Optimization of Radiation Protection Through Genomic Analyses (ORtogether)
September 25, 2024 updated by: Maja Guberina, University Hospital, Essen
Optimization of Radiation Protection Through Genomic Analyses in the Analysis of Changes in Cells of the Hematopoietic System Before and During High Dose External Beam Radiotherapy
The long-term goal is to define "signatures" in the form of genomic changes through sequence analyses of genomic DNA using modern Next Generation Sequencing (NGS) methods, which
- determine the radiation exposure of humans.
- provide information about the exposure (dose).
- determine the radiation quality.
- predict the repair capacity and radiation resistance of an individual.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
The planned research work will investigate structural changes in DNA caused by loosely ionizing and high-LET (Linear Energy Transfer) radiation as well as their attribution to double-strand break repair pathways, which will be analysed in parallel using modern microscopy methods.
Our aim is to incorporate sequencing technologies into the spectrum of methods used in radiation research and radiation protection.
It is important for us to consider the practical requirements of radiation protection and to extend our experimental approaches to cell types relevant to radiation protection.
For this reason, we have now created a separate work program that will focus specifically on sequence analyses in irradiated human lymphocytes.
The aim is to successfully transfer the experimental approaches and bioinformatic analyses established in previous experiments in human skin fibroblasts to lymphocytes.
Subjects can donate blood samples on a voluntary basis at predetermined times.
Only subjects without previous radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc. and without a previous tumor diagnosis in the medical history and in good performance status (ECOG 0-1) will be included.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Germany / NRW
-
Essen, Germany / NRW, Germany, 45147
- Recruiting
- Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West
-
Contact:
- Maja Guberina, PD Dr. med. (MD), specialist
- Phone Number: +492017232321
- Email: maja.guberina@uk-essen.de
-
Contact:
- Ina Grübel
-
Principal Investigator:
- Maja Guberina, PD Dr. med. (MD)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
ECOG 0/1 no prior treatment no prior cancer diagnosis thoracic or head and neck cancer
Exclusion Criteria:
prior treatment (chemotherapy, radiotherapy, etc.) prior cancer diagnosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interventional Arm
|
Alteration of the genome under radiotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alteration of the genome under radiotherapy
Time Frame: 5 years
|
Radiotherapy of patients, quantitative tissue sampling, cell culture survival rate and mitotic index after predifined radiation treatment, Incidence of the sample and percentage
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression Free Survival
Time Frame: 5 years
|
Progression Free Survival
|
5 years
|
|
Overall Survival
Time Frame: 5 years
|
Overall Survival
|
5 years
|
|
Radiation induced changes in the genome
Time Frame: 2 months to 5 years
|
Radiation induced changes in the genome analyzing human skin fibroblasts and lymphocytes: translocations that permitted cell division andm mismatch repair of radiation-induced DNA damage (PCR and M-FISH), Incidence of the sample and percentage |
2 months to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2024
Primary Completion (Estimated)
December 15, 2025
Study Completion (Estimated)
January 15, 2030
Study Registration Dates
First Submitted
December 30, 2023
First Submitted That Met QC Criteria
February 7, 2024
First Posted (Actual)
February 12, 2024
Study Record Updates
Last Update Posted (Actual)
September 27, 2024
Last Update Submitted That Met QC Criteria
September 25, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 23-11672-BO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.