Analysis of Circulating Epithelial Tumor Cells in Periphe... | NCT03935802

Studies
Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy

NCT03935802

Sponsor

University of Jena

Status

Completed

Last Update Posted

May 2, 2019Actual

Enrollment

161Actual

Phase

Not provided

Conditions

Breast Cancer Female

Interventions

radiation

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2002Actual

Primary Completion Date

Sep 1, 2012Actual

Completion Date

Sep 1, 2018Actual

First Submitted Date

Apr 24, 2019

First Submission Date that Met QC Criteria

May 1, 2019

First Posted Date

May 2, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2019

Last Update Posted Date

May 2, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

161Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
primary non-metastatic breast cancer		primary non-metastatic breast cancer	Radiation: radiation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
radiation	Radiation		primary non-metastatic breast cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	from the start of Radiotherapy until death / last seen during follow up	up to 10 years

Secondary Outcomes

Measure	Description	Time Frame
Disease free survival	from the start of Radiotherapy until relapse or metastasis / last seen during follow up	up to 10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Primary non-metastatic breast cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Radiooncology, Jena		Jena		07743	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36661670	Derived	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.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases