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

NCT ID: NCT02439554

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1463 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2017-06-30

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

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Galdakao-Usansolo

OTHER_GOV

Sponsor Role: lead

Responsible Party

Susana García Gutiérrez

PhD, Md

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susana GArcía, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Galdakao-Usansolo

Locations

Hospital Galdakao-Usansolo

Galdakao, Bizkaia, Spain

Countries

Spain

References

Garcia-Gutierrez S, Orive M, Sarasqueta C, Legarreta MJ, Gonzalez N, Redondo M, Rivero A, Serrano-Aguilar P, Castells X, Quintana JM, Sala M; REDISSEC-CaMISS group. Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective study. BMC Cancer. 2018 Jan 8;18(1):54. doi: 10.1186/s12885-017-3926-9.

Reference Type: DERIVED

PMID: 29310641 (View on PubMed)

Other Identifiers

PI12/01842

Identifier Type: -

Identifier Source: org_study_id