The Radiation Metabolic Signature of Patient Undergoing Radiotherapy. A Pilot Study
NCT ID: NCT01975558
Last Updated: 2020-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
34 participants
OBSERVATIONAL
2014-06-26
2019-11-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Purpose: This is a pilot study to verify in humans the results obtained from two animal models exposed to ionizing gamma-radiation. The classification of patients results from the treatment volume of radiotherapy for cancer disease. Two patient groups with breast cancer undergoing high-dose radiotherapy are selected and compared to control group of age matched healthy women.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Partial Breast Re-irradiation in Women in Women with Locally Recurrent Breast Cancer Previously Treated with Conservative Surgery and Whole Breast Irradiation
NCT05772390
Association of Adjuvant Radiotherapy of Non-metastatic Breast Carcinoma With Immunomodulation and Circulating Tumor Cell Phenotype in Relation to Patient Age.
NCT04902937
Prediction of Individual Radiosensitivity During Radiotherapy for Breast Cancer Patients
NCT05566613
Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy
NCT03935802
Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy
NCT05665920
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Humans are exposed to ionizing radiation from several sources. Gamma-radiation exposure induces thereby both short- and long-term adverse effects. The radiation injuries to be expected in humans in the acute stage (days to some weeks after radiation exposure) correlate with the radiation dose that the individual has received. With very high doses gastrointestinal syndrome leads to death within a few days. The survival of the individual in the acute stage is therefore dramatically dependent on the rapid application of suitable therapies. It is decisive here to identify in the shortest possible time those persons who have been exposed to a critical radiation dose and to estimate the dose received in order to apply an adequate therapy. There are no satisfying test methods available today, which would enable the mass screening for radiation injury.
Furthermore to identify changes in the local or systemic human metabolic fingerprint, which are useful for the prediction of the individual sensitivity of patients to radiotherapy and / or lead to a better understanding of the molecular mechanisms involved in radiotherapy.
Objective
Primary: The primary endpoint is to affirm the results from the animal model in radiation metabolomics in human radiotherapy treatment.
Secondary: The secondary endpoints are to find new potential biomarkers for radiation biodosimetry in humans and to identify changes in the different sequences in measuring from local (sebum) and systemic (blood, saliva and urine) material.
Methods
Gas chromatographic separation and mass spectrometric detection of the metabolites present in a given matrix (urine, saliva, plasma, sebum).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control group A
Control group. The group will undergo blood, urine, sebum, and saliva sampling.
Sampling at baseline, one week after baseline, two weeks after baseline
Breast cancer B
Breast cancer (60 Gy). The group will undergo blood, urine, sebum, and saliva sampling within the irradiation field.
Sampling at baseline, during radiotherapy and after
Breast cancer C
Breast cancer (60 Gy). The group will undergo blood, urine, sebum, and saliva sampling outside of the irradiation field, e.g. at the arm.
Sampling at baseline, during radiotherapy and after
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sampling at baseline, one week after baseline, two weeks after baseline
Sampling at baseline, during radiotherapy and after
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
50 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kristina Loessl, MD
Role: STUDY_CHAIR
Dept. of Radiation Oncology, University Hospital, Inselspital Bern
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Radio-Oncology, Bern University Hospital
Bern, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
181/11
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.