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

NCT02439554 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1463

Last updated 2019-03-26

No results posted yet for this study

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

Conditions

Sponsors & Collaborators

  • Hospital Galdakao-Usansolo

    lead OTHER_GOV

Principal Investigators

  • Susana GArcía, PhD, MD · Hospital Galdakao-Usansolo

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02439554 on ClinicalTrials.gov