Association of Adjuvant Radiotherapy of Non-metastatic Breast Carcinoma With Immunomodulation and Circulating Tumor Cell Phenotype in Relation to Patient Age.
NCT ID: NCT04902937
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
200 participants
OBSERVATIONAL
2021-07-01
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
For this purpose, the phenotype and molecular biological profile of CETC will be investigated and compared with the corresponding characteristics of the primary tumor in order to assign the tumor cells detected in the peripheral blood to the primary tumor. In this context, the number of tumor-infiltrating lymphocytes (TILs) will be correlated with circulating tumor cells and immunophenotype.
Another goal is the characterization of individually isolated CETC by RT-PCR. The expression of selected marker genes involved in metastatic processes will be investigated during the course of therapy and compared with that of the primary tumor to identify therapy-associated changes. The in vitro cultivation of so-called tumor spheres and their characterization as a sign of a therapy-resistant phenotype is a secondary objective of the study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
premenopausal patients
Adjuvant radiotherapy
Guideline-based therapy of primary non-metastatic early breast carcinoma
neoadjuvant and adjuvant chemotherapy
Guideline-based therapy of primary non-metastatic early breast carcinoma
postmenopausal patients
Adjuvant radiotherapy
Guideline-based therapy of primary non-metastatic early breast carcinoma
neoadjuvant and adjuvant chemotherapy
Guideline-based therapy of primary non-metastatic early breast carcinoma
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Adjuvant radiotherapy
Guideline-based therapy of primary non-metastatic early breast carcinoma
neoadjuvant and adjuvant chemotherapy
Guideline-based therapy of primary non-metastatic early breast carcinoma
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Recurrence situation
* Presence of distant metastases
* Second malignancies \< 10 years prior to diagnosis of breast carcinoma
* Prior exposure to radiotherapy
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital Erlangen
OTHER
Labor Prof. Pachmann
UNKNOWN
University of Jena
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Matthias Mäurer
Dr. med.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Radiooncology, Jena
Jena, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CETC 002
Identifier Type: -
Identifier Source: org_study_id