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Long-Term Follow-up Study

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ClinicalTrials.gov Identifier: NCT03390894
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
AECC_Asociación Española contra el Cáncer
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

Brief Summary:

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


Condition or disease
Invasive Breast Cancer Early Stages

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 8000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Long-Term Follow-up Study of Early Stage Breast Cancer Patients Included in GEICAM Studies
Actual Study Start Date : January 18, 2018
Estimated Primary Completion Date : January 2047
Estimated Study Completion Date : January 2048

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  1. Event Free Survival (EvFS) in neoadjuvant studies. [ Time Frame: Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately. ]

    The EvFS, is defined as the time from the randomization of the patients in the studies of origin, to the date of one of the following events:

    • Disease progression during neoadjuvant treatment.
    • Disease relapse (local, regional or distant) after curative surgery.
    • Second primary tumors
    • Death due to any cause.

  2. Disease Free Survival (DFS) in adjuvant studies. [ Time Frame: Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately. ]

    DFS is defined as the time from the date of randomization of patients in the studies of origin, to the date of one of the following events:

    • Disease relapse (local, regional or distant) after curative surgery.
    • Second primary tumors
    • Death due to any cause.


Secondary Outcome Measures :
  1. Overall Survival (OS). [ Time Frame: Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately. ]
    Overall Survival (OS) defined as the time from the date of study enrolment to the date of death from any cause.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with invasive breast cancer (early stages) included in neoadjuvant and adjuvant clinical trials with GEICAM's participation.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390894


Contacts
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Contact: Study Project Manager 00346592870 inicio_ensayos@geicam.org
Contact: Start-Up Unit Manager 00346592870 inicio_ensayos@geicam.org

Locations
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Spain
Hospital Universitario de Canarias Not yet recruiting
La Laguna, Tenerife, Spain
Centro Oncológico de Galicia Not yet recruiting
A Coruña, Spain
Complejo Hospitalario A Coruña Not yet recruiting
A Coruña, Spain
Hospital Universitari Germans Trias i Pujol Not yet recruiting
Badalona, Spain
Hospital Clinic i Provincial Not yet recruiting
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau Not yet recruiting
Barcelona, Spain
Hospital del Mar Not yet recruiting
Barcelona, Spain
Hospital Universitario Reina Sofía Not yet recruiting
Córdoba, Spain
Onkologikoa Not yet recruiting
Donostia, Spain
Complejo Hospitalario de Jaén Not yet recruiting
Jaén, Spain
ALTHAIA Xarxa Asistencial Universitària Manresa Not yet recruiting
Manresa, Spain
Hospital Universitario Virgen de la Victoria Recruiting
Málaga, Spain
Corporación Sanitaria Parc Taulí Not yet recruiting
Sabadell, Spain
Hospital Virgen de la Salud Not yet recruiting
Toledo, Spain
Hospital Clínico Universitario de Valencia Not yet recruiting
Valencia, Spain
Hospital Universitari i Politécnic La Fe Not yet recruiting
Valencia, Spain
Sponsors and Collaborators
Spanish Breast Cancer Research Group
AECC_Asociación Española contra el Cáncer
Investigators
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Study Director: Study Director Complejo Hospitalario de Especialidades Virgen de la Victoria
Study Director: Study Director Hospital General Universitario Gregorio Marañón

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Responsible Party: Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT03390894     History of Changes
Other Study ID Numbers: GEICAM/2016-03
2017-002850-35 ( EudraCT Number )
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Spanish Breast Cancer Research Group:
Long-term Follow-Up
Invasive Breast Cancer Early Stages
Previous Neoadjuvant treatment
Previous Adjuvant treatment

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases