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Long-Term Follow-up Study of Early Stage Breast Cancer Patients Included in GEICAM Studies

NCT ID: NCT03390894

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

8000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-18

Study Completion Date

2048-01-31

Brief Summary

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This is a multicenter, cohorts study to collect information from patients diagnosed with early-stage invasive breast cancer who have been previously included in a neoadjuvant or adjuvant clinical trial of the GEICAM group.

Patients will be included in this study from the moment of completion of the follow-up of the studies of origin and will be followed for approximately 30 years

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Detailed Description

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One consequence of the improvement in survival rates of certain tumors such as breast cancer is the increase in the number of patients available for long-term follow-up in randomized controlled clinical trials. This long follow-up allows an additional long-term evaluation of the efficacy, as well as of the sequelae related to the treatments that may occur beyond the time of the primary analysis.

The target population of the study are all patients who were included in neoadjuvant and adjuvant clinical trials of GEICAM performed by the goup since 1998 in the medical oncology units of the participating sites, ensuring a follow-up of patients of approximately 30 years. This will allow to describe the long-term evolution of the patients with invasive breast cancer in early stages.

The information obtained will be very useful to professionals involved in the diagnosis, treatment and monitoring of breast cancer, hospital managers, patients with this condition and society in general. This study provides data of great interest for the estimation of long-term disease requirements.

Conditions

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Invasive Breast Cancer Early Stages

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients included in neoadjuvant and adjuvant clinical trials with GEICAM's participation. If any of these patients had taken part or is participating in another clinical trial, she/he is eligible for this trial and her/his information will also be collected.
* Patients whose death or contact loss has not been previously collected in the databases of the original studies.

Exclusion Criteria

* Patient who were not included in the analyses of the original studies due to non-compliance of the eligibility criteria or the original study informed consent withdrawal.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AECC_Asociación Española contra el Cáncer

UNKNOWN

Sponsor Role collaborator

Spanish Breast Cancer Research Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Complejo Hospitalario de Especialidades Virgen de la Victoria

Study Director

Role: STUDY_DIRECTOR

Hospital General Universitario Gregorio Marañón

Locations

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Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Site Status NOT_YET_RECRUITING

Hospital San Agustín Avilés

Avilés, Principality of Asturias, Spain

Site Status RECRUITING

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, Spain

Site Status NOT_YET_RECRUITING

Centro Oncológico de Galicia

A Coruña, , Spain

Site Status RECRUITING

Complejo Hospitalario A Coruña

A Coruña, , Spain

Site Status RECRUITING

Complejo Hospitalario Universitario de Albacete

Albacete, , Spain

Site Status RECRUITING

Hospital General Universitario de Alicante

Alicante, , Spain

Site Status RECRUITING

Hospital General Universitario de Elche

Alicante, , Spain

Site Status RECRUITING

Hospital General Universitario de Elda

Alicante, , Spain

Site Status RECRUITING

Hospital Virgen De Los Lirios

Alicante, , Spain

Site Status RECRUITING

Hospital Infanta Cristina

Badajoz, , Spain

Site Status RECRUITING

Hospital Universitari Germans Trias i Pujol

Badalona, , Spain

Site Status RECRUITING

Consorci Sanitari de Terrassa

Barcelona, , Spain

Site Status RECRUITING

Hospital Clinic i Provincial

Barcelona, , Spain

Site Status RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Hospital del Mar

