will obtain data from patients diagnosed with invasive breast cancer between 2002 and 2005 in the medical oncology departments of hospitals that are members of GEICAM (using information obtained from patient medical histories).

Detailed description: There is no specific treatment regimen for this study. This is an observational retrospective study in which the clinical decisions concerning the optimal strategy in the treatment of the disease for each patient have been taken independently and prior to the physician's decision to include patient data in this registry, in keeping with the drug information, local treatment guidelines and/or standard clinical practice.

The study target population are all patients (men and women) who have been newly diagnosed with invasive breast cancer between January 1, 2002 and December 31, 2005 and treated in the medical oncology departments of participating sites, ensuring an approximate follow-up of 10 years.

Eligibility criteria: Inclusion Criteria:

* Patients whose first primary breast invasive tumor diagnosis occurred between January 1, 2002 and December 31, 2005 and who have received treatment in the medical oncology departments of participating sites.
* Patients who were diagnosed at the participating site; otherwise the site where the initial diagnosis was made should be contacted with in order to confirm that the patient has not already been enrolled in the study or pending inclusion. The objective is to avoid duplicate records for displaced patients.

Exclusion Criteria:

* Patients with a single diagnosis of in situ carcinoma (without infiltrating component).

Primary outcomes:
measure: Study demographic
timeFrame: 30 months
measure: Study clinical and anatomic-pathological
timeFrame: 30 months
Secondary outcomes:
measure: Evolution of Breast Cancer in terms of frequency
timeFrame: 30 months
measure: Evolution of Breast Cancer in terms of type
timeFrame: 30 months
measure: Evolution of Breast Cancer in terms of location of relapse
timeFrame: 30 months
measure: Family history of Breast Cancer
timeFrame: 30 months
measure: Characteristics of family history of Breast Cancer
timeFrame: 30 months
measure: Differences in Breast Cancer between sex
timeFrame: 30 months
measure: Quantify the influence of type of surgery conducted on primary tumor
timeFrame: 30 months
measure: Number of patients with metastatic disease as first diagnosis
timeFrame: 30 months
measure: Quantify the prevalence of breast cancer related to pregnancy
timeFrame: 30 months
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Elda
country: Spain
facility: Hospital General Universitario de Elda - Virgen de la Salud
state: Alicante
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: Granollers
country: Spain
facility: Hospital General de Granollers
state: Barcelona
city: Mataró
country: Spain
facility: Hospital de Mataró-Consorci Sanitari del Maresme
state: Barcelona
city: Sabadell
country: Spain
facility: Corporació Sanitaria Parc Taulí
state: Barcelona
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
city: Donostia-San Sebastián
country: Spain
facility: Onkologikoa
state: Guipuzcoa
city: Donostia-San Sebastián
country: Spain
facility: Hospital Universitario de Donostia
state: Gupúzcoa
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
state: Las Palmas
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alrcorcón
state: Madrid
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro de Majadahonda
state: Madrid
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
state: Navarra
city: La Laguna
country: Spain
facility: Hospital Universitario Canarias
state: Santa Cruz De Tenerife
city: Alcoy
country: Spain
facility: Hospital Virgen de los Lirios
state: Valencia
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto
state: Vizcaya
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: A Coruña
country: Spain
facility: Centro Oncológico de Galicia
city: Albacete
country: Spain
facility: Complejo Hospitalario de Albacete
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Cuenca
country: Spain
facility: Hospital General Virgen de la Luz
city: Girona
country: Spain
facility: Hospital Josep Trueta
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Universitario La Prinesa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
city: Ourense
country: Spain
facility: Complejo Hospitalario Universitario de Ourense
city: Toledo
country: Spain
facility: Hospital Universitario Virgen de la Salud
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
city: Valencia
country: Spain
facility: Hospital Universitari i Politécnic La Fe
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario de Zaragoza Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Ávila
country: Spain
facility: Hospital Nuestra Señora de Sonsoles
Study officials:
affiliation: Hospital Universitario Fundación Alcorcón
name: Study Director
role: STUDY_DIRECTOR
affiliation: Hospital General Universitario Gregorio Marañón
name: Study Director
role: STUDY_DIRECTOR
affiliation: Instituto de Salud Carlos III de Madrid
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Lopez-Tarruella S, Escudero MJ, Pollan M, Martin M, Jara C, Bermejo B, Guerrero-Zotano A, Garcia-Saenz J, Santaballa A, Alba E, Andres R, Martinez P, Calvo L, Fernandez A, Batista N, Llombart-Cussac A, Anton A, Lahuerta A, de la Haba J, Lopez-Vega JM, Carrasco E. Survival impact of primary tumor resection in de novo metastatic breast cancer patients (GEICAM/El Alamo Registry). Sci Rep. 2019 Dec 27;9(1):20081. doi: 10.1038/s41598-019-55765-9.