Tumor Cell, CirculatingCETCNCT04902937
Association of Adjuvant Radiotherapy of Non-metastatic Breast Carcinoma With Immunomodulation and Circulating Tumor Cell Phenotype in Relation to Patient Age.
An observational study of Tumor Cell, Circulating, run by University of Jena at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Tumor Cell, Circulating
- What is being tested?
- Adjuvant radiotherapy and neoadjuvant and adjuvant chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Only female patients with non-metastatic breast carcinoma undergoing breast-conserving surgery (± neoadjuvant or adjuvant system therapy) at the Department of Gynecology and Reproductive Medicine Jena followed by adjuvant radiation therapy at the Department of Radiation Oncology and Radiotherapy Jena between June 1, 2021 and June 1, 2023 (recruitment period) will be studied.
Who may be able to join
- 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
Who cannot join
- DCIS, Inflammatory breast carcinoma
- Recurrence situation
- Presence of distant metastases
- Second malignancies < 10 years prior to diagnosis of breast carcinoma
- Prior exposure to radiotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Radiooncology, Jena
Jena, 07743
Matthias A Mäurer, MD, +4936419328401, matthias.maeurer@med.uni-jena.de
Matthias Mäurer, MD
About this study
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.
Read the detailed description
The primary aim of this prospective-explorative phase 0 study is to investigate the influence of adjuvant radiotherapy in patients with non-metastatic breast cancer on the circulating epithelial tumor cells (CETCs) in the peripheral blood and their immunohistochemical characteristics in younger high risk (premenopausal) versus older low risk (postmenopausal) patients. In addition, the immunophenotype will be determined using peripheral venous blood mononuclear cells (PBMCs) at different time points during the course of therapy and correlated with the results of CETC analysis. The aim of the study is to identify prognostic and predictive biomarkers for early stage breast cancer patients. No therapeutic consequences will be derived.
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
- Tumor Cell, Circulating
- Being tested
- Adjuvant radiotherapy, neoadjuvant and adjuvant chemotherapy
- Keywords
- Early Stage Breast cancer, Circulating Tumor Cells, Tumor-infiltrating lymphocytes, Radiotherapy, Immunophenotyping
- Medical subject headings
- Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant radiotherapyRadiation
Also called breast-conserving therapy
Guideline-based therapy of primary non-metastatic early breast carcinoma
neoadjuvant and adjuvant chemotherapyDrug
Guideline-based therapy of primary non-metastatic early breast carcinoma
| Study group | Role | What they receive |
|---|---|---|
| premenopausal patients | Not described Receives: Radiation: Adjuvant radiotherapy; Drug: neoadjuvant and adjuvant chemotherapy | |
| postmenopausal patients | Not described Receives: Radiation: Adjuvant radiotherapy; Drug: neoadjuvant and adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age-dependent influence of radiotherapy on circulating epithelial tumor cell counts (CETC) and immunophenotype (PBMC).
Measurement of CETC count / µl blood in the course of therapy and correlation with patient age.
Measured: observation period 2 years
Longitudinal quantification of CETCs as well as immunophenotype at specific time points during the course of therapy.
Measurement of CETC count / µl blood in the course of therapy and correlation with the cell count of detected T and B cells / µl blood.
Measured: observation period 2 years
Comparison of immunohistochemical parameters of the primary tumor with the immunohistochemical and cytological parameters of CETC
Comparison of PD-L1 expression of primary tumor cells with CETC in percent. Comparison of hormone receptor status (estrogen, progesterone) values of primary tumor and CETC in percent.
Measured: observation period 2 years
Secondary outcomes (1)
Recurrence-free survival (RFS)
Recurrences as a function of time (analysis using Kaplan-Meier curves, log-rank test, and Cox regression).
Measured: observation period 3 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start1 Jul 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor Cell, CirculatingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Erlangen, Labor Prof. Pachmann
- Responsible party
- Principal investigator, Matthias Mäurer, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902937
- Sponsor's protocol ID
- CETC 002
- Acronym
- CETC
- Status last verified
- Nov 2023
- First submitted
- 19 May 2021
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Adjuvant Radiotherapy of Non-metastatic Breast Carcinoma With Immunomodulation and Circulating Tumor Cell Phenotype in Relation to Patient Age.
- ClinicalTrials.gov ID
- NCT04902937
- Acronym / sponsor ID
- CETC / CETC 002
- Conditions
- Tumor Cell, Circulating
- Keywords
- Early Stage Breast cancer, Circulating Tumor Cells, Tumor-infiltrating lymphocytes, Radiotherapy, Immunophenotyping
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Collaborators
- University Hospital Erlangen, Labor Prof. Pachmann
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary aim of this prospective-explorative phase 0 study is to investigate the influence of adjuvant radiotherapy in patients with non-metastatic breast cancer on the circulating epithelial tumor cells (CETCs) in the peripheral blood and their immunohistochemical characteristics in younger high risk (premenopausal) versus older low risk (postmenopausal) patients. In addition, the immunophenotype will be determined using peripheral venous blood mononuclear cells (PBMCs) at different time points during the course of therapy and correlated with the results of CETC analysis. The aim of the study is to identify prognostic and predictive biomarkers for early stage breast cancer patients. No therapeutic consequences will be derived.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| premenopausal patients | – | Radiation: Adjuvant radiotherapy, Drug: neoadjuvant and adjuvant chemotherapy |
| postmenopausal patients | – | Radiation: Adjuvant radiotherapy, Drug: neoadjuvant and adjuvant chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Only female patients with non-metastatic breast carcinoma undergoing breast-conserving surgery (± neoadjuvant or adjuvant system therapy) at the Department of Gynecology and Reproductive Medicine Jena followed by adjuvant radiation therapy at the Department of Radiation Oncology and Radiotherapy Jena between June 1, 2021 and June 1, 2023 (recruitment period) will be studied.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- DCIS, Inflammatory breast carcinoma
- Recurrence situation
- Presence of distant metastases
- Second malignancies < 10 years prior to diagnosis of breast carcinoma
- Prior exposure to radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjuvant radiotherapyAlso: breast-conserving therapyGuideline-based therapy of primary non-metastatic early breast carcinoma | Radiation | postmenopausal patients, premenopausal patients |
| neoadjuvant and adjuvant chemotherapyGuideline-based therapy of primary non-metastatic early breast carcinoma | Drug | postmenopausal patients, premenopausal patients |
Primary outcome
Age-dependent influence of radiotherapy on circulating epithelial tumor cell counts (CETC) and immunophenotype (PBMC).
Time frame: observation period 2 years
Measurement of CETC count / µl blood in the course of therapy and correlation with patient age.
Longitudinal quantification of CETCs as well as immunophenotype at specific time points during the course of therapy.
Time frame: observation period 2 years
Measurement of CETC count / µl blood in the course of therapy and correlation with the cell count of detected T and B cells / µl blood.
Comparison of immunohistochemical parameters of the primary tumor with the immunohistochemical and cytological parameters of CETC
Time frame: observation period 2 years
Comparison of PD-L1 expression of primary tumor cells with CETC in percent. Comparison of hormone receptor status (estrogen, progesterone) values of primary tumor and CETC in percent.
1 secondary outcome
Recurrence-free survival (RFS)
Time frame: observation period 3 years follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumor Cell, Circulating, run by University of Jena at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age-dependent influence of radiotherapy on circulating epithelial tumor cell counts (CETC) and immunophenotype (PBMC). (time frame: observation period 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.