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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03935802

Recruitment Status Completed

First Posted May 2, 2019

Last update posted May 2, 2019

Study Description

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.

  • Condition or Disease:Breast Cancer Female
  • Intervention/Treatment: Radiation: radiation
  • Phase: N/A
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 Design
  • Study Type: Observational
  • Actual Enrollment: 161 participants
  • Observational Model: Cohort
  • Time Perspective: Retrospective
  • Official Title: Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy
  • Actual Study Start Date: September 2002
  • Actual Primary Completion Date: September 2012
  • Actual Study Completion Date: September 2018
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: primary non-metastatic breast cancer
primary non-metastatic breast cancer
Radiation: radiation
Outcome Measures
  • Primary Outcome Measures: 1. Overall survival [ Time Frame: up to 10 years ]
    from the start of Radiotherapy until death / last seen during follow up
  • Secondary Outcome Measures: 1. Disease free survival [ Time Frame: up to 10 years ]
    from the start of Radiotherapy until relapse or metastasis / last seen during follow up
Eligibility Criteria
  • Ages Eligible for Study: 18 to 99 Years (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Primary non-metastatic breast cancer
Criteria

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

Contacts and Locations
Contacts
Locations

Germany
Department of Radiooncology, Jena
Jena

Sponsors and Collaborators

University of Jena

More Information
  • Responsible Party: University of Jena
  • ClinicalTrials.gov Identifier: NCT03935802 History of Changes
  • Other Study ID Numbers: CETC 001
  • First Posted: May 2, 2019 Key Record Dates
  • Last Update Posted: May 2, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University of Jena: CTC
    Radiotherapy
    CETC
    breast cancer
  • Additional relevant MeSH terms: Breast Neoplasms