Optimization of Radiation Protection Through Genomic Analyses

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

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NCT-Nummer:
NCT06253338

Studienbeginn:
Juni 2024

Letztes Update:
23.04.2024

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital, Essen

Collaborator:
-

Studienlocations
(1 von 1)

Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West
45147 Essen
(Nordrhein-Westfalen)
Germany» Google-Maps
Ansprechpartner:
Maja Guberina, PD Dr. med. (MD), specialist
Phone: +492017232321
E-Mail: maja.guberina@uk-essen.de

Ina Grübel» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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

Secondary outcome:

1. Overall Survival (Time Frame - 5 years):
Overall Survival

2. Progression Free Survival (Time Frame - 5 years):
Progression Free Survival

3. 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

Geprüfte Regime

genomic alterations:
Alteration of the genome under radiotherapy

Quelle: ClinicalTrials.gov

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