Optimization of Radiation Protection Through Genomic Analyses

Cancer Clinical Trial

— ORtogether  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06253338
• Other study ID #: 23-11672-BO
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: January 15, 2030

Study information

• Verified date: April 2024
• Source: University Hospital, Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. predict the repair capacity and radiation resistance of an individual.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 15, 2030
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• DNA
• Radiation

Intervention

Radiation:
• genomic alterations
Alteration of the genome under radiotherapy

Locations

Country	Name	City	State
Germany	Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West	Essen	Germany / NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Overall Survival	Overall Survival	5 years
Secondary	Progression Free Survival	Progression Free Survival	5 years
Secondary	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