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

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03935802
• Other study ID #: CETC 001
• Status: Completed
• Start date: September 1, 2002
• Est. completion date: September 1, 2018

Study information

• Verified date: April 2019
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Radiation:
• radiation

Locations

Country	Name	City	State
Germany	Department of Radiooncology, Jena	Jena

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	from the start of Radiotherapy until death / last seen during follow up	up to 10 years
Secondary	Disease free survival	from the start of Radiotherapy until relapse or metastasis / last seen during follow up	up to 10 years