Breast Cancer FemaleNCT03935802
Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy
An observational study of Breast Cancer Female, run by University of Jena at 1 site in Germany.
Trial summary
The aim of this study was to investigate the systemic effect of radiotherapy on patients with primary non-metastatic breast cancer using CETC and to analyze possible changes in CETC quantity under adjuvant radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- radiation
- Type of treatment
- Surgery or procedure
- How many people
- 161 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2002to 1 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Primary non-metastatic breast cancer
Who may be able to join
- histologically confirmed invasive breast carcinoma
- age >= 18 years
- exclusive treatment at the Jena University Hospital
- complete curative-intended adjuvant or definite radiotherapy
- at least 2 blood collections (before the start of therapy, after the end of the RT)
Who cannot join
- presence of metastases
- recurrence
- DCIS, inflammatory breast cancer
- second malignancy <10 years before diagnosis of breast cancer
- radiotherapeutic pretreatment
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to investigate the systemic effect of radiotherapy on patients with primary non-metastatic breast cancer using CETC and to analyze possible changes in CETC quantity under adjuvant radiotherapy.
Read the detailed description
In cooperation with the Women's Hospital of the Friedrich Schiller University in Jena, a total of 161 patients with clinically proven, primarily non-metastatic breast cancer were sampled and examined before and after radiotherapy over a period from 09/2002 to 09/2012. The MAINTRAC method was used to quantitatively determine the amount of CETC in the blood and to observe its peritherapeutic course.
- Conditions
- Breast Cancer Female
- Being tested
- radiation
- Keywords
- Radiotherapy, CETC, CTC, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiationRadiation
| Study group | Role | What they receive |
|---|---|---|
| primary non-metastatic breast cancer | primary non-metastatic breast cancer Receives: Radiation: radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
from the start of Radiotherapy until death / last seen during follow up
Measured: up to 10 years
Secondary outcomes (1)
Disease free survival
from the start of Radiotherapy until relapse or metastasis / last seen during follow up
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start1 Sep 2002
- Primary completion1 Sep 2012
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies 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
- Retrospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Mäurer, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935802
- Sponsor's protocol ID
- CETC 001
- Status last verified
- Apr 2019
- First submitted
- 24 Apr 2019
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Maurer M, Schott D, Pizon M, Drozdz S, Wendt T, Wittig A, Pachmann K. Increased Circulating Epithelial Tumor Cells (CETC/CTC) over the Course of Adjuvant Radiotherapy Is a Predictor of Less Favorable Outcome in Patients with Early-Stage Breast Cancer. Curr Oncol. 2022 Dec 24;30(1):261-273. doi: 10.3390/curroncol30010021.
PubMed 36661670
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy
- ClinicalTrials.gov ID
- NCT03935802
- Acronym / sponsor ID
- CETC 001
- Conditions
- Breast Cancer Female
- Keywords
- Radiotherapy, CETC, CTC, breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- 1 Sep 2002 (actual)
- Primary completion
- 1 Sep 2012 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 2 May 2019 (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.
The aim of this study was to investigate the systemic effect of radiotherapy on patients with primary non-metastatic breast cancer using CETC and to analyze possible changes in CETC quantity under adjuvant radiotherapy.
Detailed description
In cooperation with the Women's Hospital of the Friedrich Schiller University in Jena, a total of 161 patients with clinically proven, primarily non-metastatic breast cancer were sampled and examined before and after radiotherapy over a period from 09/2002 to 09/2012. The MAINTRAC method was used to quantitatively determine the amount of CETC in the blood and to observe its peritherapeutic course.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| primary non-metastatic breast cancer | – | Radiation: radiationprimary non-metastatic breast cancer |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary non-metastatic breast cancer
Key inclusion criteria (5 listed)
- histologically confirmed invasive breast carcinoma
- age >= 18 years
- exclusive treatment at the Jena University Hospital
- complete curative-intended adjuvant or definite radiotherapy
- at least 2 blood collections (before the start of therapy, after the end of the RT)
Key exclusion criteria (5 listed)
- presence of metastases
- recurrence
- DCIS, inflammatory breast cancer
- second malignancy <10 years before diagnosis of breast cancer
- radiotherapeutic pretreatment
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 |
|---|---|---|
| radiation | Radiation | primary non-metastatic breast cancer |
Primary outcome
Overall survival
Time frame: up to 10 years
from the start of Radiotherapy until death / last seen during follow up
1 secondary outcome
Disease free survival
Time frame: up to 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Derived from this study: PubMed 36661670Maurer M, Schott D, Pizon M, Drozdz S, Wendt T, Wittig A, Pachmann K. Increased Circulating Epithelial Tumor Cells (CETC/CTC) over the Course of Adjuvant Radiotherapy Is a Predictor of Less Favorable Outcome in Patients with Early-Stage Breast Cancer. Curr Oncol. 2022 Dec 24;30(1):261-273. doi: 10.3390/curroncol30010021.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Breast Cancer Female, 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 5 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: finished, as of the sponsor's last update on 2 May 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03935802, which also lists 1 linked publication.
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 2 May 2019.