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Completed

NCT Number: NCT03935802

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

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.

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Key information

Conditions

Breast Cancer Female Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Radiooncology, Jena

Jena, 07743, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiation

Radiation

Primary outcomes

  1. Overall survival

    Time frame: up to 10 years

    from the start of Radiotherapy until death / last seen during follow up

Secondary outcomes

  1. Disease free survival

    Time frame: up to 10 years

    from the start of Radiotherapy until relapse or metastasis / last seen during follow up

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Important dates

Study start
2002
Primary completion
2012
Study completion
2018
First posted
May 2, 2019
Registry last updated
May 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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