NCT04902937 Association of Adjuvant Radiotherapy of Non-metastatic Breast Carcinoma With Immunomodulation and Circulating Tumor Cell Phenotype in Relation to Patient Age.
| NCT ID | NCT04902937 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Jena |
| Condition | Tumor Cell, Circulating |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-07-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2021-07-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Frequently Asked Questions
Who can join the NCT04902937 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Tumor Cell, Circulating. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04902937 currently recruiting?
Yes, NCT04902937 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Jena to inquire about joining.
Where is the NCT04902937 trial being conducted?
This trial is being conducted at Jena, Germany.
Who is sponsoring the NCT04902937 clinical trial?
NCT04902937 is sponsored by University of Jena. The trial plans to enroll 200 participants.