NCT06253338

Brief 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. 1.determine the radiation exposure of humans.
  2. 2.provide information about the exposure (dose).
  3. 3.determine the radiation quality.
  4. 4.predict the repair capacity and radiation resistance of an individual.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
44mo left

Started Jun 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Jun 2024Jan 2030

First Submitted

Initial submission to the registry

December 30, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2030

Expected
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

1.5 years

First QC Date

December 30, 2023

Last Update Submit

September 25, 2024

Conditions

DNACancerRadiation

Keywords

DNAcancersequencing technologieslymphocytegenomicloosely ionizing radiationLinear Energy Transferoutcomethoracic radiotherapy

Outcome Measures

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

    5 years

Secondary Outcomes (3)

  • Overall Survival

    5 years

  • Progression Free Survival

    5 years

  • Radiation induced changes in the genome

    2 months to 5 years

Study Arms (1)

Interventional Arm

EXPERIMENTAL
Radiation: genomic alterations

Interventions

genomic alterationsRADIATION

Alteration of the genome under radiotherapy

Interventional Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ECOG 0/1 no prior treatment no prior cancer diagnosis thoracic or head and neck cancer

You may not qualify if:

  • prior treatment (chemotherapy, radiotherapy, etc.) prior cancer diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Essen, Germany / NRW, 45147, Germany

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med. (MD) / specialist forradiation oncology, senior consultant

Study Record Dates

First Submitted

December 30, 2023

First Posted

February 12, 2024

Study Start

June 1, 2024

Primary Completion

December 15, 2025

Study Completion (Estimated)

January 15, 2030

Last Updated

September 27, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)