Optimization of Radiation Protection Through Genomic Analyses

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Essen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • genomic alterations

    Radiation

    Alteration of the genome under radiotherapy

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Interventional ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
5 years

Secondary outcomes

1

Overall Survival

Overall Survival

Time frame
5 years
2

Progression Free Survival

Progression Free Survival

Time frame
5 years
3

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

Time frame
2 months to 5 years

Other outcomes

Sponsors and contacts

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