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
N/A
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
Researchers are studying the effects of adjuvant radiotherapy on patients with non-metastatic breast cancer, focusing on circulating epithelial tumor cells (CETCs) in the blood and their immunohistochemical features. The study compares younger high-risk (premenopausal) and older low-risk (postmenopausal) patients to explore how age influences these cells and immune system markers. The goal is to find potential prognostic biomarkers by analyzing molecular and immune changes during treatment. The study involves patients receiving guideline-based adjuvant radiotherapy after tumor removal, with some also having neoadjuvant or adjuvant chemotherapy. Blood samples are collected at multiple time points during therapy to detect, isolate, and genetically characterize CETCs. Immunophenotyping of peripheral blood mononuclear cells is performed, and tumor tissue is analyzed for immunohistochemical features and tumor-infiltrating lymphocytes. The study also examines therapy-resistant tumor cell phenotypes through in vitro cultivation. Participants will have blood drawn and tissue samples analyzed to track changes in CETCs and immune markers over two years. The study evaluates the relationship between these markers and tumor characteristics, with follow-up monitoring for recurrence-free survival over three years. This research aims to better understand molecular and immune responses to radiotherapy without altering the patients' treatment plans.
CONDITIONS
Brief 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)
- Breast-conserving therapy planned with or without neoadjuvant or adjuvant systemic therapy plus subsequent adjuvant radiotherapy of the breast and lymphatic drainage
- Female patients providing 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
- History of other malignancies within 10 years prior to breast cancer diagnosis
- Previous exposure to radiotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of chemotherapy and radiotherapy as per clinical guidelines
Participants receive guideline-based therapy including neoadjuvant and adjuvant chemotherapy and adjuvant radiotherapy for non-metastatic breast cancer.
Visits occur at specific time points during the course of therapy for blood sampling and observation
Duration - Up to 3 years follow-up
Participants are observed for changes in circulating tumor cells and immunophenotype as well as recurrence-free survival over the follow-up period.
Periodic follow-up visits for up to 3 years
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
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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