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Retrospective Observational Study About the Evolution of Patients With Breast Cancer in Hospitals From the GEICAM Group (2002 - 2005). ALAMO IV
This study is currently recruiting participants.
Verified June 2017 by Spanish Breast Cancer Research Group
Sponsor:
Spanish Breast Cancer Research Group
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier:
NCT03210974
First received: June 19, 2017
Last updated: July 5, 2017
Last verified: June 2017
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Purpose
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).
| Condition |
|---|
| Invasive Breast Cancer Between 2002 and 2005 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Retrospective Observational Study About the Evolution of Patients With Breast Cancer in Hospitals From the GEICAM Group (2002 - 2005). ALAMO IV |
Resource links provided by NLM:
Further study details as provided by Spanish Breast Cancer Research Group:
Primary Outcome Measures:
- Study demographic [ Time Frame: 30 months ]Number of participants with the demographic characteristics: Age, sex, race of new cases of breast cancer diagnosed from 2002 to 2005 in Spanish hospitals.
- Study clinical and anatomic-patological [ Time Frame: 30 months ]In the 12.000 patients included to study the clinical and anatomic-patological characteristics: TNM, date of initial diagnosis of BC, biomarkers of new cases of breast cancer diagnosed from 2002 to 2005 in Spanish hospitals
Secondary Outcome Measures:
- Evolution of Breast Cancer [ Time Frame: 30 months ]In the 12.000 patients included to describe the evolution of breast cancer patients in terms of frequency (time).
- Evolution of Breast Cancer [ Time Frame: 30 months ]In the 12.000 patients included to describe the evolution of breast cancer patients in terms of type of relapse.
- Evolution of Breast Cancer [ Time Frame: 30 months ]In the 12.000 patients included to describe the evolution of breast cancer patients in terms of location of relapse.
- Family history of Breast Cancer [ Time Frame: 30 months ]Number of patients with a family history of breast cancer.
- Characteristics of family history of Breast Cancer [ Time Frame: 30 months ]Characteristics clinical-pathological of patients with a family history of breast cancer.
- Differences in Breast Cancer between sex [ Time Frame: 30 months ]Differences cllinical-pathological between men and women with breast cancer
- In the 12.000 patients included to quantify the influence of type of surgery conducted on primary tumor [ Time Frame: 30 months ]
- Number of patients with metastatic disease as first diagnosis [ Time Frame: 30 months ]
- In patients with metastatic disease as first diagnosis to quantify the influence of timepoint of primary tumor surgery [ Time Frame: 30 months ]
| Estimated Enrollment: | 12000 |
| Actual Study Start Date: | June 3, 2016 |
| Estimated Study Completion Date: | December 1, 2018 |
| Estimated Primary Completion Date: | December 1, 2018 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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.
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).
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03210974
Please refer to this study by its ClinicalTrials.gov identifier: NCT03210974
Contacts
| Contact: María Luisa Serrano, Project Manager | 0034 916892870 ext 2003 | lserrano@geicam.org |
Locations
| Spain | |
| Hospital General de Elche | Recruiting |
| Elche, Alicante, Spain | |
| Contact: Álvaro Rodríguez Lescure, MD | |
| Hospital General de Elda | Recruiting |
| Elda, Alicante, Spain | |
| Contact: Cristina Llorca, MD | |
| Hospital Universitario Dentral de Asturias | Recruiting |
| Oviedo, Asturias, Spain | |
| Contact: Yolanda Fernández, MD | |
| Hospital Germans Trias i Pujol | Recruiting |
| Badalona, Barcelona, Spain | |
| Contact: Mireia Margelí, MD | |
| Hospital Municipal de Badalona | Active, not recruiting |
| Badalona, Barcelona, Spain | |
| Hospital Josep Trueta | Recruiting |
| Girona, Barcelona, Spain | |
| Contact: Sonia Del Barco, MD | |
| Hospital General de Granollers | Recruiting |
| Granollers, Barcelona, Spain | |
| Contact: Laura Jolis, MD | |
| Hospital de Mataró-Consorci Sanitari del Maresme | Recruiting |
| Mataró, Barcelona, Spain | |
