Actively Recruiting
Association of Adjuvant Radiotherapy of Non-metastatic Breast Carcinoma With Immunomodulation and Circulating Tumor Cell Phenotype in Relation to Patient Age.
Led by University of Jena · Updated on 2023-11-28
200
Participants Needed
1
Research Sites
287 weeks
Total Duration
On this page
Sponsors
U
University of Jena
Lead Sponsor
U
University Hospital Erlangen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Association of Adjuvant Radiotherapy of Non-metastatic Breast Carcinoma With Immunomodulation and Circulating Tumor Cell Phenotype in Relation to Patient Age.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary diagnosis of invasive breast carcinoma confirmed by histology (pT1-4 pN0 or pN+ cM0)
- Planned curative breast-conserving therapy with or without (neo-)adjuvant systemic therapy and subsequent adjuvant radiotherapy of the breast and possibly lymphatic drainage system
- Patient provides informed consent
You will not qualify if you...
- Diagnosis of ductal carcinoma in situ (DCIS) or inflammatory breast carcinoma
- Recurrence of breast cancer
- Presence of distant metastases
- Second cancers diagnosed within 10 years before breast cancer diagnosis
- Previous exposure to radiotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Radiooncology, Jena
Jena, Germany, 07743
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here