Invasive Breast Cancer Between 2002 and 2005ALAMO-IVNCT03210974
Retrospective Observational Study About Evolution of Patients With Breast Cancer in Hospitals From GEICAM Group
An observational study of Invasive Breast Cancer Between 2002 and 2005, run by Spanish Breast Cancer Research Group at 41 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Breast Cancer Between 2002 and 2005
- How many people
- 13,135 participants
- Where
- 41 sitesSpain
- Study dates
- 3 Jun 2016to 1 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with a single diagnosis of in situ carcinoma (without infiltrating component).
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
Spain41 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Centro Oncológico de Galicia
A Coruña, 15009
Complejo Hospitalario de Albacete
Albacete, 02006
Hospital Universitario Fundación Alrcorcón
Alcorcón, Madrid, 28922
Hospital Virgen de los Lirios
Alcoy, Valencia, 03804
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Nuestra Señora de Sonsoles
Ávila, 05004
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, 08003
Hospital Clinic i Provincial
Barcelona, 08916
Hospital Universitario de Basurto
Bilbao, Vizcaya, 48013
Hospital Universitario Puerta del Mar
Cadiz, 11009
Hospital General Virgen de la Luz
Cuenca, 16002
Onkologikoa
Donostia / San Sebastian, Guipuzcoa, 20014
Hospital Universitario de Donostia
Donostia / San Sebastian, Gupúzcoa, 20014
Hospital General Universitario de Elche
Elche, Alicante, 03203
Hospital General Universitario de Elda - Virgen de la Salud
Elda, Alicante, 03600
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942
Hospital Josep Trueta
Girona, 17007
Hospital General de Granollers
Granollers, Barcelona, 08400
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Las Palmas, 35010
Hospital Universitario Lucus Augusti
Lugo, 27003
Hospital Universitario La Prinesa
Madrid, 28006
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, Madrid, 28222
Hospital de Mataró-Consorci Sanitari del Maresme
Mataró, Barcelona, 08304
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120
Complejo Hospitalario Universitario de Ourense
Ourense, 32005
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Clínica Universidad de Navarra
Pamplona, Navarre, 31008
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, 08208
Hospital Universitario Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227
Hospital Universitario Virgen de la Salud
Toledo, 45071
Instituto Valenciano de Oncología
Valencia, 46006
Hospital Clínico Universitario de Valencia
Valencia, 46010
Hospital General Universitario de Valencia
Valencia, 46014
Hospital Universitario Dr. Peset
Valencia, 46017
Hospital Universitari i Politécnic La Fe
Valencia, 46026
Hospital Clínico Universitario de Zaragoza Lozano Blesa
Zaragoza, 50009
Hospital Universitario Miguel Servet
Zaragoza, 50009
About this study
Official title: Retrospective Observational Study About the Evolution of Patients With Breast Cancer in Hospitals From the GEICAM Group (2002 - 2005). ALAMO IV
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).
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 months
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
Measured: 30 months
Secondary outcomes (9)
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).
Measured: 30 months
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.
Measured: 30 months
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.
Measured: 30 months
Family history of Breast Cancer
Number of patients with a family history of breast cancer.
Measured: 30 months
Characteristics of family history of Breast Cancer
Characteristics clinical-pathological of patients with a family history of breast cancer.
Measured: 30 months
Differences in Breast Cancer between sex
Differences clinical-pathological between men and women with breast cancer
Measured: 30 months
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
Measured: 30 months
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
Measured: 30 months
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
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start3 Jun 2016
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive Breast Cancer Between 2002 and 2005Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13,135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Breast Cancer Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Hospital Universitario Fundación AlcorcónStudy Director, Study director, Hospital General Universitario Gregorio MarañonStudy Director, Study director, Instituto de Salud Carlos III de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210974
- Sponsor's protocol ID
- ÁLAMO IV
- Acronym
- ALAMO-IV
- Status last verified
- Mar 2023
- First submitted
- 19 Jun 2017
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31882586
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observational Study About the Evolution of Patients With Breast Cancer in Hospitals From the GEICAM Group (2002 - 2005). ALAMO IV
- ClinicalTrials.gov ID
- NCT03210974
- Acronym / sponsor ID
- ALAMO-IV / ÁLAMO IV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,135 participants (actual)
- Lead sponsor
- Spanish Breast Cancer Research GroupUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 3 Jun 2016 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with a single diagnosis of in situ carcinoma (without infiltrating component).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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-pathological
Time frame: 30 months
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
9 secondary outcomes
Evolution of Breast Cancer in terms of frequency
Time frame: 30 months
Evolution of Breast Cancer in terms of type
Time frame: 30 months
Evolution of Breast Cancer in terms of location of relapse
Time frame: 30 months
Family history of Breast Cancer
Time frame: 30 months
Characteristics of family history of Breast Cancer
Time frame: 30 months
Differences in Breast Cancer between sex
Time frame: 30 months
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
Quantify the prevalence of breast cancer related to pregnancy
Time frame: 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Results publication: PubMed 31882586Lopez-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.
- Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research GroupLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Hospital Universitario Fundación Alcorcón
Study Director study director
Hospital General Universitario Gregorio Marañon
Study Director study director
Instituto de Salud Carlos III de Madrid
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Breast Cancer Between 2002 and 2005, run by Spanish Breast Cancer Research Group at 41 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study demographic (time frame: 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03210974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.