Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648148
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-01-30
Brief Title:
Molecular Biomarkers of Response to Radiation Therapy in Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Molecular Biomarkers of Response to Radiation Therapy in Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to identify potential genetic and other molecular biomarkers of response to radiation therapy in breast cancer that may help to personalize breast cancer radiation treatment in the future
Detailed Description:
Monocentric prospective clinical study including DCIS patients treated at the Institute of Oncology Ljubljana Patients treated with adjuvant radiotherapy and without systemic therapy are eligible for the study
Adverse events of radiation treatment will be assessed after radiotherapy and during 5-year follow up and classified according to Common Terminology Criteria for Adverse Events v50
Molecular biomarkers will be assessed before radiotherapy after radiotherapy and during follow up DNA will be isolated from whole blood samples obtained before radiation treatment Circulating biomarkers will be isolated from plasma samples before treatment after treatment and during follow-up Written informed consent will be obtained from all included patients and the study design was approved by the National Medical Ethics Committee
Adverse events of radiation treatment will be assessed after radiotherapy and during 5-year follow up and classified according to Common Terminology Criteria for Adverse Events v50
Molecular biomarkers will be assessed before radiotherapy after radiotherapy and during follow up DNA will be isolated from whole blood samples obtained before radiation treatment Circulating biomarkers will be isolated from plasma samples before treatment after treatment and during follow-up Written informed consent will be obtained from all included patients and the study design was approved by the National Medical Ethics Committee
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None