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

May 1, 2019 updated by: Matthias Mäurer, University of Jena
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

161

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Jena, Germany, 07743
        • Department of Radiooncology, Jena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Primary non-metastatic breast cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
primary non-metastatic breast cancer
Radiation: radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: up to 10 years
from the start of Radiotherapy until death / last seen during follow up
up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: up to 10 years
from the start of Radiotherapy until relapse or metastasis / last seen during follow up
up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2002

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

April 24, 2019

First Submitted That Met QC Criteria

May 1, 2019

First Posted (Actual)

May 2, 2019

Study Record Updates

Last Update Posted (Actual)

May 2, 2019

Last Update Submitted That Met QC Criteria

May 1, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CETC 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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