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出境医 / 临床实验 / Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy

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

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 Intervention/treatment
Breast Cancer Female Radiation: radiation

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
Layout table for study information
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 1, 2002
Actual Primary Completion Date : September 1, 2012
Actual Study Completion Date : September 1, 2018
Arms and Interventions
Group/Cohort 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
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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

Locations
Layout table for location information
Germany
Department of Radiooncology, Jena
Jena, Germany, 07743
Sponsors and Collaborators
University of Jena
Tracking Information
First Submitted Date April 24, 2019
First Posted Date May 2, 2019
Last Update Posted Date May 2, 2019
Actual Study Start Date September 1, 2002
Actual Primary Completion Date September 1, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 1, 2019) 		Overall survival [ Time Frame: up to 10 years ]
from the start of Radiotherapy until death / last seen during follow up
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 1, 2019) 		Disease free survival [ Time Frame: up to 10 years ]
from the start of Radiotherapy until relapse or metastasis / last seen during follow up
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy
Official Title Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary non-metastatic breast cancer
Condition Breast Cancer Female
Intervention Radiation: radiation
Study Groups/Cohorts primary non-metastatic breast cancer
primary non-metastatic breast cancer
Intervention: Radiation: radiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 1, 2019) 		161
Original Actual Enrollment Same as current
Actual Study Completion Date September 1, 2018
Actual Primary Completion Date September 1, 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03935802
Other Study ID Numbers CETC 001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Matthias Mäurer, University of Jena
Study Sponsor University of Jena
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Jena
Verification Date April 2019

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