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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.

Recruitingn/aAges 18 Years - anyFemaleUniversity of Jena
NCT04902937 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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) a

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * DCIS, Inflammatory breast carcinoma * Recurrence situation * Presence of distant metastases * Second malignancies \< 10 years prior to diagnosis of breast carcinoma * Prior exposure to radiotherapy
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What it tests

  • Adjuvant radiotherapy
  • neoadjuvant and adjuvant chemotherapy
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Where

1 site
Department of Radiooncology, Jena
Jena, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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