Investigating the effects of radiotherapy on circulating tumor cells in breast cancer patients
Official title: Association of Adjuvant Radiotherapy of Non-metastatic Breast Carcinoma With Immunomodulation and Circulating Tumor Cell Phenotype in Relation to Patient Age.
Run by University of Jena · NCT04902937 · Data updated 2026-11-12
This study is testing how radiation treatment affects certain cancer cells in the blood of younger and older women with early-stage breast cancer to help improve future treatment plans.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | University of Jena Academic / other |
| Locations | 1 site (Jena) |
| Status | Recruiting |
| Started | July 1, 2021 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | November 28, 2023 |
| Trial ID | NCT04902937 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with histologically confirmed invasive breast carcinoma who are undergoing curative-intended breast-conserving therapy followed by adjuvant radiotherapy.
✕Probably not a fit
Patients with ductal carcinoma in situ (DCIS), inflammatory breast carcinoma, or those with distant metastases will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore how adjuvant radiotherapy affects circulating epithelial tumor cells (CETCs) in patients with non-metastatic breast carcinoma, focusing on differences based on patient age. Blood samples will be collected at various time points after tumor resection and during radiotherapy to analyze the immunohistochemical characteristics of CETCs and their correlation with tumor-infiltrating lymphocytes. The study seeks to identify prognostic and predictive biomarkers that could inform treatment strategies for early-stage breast cancer patients.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of tumor biology and better personalized treatment strategies for breast cancer patients.
How similar studies have gone: While similar studies have explored the relationship between radiotherapy and circulating tumor cells, this specific approach focusing on age-related differences in immunomodulation is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Department of Radiooncology, Jena
Jena, Germany Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using a 3D culture model to study circulating tumor cells in head and neck cancer
This study is trying to see how circulating tumor cells from patients with head and neck cancer behave in a lab setting to better understand how the cancer spreads and comes back.
-
Enrich circulating tumor cells in metastatic prostate cancer by leukapheresis vs blood sampling
This observational study tests whether leukapheresis can enrich circulating tumor cells more effectively than standard blood draws in men with metastatic prostate cancer.
-
Comparing chemotherapy and observation for liver metastasis in colorectal cancer
This study is testing if some patients with liver metastasis from colorectal cancer can safely skip chemotherapy after surgery and just be monitored instead.
-
Maintenance therapy for colorectal cancer patients after liver surgery
This study is testing if adding maintenance therapy to standard chemotherapy can help colorectal cancer patients with liver metastases live longer without their cancer getting worse after surgery.
-
Evaluating circulating tumor cells in breast cancer after treatment and surgery
This study is testing if collecting and analyzing certain cancer cells from the blood of women with breast cancer after treatment and surgery can help predict their future health outcomes.
-
Liquid biopsy to detect AXL-positive circulating tumor cells in pancreatic cancer
This test tries a blood-based liquid biopsy to see if AXL-positive circulating tumor cells can be found in adults with newly diagnosed metastatic pancreatic cancer who have not yet received treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.