DNAORtogetherNCT06253338
Optimization of Radiation Protection Through Genomic Analyses
A study testing genomic alterations in people with DNA and Cancer, run by University Hospital, Essen at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- genomic alterations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2024to 15 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG 0/1 no prior treatment no prior cancer diagnosis thoracic or head and neck cancer
Who cannot join
- prior treatment (chemotherapy, radiotherapy, etc.) prior cancer diagnosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West
Essen, Germany / NRW, 45147
Maja Guberina, PD Dr. med. (MD), specialist, +492017232321, maja.guberina@uk-essen.de
Ina Grübel
About this study
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
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
- determine the radiation exposure of humans.
- provide information about the exposure (dose).
- determine the radiation quality.
- predict the repair capacity and radiation resistance of an individual.
Read the 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.
- Being tested
- genomic alterations
- Keywords
- DNA, cancer, sequencing technologies, lymphocyte, genomic, loosely ionizing radiation, Linear Energy Transfer, outcome, thoracic radiotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genomic alterationsRadiation
Alteration of the genome under radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | Not described Receives: Radiation: genomic alterations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (3)
Overall Survival
Overall Survival
Measured: 5 years
Progression Free Survival
Progression Free Survival
Measured: 5 years
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
Measured: 2 months to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Jun 2024
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DNAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maja Guberina, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253338
- Sponsor's protocol ID
- 23-11672-BO
- Acronym
- ORtogether
- Status last verified
- Oct 2026
- First submitted
- 30 Dec 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06253338
- Acronym / sponsor ID
- ORtogether / 23-11672-BO
- Keywords
- DNA, cancer, sequencing technologies, lymphocyte, genomic, loosely ionizing radiation, Linear Energy Transfer, outcome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Jan 2030 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- determine the radiation exposure of humans.
- provide information about the exposure (dose).
- determine the radiation quality.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Radiation: genomic alterations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ECOG 0/1 no prior treatment no prior cancer diagnosis thoracic or head and neck cancer
Key exclusion criteria (1 listed)
- prior treatment (chemotherapy, radiotherapy, etc.) prior cancer diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genomic alterationsAlteration of the genome under radiotherapy | Radiation | Interventional Arm |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West
Essen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing genomic alterations in people with DNA and Cancer, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alteration of the genome under radiotherapy (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.