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OpenTrials
Completed

NCT Number: NCT02439554

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Galdakao-Usansolo

Galdakao, Bizkaia, 48960, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Mortality data

    Time frame: Mortality at 2 years

Sponsors and collaborators

Lead sponsor

Hospital Galdakao-Usansolo

Other Gov

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 8, 2015
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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