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出境医 / 临床实验 / Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy
Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy
Study Description
Brief 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Breast Cancer Female | Radiation: radiation |
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
| Study Type : | Observational |
| Actual Enrollment : | 161 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy |
| Actual Study Start Date : | September 1, 2002 |
| Actual Primary Completion Date : | September 1, 2012 |
| Actual Study Completion Date : | September 1, 2018 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
primary non-metastatic breast cancer
primary non-metastatic breast cancer
|
Radiation: radiation |
Outcome Measures
Primary Outcome Measures :
- Overall survival [ Time Frame: up to 10 years ]from the start of Radiotherapy until death / last seen during follow up
Secondary Outcome Measures :
- Disease free survival [ Time Frame: up to 10 years ]from the start of Radiotherapy until relapse or metastasis / last seen during follow up
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Primary non-metastatic breast cancer
Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- presence of metastases
- recurrence
- DCIS, inflammatory breast cancer
- second malignancy <10 years before diagnosis of breast cancer
- radiotherapeutic pretreatment
Contacts and Locations
Locations
| Germany | |
| Department of Radiooncology, Jena | |
| Jena, Germany, 07743 | |
Sponsors and Collaborators
University of Jena
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 24, 2019 | ||||
| First Posted Date | May 2, 2019 | ||||
| Last Update Posted Date | May 2, 2019 | ||||
| Actual Study Start Date | September 1, 2002 | ||||
| Actual Primary Completion Date | September 1, 2012 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Overall survival [ Time Frame: up to 10 years ] from the start of Radiotherapy until death / last seen during follow up
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
Disease free survival [ Time Frame: up to 10 years ] from the start of Radiotherapy until relapse or metastasis / last seen during follow up
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy | ||||
| Official Title | Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy | ||||
| Brief 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. | ||||
| 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 Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Primary non-metastatic breast cancer | ||||
| Condition | Breast Cancer Female | ||||
| Intervention | Radiation: radiation | ||||
| Study Groups/Cohorts | primary non-metastatic breast cancer
primary non-metastatic breast cancer
Intervention: Radiation: radiation
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
161 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | September 1, 2018 | ||||
| Actual Primary Completion Date | September 1, 2012 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender |
|
||||
| Ages | 18 Years to 99 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Germany | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03935802 | ||||
| Other Study ID Numbers | CETC 001 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement |
|
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| Responsible Party | Matthias Mäurer, University of Jena | ||||
| Study Sponsor | University of Jena | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | University of Jena | ||||
| Verification Date | April 2019 | ||||
