Retrospective Observational Study About Evolution of Patients With Breast Cancer in Hospitals From GEICAM Group

Completed

• Conditions: Invasive Breast Cancer Between 2002 and 2005

• Registration Number: NCT03210974
• Lead Sponsor: Spanish Breast Cancer Research Group

Brief Summary

This study is a non-interventional (NIS), multicenter, retrospective cohort study, which will obtain data from patients diagnosed with invasive breast cancer between 2002 and 2005 in the medical oncology departments of hospitals that are members of GEICAM (using information obtained from patient medical histories).

Detailed Description

There is no specific treatment regimen for this study. This is an observational retrospective study in which the clinical decisions concerning the optimal strategy in the treatment of the disease for each patient have been taken independently and prior to the physician's decision to include patient data in this registry, in keeping with the drug information, local treatment guidelines and/or standard clinical practice.

The study target population are all patients (men and women) who have been newly diagnosed with invasive breast cancer between January 1, 2002 and December 31, 2005 and treated in the medical oncology departments of participating sites, ensuring an approximate follow-up of 10 years.

Study Timeline

• Study Start: 2016-06-03
• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-07-05
• Study First Posted: 2017-07-07
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-03
• Last Update Posted: 2023-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13135

Inclusion Criteria

• Patients whose first primary breast invasive tumor diagnosis occurred between January 1, 2002 and December 31, 2005 and who have received treatment in the medical oncology departments of participating sites.
• Patients who were diagnosed at the participating site; otherwise the site where the initial diagnosis was made should be contacted with in order to confirm that the patient has not already been enrolled in the study or pending inclusion. The objective is to avoid duplicate records for displaced patients.

Exclusion Criteria

• Patients with a single diagnosis of in situ carcinoma (without infiltrating component).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study clinical and anatomic-pathological	30 months	In the 12.000 patients included to study the clinical and anatomic-pathological characteristics: primary tumor, regional nodes, metastasis status (TNM), date of initial diagnosis of Breast Cancer (BC), biomarkers of new cases of breast cancer diagnosed from 2002 to 2005 in Spanish hospitals
Study demographic	30 months	Number of participants with the demographic characteristics: Age, sex, race of new cases of breast cancer diagnosed from 2002 to 2005 in Spanish hospitals.

Secondary Outcome Measures

Name	Time	Method
Evolution of Breast Cancer in terms of frequency	30 months	In the 12.000 patients included to describe the evolution of breast cancer patients in terms of frequency (time).
Evolution of Breast Cancer in terms of location of relapse	30 months	In the 12.000 patients included to describe the evolution of breast cancer patients in terms of location of relapse.
Characteristics of family history of Breast Cancer	30 months	Characteristics clinical-pathological of patients with a family history of breast cancer.
Quantify the prevalence of breast cancer related to pregnancy	30 months	In the 12.000 patients included to quantify the prevalence of breast cancer related to pregnancy
Evolution of Breast Cancer in terms of type	30 months	In the 12.000 patients included to describe the evolution of breast cancer patients in terms of type of relapse.
Differences in Breast Cancer between sex	30 months	Differences clinical-pathological between men and women with breast cancer
Quantify the influence of type of surgery conducted on primary tumor	30 months	In the 12.000 patients included to quantify the influence of type of surgery conducted on primary tumor
Number of patients with metastatic disease as first diagnosis	30 months	In the 12.000 patients included to quantify the influence of timepoint of primary tumor surgery in patients with metastatic disease as first diagnosis
Family history of Breast Cancer	30 months	Number of patients with a family history of breast cancer.

Trial Locations

Locations (41)

Hospital General Universitario de Elche; 🇪🇸 Elche, Alicante, Spain

Hospital General Universitario de Elda - Virgen de la Salud; 🇪🇸 Elda, Alicante, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Hospital Universitario Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital General de Granollers; 🇪🇸 Granollers, Barcelona, Spain

Hospital de Mataró-Consorci Sanitari del Maresme; 🇪🇸 Mataró, Barcelona, Spain

Corporació Sanitaria Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain

Consorci Sanitari de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Onkologikoa; 🇪🇸 Donostia-San Sebastián, Guipuzcoa, Spain

Hospital Universitario de Donostia; 🇪🇸 Donostia-San Sebastián, Gupúzcoa, Spain

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