Breast CancerNCT01975558
The Radiation Metabolic Signature of Patient Undergoing Radiotherapy. A Pilot Study
An observational study of Breast Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Rationale: Local radiotherapy applied in the treatment of tumors changes the metabolic profile in the exposed area and/or systemically and specific radiation biomarkers can be identified in the respective matrices. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Sampling at baseline, one week after baseline, two weeks after baseline and Sampling at baseline, during radiotherapy and after
- How many people
- 34 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Jun 2014to 12 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Twenty patients with breast cancer. Ten healthy volunteers.
Radiotherapy: cancer treatment with total doses of more than 30 Gy, single fraction dose of at least 1.8 Gy/die. Big treatment/target volume. Age over 50 years, according to postmenopausal status. No simultaneous chemotherapy in breast cancer patients. For the control group: healthy volunteers (women), age over 50 years, according to postmenopausal status; no previous chemo - and cancer therapy.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Radio-Oncology, Bern University Hospital
Bern, 3010
About this study
Rationale: Local radiotherapy applied in the treatment of tumors changes the metabolic profile in the exposed area and/or systemically and specific radiation biomarkers can be identified in the respective matrices.
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.
Read the detailed description
Background
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
- Breast Cancer
- Being tested
- Sampling at baseline, one week after baseline, two weeks after baseline, Sampling at baseline, during radiotherapy and after
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampling at baseline, one week after baseline, two weeks after baselineBiological
Sampling at baseline, during radiotherapy and afterBiological
| Study group | Role | What they receive |
|---|---|---|
| Control group A | Control group. The group will undergo blood, urine, sebum, and saliva sampling. Receives: Biological: 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. Receives: Biological: 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. Receives: Biological: Sampling at baseline, during radiotherapy and after |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in radiation metabolites
To affirm the results from animal model in radiation metabolomics in human radiotherapy treatment.
Measured: During radiation treatment, expected to be ca. 5 weeks
Secondary outcomes (1)
New potential biomarkers for radiation biodosimetry
To find new potential biomarkers for radiation biodosimetry in humans and to identify changes in different sequences in measuring from local and systemic material.
Measured: During and after radiation treatment (at baseline, week 1,5 + 6, 8 weeks after therapy end)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study start26 Jun 2014
- Primary completion12 Nov 2019
- Study completion12 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristina Loessl, MD, Study chair, Dept. of Radiation Oncology, University Hospital, Inselspital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975558
- Sponsor's protocol ID
- 181/11
- Status last verified
- Feb 2020
- First submitted
- 4 Sep 2013
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Radiation Metabolic Signature of Patient Undergoing Radiotherapy. A Pilot Study
- ClinicalTrials.gov ID
- NCT01975558
- Acronym / sponsor ID
- 181/11
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 26 Jun 2014 (actual)
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- 12 Nov 2019 (actual)
- First posted
- 4 Nov 2013 (estimated)
- 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.
Rationale: Local radiotherapy applied in the treatment of tumors changes the metabolic profile in the exposed area and/or systemically and specific radiation biomarkers can be identified in the respective matrices.
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.
Detailed description
Background
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group A | – | Biological: Sampling at baseline, one week after baseline, two weeks after baselineControl group. The group will undergo blood, urine, sebum, and saliva sampling. |
| Breast cancer B | – | Biological: Sampling at baseline, during radiotherapy and afterBreast cancer (60 Gy). The group will undergo blood, urine, sebum, and saliva sampling within the irradiation field. |
| Breast cancer C | – | Biological: Sampling at baseline, during radiotherapy and afterBreast cancer (60 Gy). The group will undergo blood, urine, sebum, and saliva sampling outside of the irradiation field, e.g. at the arm. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty patients with breast cancer. Ten healthy volunteers.
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 |
|---|---|---|
| Sampling at baseline, one week after baseline, two weeks after baseline | Biological | Control group A |
| Sampling at baseline, during radiotherapy and after | Biological | Breast cancer B, Breast cancer C |
Primary outcome
Change from baseline in radiation metabolites
Time frame: During radiation treatment, expected to be ca. 5 weeks
To affirm the results from animal model in radiation metabolomics in human radiotherapy treatment.
1 secondary outcome
New potential biomarkers for radiation biodosimetry
Time frame: During and after radiation treatment (at baseline, week 1,5 + 6, 8 weeks after therapy end)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
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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. This study is not recruiting at the moment.
Kristina Loessl, MD study chair
Dept. of Radiation Oncology, University Hospital, Inselspital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 2 Mar 2020. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in radiation metabolites (time frame: During radiation treatment, expected to be ca. 5 weeks). 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 2 Mar 2020.