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Risk Factors for Medium-term Adverse Outcomes and Predictive Modeling for Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02439554
Recruitment Status : Completed
First Posted : May 8, 2015
Last Update Posted : March 26, 2019
Information provided by (Responsible Party):
Susana García Gutiérrez, Hospital Galdakao-Usansolo

Brief Summary:
This subproject is included in a project coordinated between program groups Evaluation of Health Services of Epidemiology and Public Health (Project CAMISS). The overall objective is to evaluate different aspects of health care received by patients with breast cancer from the diagnostic process, treatment, complications, survival and quality of life, to provide information to improve the effectiveness of interventions, reduce variability, have best predictive rules and increase the quality of life. The main objective of the subproject is to create and validate prospectively predictive rules of recurrence, complications, mortality, changes in quality of life in these patients at admission and one/two years of treatment and to evaluate the external validity of our rules to predict relapses, complications and mortality in the retrospective sample of patients participating in screening programs. Observational methodology with information available from a retrospective cohort of women diagnosed between 2000 and 2009 and another 2-year prospective follow-up included 2040 incident cases of breast cancer in 18 hospitals of 5 regions. Cohorts will learn clinical and health care diagnosis, tumor, treatment, hospital, follow-up (complications, relapse, and vital status) cost and quality of life. Prediction rules are created by means of regression/Cox models at the prospective sample and also investigators will assess the external validity in the retrospective cohort in the case of recurrence, complications and mortality. Expected results: There are currently no results of cohort analysis of the diagnostic process of care that integrates different aspects. The study will create tools to assist prognostic and therapeutic decision making process in these patients

Condition or disease
Breast Cancer

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1463 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Risk Factors for Medium-term Adverse Outcomes and Predictive Modeling for Breast Cancer Patients
Actual Study Start Date : April 2013
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Change in quality of life questionnaire module for breast cancer patients [ Time Frame: Change from baseline in quality of life at 2 years ]

Secondary Outcome Measures :
  1. Mortality data [ Time Frame: Mortality at 2 years ]

Information from the National Library of Medicine

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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:   Probability Sample
Study Population
Patients diagnosed with both in situ and infiltrating breast cancer

Inclusion Criteria:

  • Women over the age of 18 with both incidental in situ and infiltrating breast cancer.

Exclusion Criteria:

  • Lymphoma, sarcoma, lobular carcinoma in situ and inflammatory carcinoma of the breast are excluded

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 identifier (NCT number): NCT02439554

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Hospital Galdakao-Usansolo
Galdakao, Bizkaia, Spain, 48960
Sponsors and Collaborators
Hospital Galdakao-Usansolo
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Principal Investigator: Susana GArcía, PhD, MD Hospital Galdakao-Usansolo
Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Susana García Gutiérrez, PhD, Md, Hospital Galdakao-Usansolo Identifier: NCT02439554    
Other Study ID Numbers: PI12/01842
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases