Invasive Breast Cancer Between 2002 and 2005 Clinical Trial
— ALAMO-IVOfficial title:
Retrospective Observational Study About the Evolution of Patients With Breast Cancer in Hospitals From the GEICAM Group (2002 - 2005). ALAMO IV
| NCT number | NCT03210974 |
| Other study ID # | ÁLAMO IV |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 3, 2016 |
| Est. completion date | March 1, 2021 |
| Verified date | March 2023 |
| Source | Spanish Breast Cancer Research Group |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 13135 |
| Est. completion date | March 1, 2021 |
| Est. primary completion date | March 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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). |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Centro Oncológico de Galicia | A Coruña | |
| Spain | Complejo Hospitalario Universitario A Coruña | A Coruña | |
| Spain | Complejo Hospitalario de Albacete | Albacete | |
| Spain | Hospital Universitario Fundación Alrcorcón | Alcorcón | Madrid |
| Spain | Hospital Virgen de los Lirios | Alcoy | Valencia |
| Spain | Hospital General Universitario de Alicante | Alicante | |
| Spain | Hospital Nuestra Señora de Sonsoles | Ávila | |
| Spain | Hospital Universitario Germans Trias i Pujol | Badalona | Barcelona |
| Spain | Hospital Clinic i Provincial | Barcelona | |
| Spain | Hospital del Mar | Barcelona | |
| Spain | Hospital Universitario de Basurto | Bilbao | Vizcaya |
| Spain | Hospital Universitario Puerta del Mar | Cadiz | |
| Spain | Hospital General Virgen de la Luz | Cuenca | |
| Spain | Hospital Universitario de Donostia | Donostia-San Sebastián | Gupúzcoa |
| Spain | Onkologikoa | Donostia-San Sebastián | Guipuzcoa |
| Spain | Hospital General Universitario de Elche | Elche | Alicante |
| Spain | Hospital General Universitario de Elda - Virgen de la Salud | Elda | Alicante |
| Spain | Hospital Universitario de Fuenlabrada | Fuenlabrada | Madrid |
| Spain | Hospital Josep Trueta | Girona | |
| Spain | Hospital General de Granollers | Granollers | Barcelona |
| Spain | Hospital Universitario Canarias | La Laguna | Santa Cruz De Tenerife |
| Spain | Hospital Universitario de Gran Canaria Doctor Negrín | Las Palmas de Gran Canaria | Las Palmas |
| Spain | Hospital Universitario Lucus Augusti | Lugo | |
| Spain | Hospital General Universitario Gregorio Marañón | Madrid | |
| Spain | Hospital Universitario La Prinesa | Madrid | |
| Spain | Hospital Universitario Puerta de Hierro de Majadahonda | Majadahonda | Madrid |
| Spain | Hospital de Mataró-Consorci Sanitari del Maresme | Mataró | Barcelona |
| Spain | Hospital Clínico Universitario Virgen de la Arrixaca | Murcia | |
| Spain | Complejo Hospitalario Universitario de Ourense | Ourense | |
| Spain | Hospital Universitario Central de Asturias | Oviedo | Asturias |
| Spain | Clínica Universidad de Navarra | Pamplona | Navarra |
| Spain | Corporació Sanitaria Parc Taulí | Sabadell | Barcelona |
| Spain | Consorci Sanitari de Terrassa | Terrassa | Barcelona |
| Spain | Hospital Universitario Virgen de la Salud | Toledo | |
| Spain | Hospital Clínico Universitario de Valencia | Valencia | |
| Spain | Hospital General Universitario de Valencia | Valencia | |
| Spain | Hospital Universitari i Politécnic La Fe | Valencia | |
| Spain | Hospital Universitario Dr. Peset | Valencia | |
| Spain | Instituto Valenciano de Oncología | Valencia | |
| Spain | Hospital Clínico Universitario de Zaragoza Lozano Blesa | Zaragoza | |
| Spain | Hospital Universitario Miguel Servet | Zaragoza |
| Lead Sponsor | Collaborator |
|---|---|
| Spanish Breast Cancer Research Group | Instituto de Salud Carlos III |
Spain,
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, Car — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Study demographic | Number of participants with the demographic characteristics: Age, sex, race of new cases of breast cancer diagnosed from 2002 to 2005 in Spanish hospitals. | 30 months | |
| Primary | Study clinical and anatomic-pathological | In the 12.000 patients included to study the clinical and anatomic-pathological characteristics: primary tumor, regional nodes, metastasis status (TNM), date of initial diagnosis of Breast Cancer (BC), biomarkers of new cases of breast cancer diagnosed from 2002 to 2005 in Spanish hospitals | 30 months | |
| Secondary | Evolution of Breast Cancer in terms of frequency | In the 12.000 patients included to describe the evolution of breast cancer patients in terms of frequency (time). | 30 months | |
| Secondary | Evolution of Breast Cancer in terms of type | In the 12.000 patients included to describe the evolution of breast cancer patients in terms of type of relapse. | 30 months | |
| Secondary | Evolution of Breast Cancer in terms of location of relapse | In the 12.000 patients included to describe the evolution of breast cancer patients in terms of location of relapse. | 30 months | |
| Secondary | Family history of Breast Cancer | Number of patients with a family history of breast cancer. | 30 months | |
| Secondary | Characteristics of family history of Breast Cancer | Characteristics clinical-pathological of patients with a family history of breast cancer. | 30 months | |
| Secondary | Differences in Breast Cancer between sex | Differences clinical-pathological between men and women with breast cancer | 30 months | |
| Secondary | Quantify the influence of type of surgery conducted on primary tumor | In the 12.000 patients included to quantify the influence of type of surgery conducted on primary tumor | 30 months | |
| Secondary | Number of patients with metastatic disease as first diagnosis | In the 12.000 patients included to quantify the influence of timepoint of primary tumor surgery in patients with metastatic disease as first diagnosis | 30 months | |
| Secondary | Quantify the prevalence of breast cancer related to pregnancy | In the 12.000 patients included to quantify the prevalence of breast cancer related to pregnancy | 30 months |