Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy

Completed

• Conditions: Breast Cancer Female
• Interventions: Radiation: radiation

• Registration Number: NCT03935802
• Lead Sponsor: University of Jena

Brief Summary

The aim of this study was to investigate the systemic effect of radiotherapy on patients with primary non-metastatic breast cancer using CETC and to analyze possible changes in CETC quantity under adjuvant radiotherapy.

Detailed Description

In cooperation with the Women's Hospital of the Friedrich Schiller University in Jena, a total of 161 patients with clinically proven, primarily non-metastatic breast cancer were sampled and examined before and after radiotherapy over a period from 09/2002 to 09/2012. The MAINTRAC method was used to quantitatively determine the amount of CETC in the blood and to observe its peritherapeutic course.

Study Timeline

• Study Start: 2002-09-01
• Primary Completion: 2012-09-01
• Study Completion: 2018-09-01
• Status Verified: 2019-04
• Study First Submitted: 2019-04-24
• Study First Submitted QC: 2019-05-01
• Last Update Submitted: 2019-05-01
• Study First Posted: 2019-05-02
• Last Update Posted: 2019-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 161

Inclusion Criteria

• histologically confirmed invasive breast carcinoma
• age >= 18 years
• exclusive treatment at the Jena University Hospital
• complete curative-intended adjuvant or definite radiotherapy
• at least 2 blood collections (before the start of therapy, after the end of the RT)

Exclusion Criteria

• presence of metastases
• recurrence
• DCIS, inflammatory breast cancer
• second malignancy <10 years before diagnosis of breast cancer
• radiotherapeutic pretreatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
primary non-metastatic breast cancer	radiation	primary non-metastatic breast cancer

Primary Outcome Measures

Name	Time	Method
Overall survival	up to 10 years	from the start of Radiotherapy until death / last seen during follow up

Secondary Outcome Measures

Name	Time	Method
Disease free survival	up to 10 years	from the start of Radiotherapy until relapse or metastasis / last seen during follow up

Trial Locations

Locations (1)

Department of Radiooncology, Jena; 🇩🇪 Jena, Germany