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario Mutua Terrassa

Barcelona, , Spain

Site Status RECRUITING

Instituto Catalán Oncología Barcelona Hospital Duran I Reynalds

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario de Basurto

Bilbao, , Spain

Site Status RECRUITING

Hospital Universitario de Burgos

Burgos, , Spain

Site Status RECRUITING

Complejo Especialidades de Jerez de la Frontera

Cadiz, , Spain

Site Status RECRUITING

Hospital Universitario Puerta del Mar

Cadiz, , Spain

Site Status RECRUITING

Complejo Hospitalario de Castellón

Castelló, , Spain

Site Status RECRUITING

Hospital Universitario Reina Sofía

Córdoba, , Spain

Site Status RECRUITING

Hospital Virgen De La Luz

Cuenca, , Spain

Site Status RECRUITING

Hospital Universitario de Cruces

Donostia / San Sebastian, , Spain

Site Status RECRUITING

Hospital Universitario Donostia

Donostia / San Sebastian, , Spain

Site Status RECRUITING

Onkologikoa

Donostia / San Sebastian, , Spain

Site Status RECRUITING

Instituto Catalán de Oncología Gerona Hospital Dr. Josep Trueta

Girona, , Spain

Site Status RECRUITING

Hospital Universitario San Cecilio

Granada, , Spain

Site Status RECRUITING

Hospital Universitario Virgen De Las Nieves

Granada, , Spain

Site Status RECRUITING

Hospital Universitario de Guadalajara

Guadalajara, , Spain

Site Status RECRUITING

Complejo Hospitalario de Especialidades Juan Ramón Jiménez

Huelva, , Spain

Site Status RECRUITING

Complejo Hospitalario de Jaén

Jaén, , Spain

Site Status RECRUITING

Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín

Las Palmas de Gran Canaria, , Spain

Site Status NOT_YET_RECRUITING

Hospital de León

León, , Spain

Site Status RECRUITING

Hospital Universitario Lucus Augusti

Lugo, , Spain

Site Status RECRUITING

Hopsital Clínico San Carlos

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital de Mostoles

Madrid, , Spain

Site Status RECRUITING

Hospital general Universitario Gregorio Marañón

Madrid, , Spain

Site Status RECRUITING

Hospital Madrid Montepricipe

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Fuenlabrada

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Fundación Alcorcón

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario La Paz

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario La Princesa

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Severo Ochoa

Madrid, , Spain

Site Status RECRUITING

MD Anderson Cancer Center

Madrid, , Spain

Site Status NOT_YET_RECRUITING

ALTHAIA Xarxa Asistencial Universitària Manresa

Manresa, , Spain

Site Status RECRUITING

Hospital Regional de Málaga Carlos Haya

Málaga, , Spain

Site Status RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Site Status RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, , Spain

Site Status RECRUITING

Hospital General Universitario José María Morales Meseguer

Murcia, , Spain

Site Status RECRUITING

Hospital santa María Naí

Ourense, , Spain

Site Status RECRUITING

Complejo Hospitalario de Palencia

Palencia, , Spain

Site Status NOT_YET_RECRUITING

Hospital Álvaro Cunqueiro

Pontevedra, , Spain

Site Status RECRUITING

Corporación Sanitaria Parc Taulí

Sabadell, , Spain

Site Status RECRUITING

Hospital Universitario de Salamanca

Salamanca, , Spain

Site Status RECRUITING

Hospital Nuestra Señora De La Candelaria

Santa Cruz de Tenerife, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario de Valme

Seville, , Spain

Site Status RECRUITING

Hospital Universitario Sant Joan De Reus

Tarragona, , Spain

Site Status RECRUITING

Hospital Virgen de la Salud

Toledo, , Spain

Site Status RECRUITING

Fundación Instituto Valenciano de Oncología

Valencia, , Spain

Site Status RECRUITING

Hospital Arnau Vilanova

Valencia, , Spain

Site Status RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Site Status RECRUITING

Hospital de Sagunto

Valencia, , Spain

Site Status RECRUITING

Hospital General Universitario de Valencia

Valencia, , Spain

Site Status RECRUITING

Hospital Universitari i Politécnic La Fe

Valencia, , Spain

Site Status RECRUITING

Hospital Universitario Dr. Peset Aleixandre

Valencia, , Spain

Site Status RECRUITING

Hospital de Txagorritxu

Vitoria-Gasteiz, , Spain

Site Status RECRUITING

Hospital Clínico Universitario de Zaragoza Lozano Blesa

Zaragoza, , Spain

Site Status RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Study Project Manager

Role: CONTACT

[email protected]
00346592870

Start-Up Unit Manager

Role: CONTACT

[email protected]
00346592870

Related Links

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http://www.geicam.org

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

Other Identifiers

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2017-002850-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GEICAM/2016-03

Identifier Type: -

Identifier Source: org_study_id

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