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NCT Number: NCT06253338

Optimization of Radiation Protection Through Genomic Analyses

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West

Essen, Germany / NRW, 45147, Germany

Location status: Recruiting

Location contact

Ina Grübel

CONTACT

Maja Guberina, PD Dr. med. (MD)

PRINCIPAL_INVESTIGATOR

Maja Guberina, PD Dr. med. (MD), specialist

CONTACT

[email protected]

+492017232321

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

genomic alterations

Radiation

Alteration of the genome under radiotherapy

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study 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

Acronym: ORtogether

Important dates

Study start
2024
Primary completion
2025
Study completion
2030
First posted
Feb 12, 2024
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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