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

NCT02439554 | Completed DMC

• 1 other identifier: PI12/01842
• Study Type: observational
• Target: 1,463
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in quality of life questionnaire module for breast cancer patients

  Change from baseline in quality of life at 2 years

Secondary Outcomes (1)

• Mortality data

  Mortality at 2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with both in situ and infiltrating breast cancer

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Galdakao-Usansolo: lead

Study Sites (1)

Hospital Galdakao-Usansolo

Galdakao, Bizkaia, 48960, Spain

Location

Related Publications (1)

• 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.

  PMID: 29310641 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Susana GArcía, PhD, MD

  Hospital Galdakao-Usansolo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Md

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: May 8, 2015
• Study Start: April 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: March 26, 2019

Record last verified: 2019-03

Locations

ES (1)