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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| genomic alterations | Radiation | Alteration of the genome under radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alteration of the genome under radiotherapy | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall Survival | 5 years |
| Progression Free Survival | Progression Free Survival | 5 years |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West | Recruiting | Essen | Germany / NRW | 45147 | Germany |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Radiation induced changes in the genome | 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 |