| Contact: Montserrat Velasco, MD | |
| Corporació Sanitaria Parc Taulí | Recruiting |
| Sabadell, Barcelona, Spain | |
| Contact: Luis Fernández, MD | |
| Consorci Sanitari de Terrasa | Recruiting |
| Terrassa, Barcelona, Spain | |
| Contact: Angels Arcusa, MD | |
| Hospital Universitario Puerta del Mar | Recruiting |
| Cadiz, Cádiz, Spain | |
| Contact: JoséManuel Baena, MD | |
| Onkologikoa | Recruiting |
| San Sebastián, Donostia, Spain | |
| Contact: Arrate Plazaola, MD | |
| Hospital Universitario de Donostia | Recruiting |
| San Sebastián, Donosti, Spain | |
| Contact: Isabel Álvarez, MD | |
| Centro Oncológico de Galicia | Recruiting |
| A Coruña, Galicia, Spain | |
| Contact: Manuel Ramos, MD | |
| Complejo Hospitalario Universitario A Coruña | Recruiting |
| A Coruña, Galicia, Spain | |
| Contact: Lourdes Calvo, MD | |
| Hospital Universitario Lucus Augusti | Recruiting |
| Lugo, Galicia, Spain | |
| Contact: Silvia Varela, MD | |
| Complejo Hospitalario Universitario Ourense | Recruiting |
| Ourense, Galicia, Spain | |
| Contact: Jesús García Mata, MD | |
| Hospital Universitario Dr.Negrín | Recruiting |
| Las Palmas de Gran Canaria, Gran Canaria, Spain | |
| Contact: Marta Mori, MD | |
| Hospital Universitario Fundación Alrcorcón | Recruiting |
| Alcorcón, Madrid, Spain | |
| Contact: Carlos Jara, MD | |
| Hospital Universitario de Fuenlabrada | Recruiting |
| Fuenlabrada, Madrid, Spain | |
| Contact: JuanAntonio Guerra, MD | |
| Hospital Universitario Puerta de Hierro de Majadahonda | Recruiting |
| Majadahonda, Madrid, Spain | |
| Contact: Blanca Cantos, MD | |
| Clínica Universitaria de Navarra | Recruiting |
| Pamplona, Navarra, Spain | |
| Contact: Marta Santisteban, MD | |
| Hospital Universitario Canarias | Recruiting |
| La Laguna, Tenerife, Spain | |
| Contact: Norberto Batista, MD | |
| Hospital Virgen de los Lirios | Recruiting |
| Alcoy, Valencia, Spain | |
| Contact: Amparo Oltra, MD | |
| Hospital Universitario de Basurto | Recruiting |
| Bilbao, Vizcaya, Spain | |
| Contact: Purificación Martínez, MD | |
| Complejo Hospitalario de Albacete | Recruiting |
| Albacete, Spain | |
| Contact: Encarnación Adrover, MD | |
| Hospital General Universitario de Alicante | Recruiting |
| Alicante, Spain | |
| Contact: José Ponce, MD | |
| Hospital Clinic i Provincial de Barcelona | Recruiting |
| Barcelona, Spain | |
| Contact: Montserrat Muñoz, MD | |
| Hospital del Mar-Parc de Salut Mar | Recruiting |
| Barcelona, Spain | |
| Contact: Sonia Servitja, MD | |
| Hospital Virgen de la Luz | Recruiting |
| Cuenca, Spain | |
| Contact: M.Mar Muñoz, MD | |
| Hospital General Universitario Gregorio Marañón | Recruiting |
| Madrid, Spain | |
| Contact: Sara López-Tarruella Cobo, MD | |
| Hospital Universitario La Prinesa | Recruiting |
| Madrid, Spain | |
| Contact: AnaIsabel Ballesteros, MD | |
| H.Clínico Universitario Arrixaca | Recruiting |
| Murcia, Spain | |
| Contact: JoséLuis Alonso, MD | |
| Hospital Universitario Virgen de la Salud | Recruiting |
| Toledo, Spain | |
| Contact: José Ignacio Chacón, MD | |
| Hospital Clínico Universitario de Valencia | Recruiting |
| Valencia, Spain | |
| Contact: Begoña Bermejo, MD | |
| Hospital General de Valencia | Recruiting |
| Valencia, Spain | |
| Contact: Vega Iranzo, MD | |
| Hospital Universitari i Politécnic La Fe | Recruiting |
| Valencia, Spain | |
| Contact: Ana Santaballa, MD | |
| Hospital Universitario Dr. Peset | Recruiting |
| Valencia, Spain | |
| Contact: Rosa María Llorente, MD | |
| Instituto Valenciano de Oncología | Recruiting |
| Valencia, Spain | |
| Contact: Amparo Ruiz, MD | |
| Hospital Clínico Lozano Blesa | Recruiting |
| Zaragoza, Spain | |
| Contact: Raquel Andrés, MD | |
| Hospital Universitario Miguel Servet | Recruiting |
| Zaragoza, Spain | |
| Contact: Antonio Antón, MD | |
| Hospital Nuestra Sra. de Sonsoles | Recruiting |
| Ávila, Spain | |
| Contact: José E. Alés, MD | |
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Instituto de Salud Carlos III
More Information
| Responsible Party: | Spanish Breast Cancer Research Group |
| ClinicalTrials.gov Identifier: | NCT03210974 History of Changes |
| Other Study ID Numbers: |
ÁLAMO IV |
| Study First Received: | June 19, 2017 |
| Last Updated: | July 5, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on July 11, 2017