Optimization of Radiation Protection Through Genomic Analyses
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: genomic alterations.
- Who it may be relevant to
- Registry conditions: DNA, Cancer, Radiation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Radiation genomic alterations
Alteration of the genome under radiotherapy
Primary outcome measures
- Alteration of the genome under radiotherapy [Time frame: 5 years]
Secondary outcome measures (3)
- Overall Survival [Time frame: 5 years]
- Progression Free Survival [Time frame: 5 years]
- Radiation induced changes in the genome [Time frame: 2 months to 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Germany · 1 center
- Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases — Essen
Identifiers
NCT: NCT06253338 · 23-11672-BO