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Association of Adjuvant Radiotherapy of Non-metastatic Breast Carcinoma With Immunomodulation and Circulating Tumor Cell Phenotype in Relation to Patient Age.

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Observational
SUMMARY

In a prospective study, the influence of adjuvant radiotherapy in patients with non-metastatic breast carcinoma on the epithelial tumor cells (CETCs) circulating in the blood and their immunohistochemical characteristics depending on age will be investigated. In addition to a histopathological assignment of the CETCs as cells of the primary tumor, major trigger points of the immune system will be exploratively analyzed. For this purpose, blood samples are taken from the patients at different time points after tumor resection and during adjuvant radiotherapy. In addition to the detection, isolation and genetic characterization of the CETCs, the determination of immunological biomarkers by immunophenotyping, among other methods, is planned. Furthermore, analyses of tissue from the primary tumor with respect to immunohistochemical features as well as tumor-infiltrating lymphocytes (TILs) are planned. The results will be classified and correlated especially with regard to patient age. As there are insufficient data available for breast carcinoma regarding radiotherapeutic effects on the immune system depending on patient age, it is of great interest to better understand these molecular biological basics in order to identify potential prognostic biomarkers.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
View:

• Primary diagnosis histologically confirmed invasive breast carcinoma pT1-4 pN0 or pN+ cM0

• curative-intended breast-conserving therapy (BET) ± (neo-) adj. system therapy with subsequent adjuvant radiotherapy of the breast ± lymphatic drainage system planned

• informed consent of the patient

Locations
Other Locations
Germany
Department of Radiooncology, Jena
RECRUITING
Jena
Time Frame
Start Date: 2021-07-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 200
Treatments
premenopausal patients
postmenopausal patients
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital Erlangen, Labor Prof. Pachmann
Leads: University of Jena

This content was sourced from clinicaltrials.gov