Retrospective Observational Study About Evolution of Patients With Breast Cancer in Hospitals From GEICAM Group

NCT ID: NCT03210974

Last Updated: 2023-03-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 13135 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-03
• Study Completion Date: 2021-03-01

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.

Conditions

Invasive Breast Cancer Between 2002 and 2005

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Spanish Breast Cancer Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Hospital Universitario Fundación Alcorcón

Study Director

Role: STUDY_DIRECTOR

Hospital General Universitario Gregorio Marañón

Study Director

Role: STUDY_DIRECTOR

Instituto de Salud Carlos III de Madrid

Locations

Hospital General Universitario de Elche

Elche, Alicante, Spain

Hospital General Universitario de Elda - Virgen de la Salud

Elda, Alicante, Spain

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital General de Granollers

Granollers, Barcelona, Spain

Hospital de Mataró-Consorci Sanitari del Maresme

Mataró, Barcelona, Spain

Corporació Sanitaria Parc Taulí

Sabadell, Barcelona, Spain

Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

Onkologikoa

Donostia / San Sebastian, Guipuzcoa, Spain

Hospital Universitario de Donostia

Donostia / San Sebastian, Gupúzcoa, Spain

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital Universitario Fundación Alrcorcón

Alcorcón, Madrid, Spain

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, Spain

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, Madrid, Spain

Clínica Universidad de Navarra

Pamplona, Navarre, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital Universitario Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

Hospital Virgen de los Lirios

Alcoy, Valencia, Spain

Hospital Universitario de Basurto

Bilbao, Vizcaya, Spain

Complejo Hospitalario Universitario A Coruña

A Coruña, , Spain

Centro Oncológico de Galicia

A Coruña, , Spain

Complejo Hospitalario de Albacete

Albacete, , Spain

Hospital General Universitario de Alicante

Alicante, , Spain

Hospital Nuestra Señora de Sonsoles

Ávila, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Clinic i Provincial

Barcelona, , Spain

Hospital Universitario Puerta del Mar

Cadiz, , Spain

Hospital General Virgen de la Luz

Cuenca, , Spain

Hospital Josep Trueta

Girona, , Spain

Hospital Universitario Lucus Augusti

Lugo, , Spain

Hospital Universitario La Prinesa

Madrid, , Spain

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, , Spain

Complejo Hospitalario Universitario de Ourense

Ourense, , Spain

Hospital Universitario Virgen de la Salud

Toledo, , Spain

Instituto Valenciano de Oncología

Valencia, , Spain

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Hospital General Universitario de Valencia

Valencia, , Spain

Hospital Universitario Dr. Peset

Valencia, , Spain

Hospital Universitari i Politécnic La Fe

Valencia, , Spain

Hospital Clínico Universitario de Zaragoza Lozano Blesa

Zaragoza, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Countries

Spain

References

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.

Reference Type: RESULT

PMID: 31882586 (View on PubMed)

Related Links

http://www.geicam.org

Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group

Other Identifiers

ÁLAMO IV

Identifier Type: -

Identifier Source: org_study_id