NCT03935802

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 2, 2019

Completed
Last Updated

May 2, 2019

Status Verified

April 1, 2019

Enrollment Period

10 years

First QC Date

April 24, 2019

Last Update Submit

May 1, 2019

Conditions

Breast Cancer Female

Keywords

RadiotherapyCETCCTCbreast cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    from the start of Radiotherapy until death / last seen during follow up

    up to 10 years

Secondary Outcomes (1)

  • Disease free survival

    up to 10 years

Study Arms (1)

primary non-metastatic breast cancer

primary non-metastatic breast cancer

Radiation: radiation

Interventions

radiationRADIATION
primary non-metastatic breast cancer

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary non-metastatic breast cancer

You may qualify if:

  • 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)

You may not qualify if:

  • presence of metastases
  • recurrence
  • DCIS, inflammatory breast cancer
  • second malignancy \<10 years before diagnosis of breast cancer
  • radiotherapeutic pretreatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiooncology, Jena

Jena, 07743, Germany

Location

Related Publications (1)

  • 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.

    PMID: 36661670DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Matthias Mäurer

Study Record Dates

First Submitted

April 24, 2019

First Posted

May 2, 2019

Study Start

September 1, 2002

Primary Completion

September 1, 2012

Study Completion

September 1, 2018

Last Updated

May 2, 2019

Record last verified: 2019-04

Locations

DE(1)