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Trial Title:
Optimization of Radiation Protection Through Genomic Analyses
NCT ID:
NCT06253338
Condition:
DNA
Cancer
Radiation
Conditions: Keywords:
DNA
cancer
sequencing technologies
lymphocyte
genomic
loosely ionizing radiation
Linear Energy Transfer
outcome
thoracic radiotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
genomic alterations
Description:
Alteration of the genome under radiotherapy
Arm group label:
Interventional Arm
Summary:
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
1. determine the radiation exposure of humans.
2. provide information about the exposure (dose).
3. determine the radiation quality.
4. predict the repair capacity and radiation resistance of an individual.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West
Address:
City:
Essen
Zip:
45147
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Maja Guberina, PD Dr. med. (MD), specialist
Phone:
+492017232321
Email:
maja.guberina@uk-essen.de
Contact backup:
Last name:
Ina Grübel
Investigator:
Last name:
Maja Guberina, PD Dr. med. (MD)
Email:
Principal Investigator
Start date:
June 1, 2024
Completion date:
January 15, 2030
Lead sponsor:
Agency:
University Hospital, Essen
Agency class:
Other
Source:
University Hospital, Essen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06253338
