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

NCT ID: NCT03935802

Last Updated: 2019-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

161 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-09-01

Study Completion Date

2018-09-01

Brief Summary

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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

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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.

Conditions

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Breast Cancer Female

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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primary non-metastatic breast cancer

primary non-metastatic breast cancer

radiation

Intervention Type RADIATION

Interventions

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radiation

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Jena

OTHER

Sponsor Role lead

Responsible Party

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Matthias Mäurer

Dr. Matthias Mäurer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Radiooncology, Jena

Jena, , Germany

Site Status

Countries

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Germany

References

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Maurer M, Schott D, Pizon M, Drozdz S, Wendt T, Wittig A, Pachmann K. Increased Circulating Epithelial Tumor Cells (CETC/CTC) over the Course of Adjuvant Radiotherapy Is a Predictor of Less Favorable Outcome in Patients with Early-Stage Breast Cancer. Curr Oncol. 2022 Dec 24;30(1):261-273. doi: 10.3390/curroncol30010021.

Reference Type DERIVED
PMID: 36661670 (View on PubMed)

Other Identifiers

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CETC 001

Identifier Type: -

Identifier Source: org_study_id

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