Radiation ToleranceSENSNCT05566613
Prediction of Individual Radiosensitivity During Radiotherapy for Breast Cancer Patients
An observational study of Radiation Tolerance and Breast Neoplasms, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Non-randomized clinical cohort study investigating if single nucleotide polymorphism (SNP) or inflammatory markers can predict radiosensitivity in breast cancer patients receiving radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Tolerance, Breast Neoplasms
- What is being tested?
- Blood sample
- Type of treatment
- Surgery or procedure
- How many people
- 550 participants
- Where
- 1 siteSweden
- Study dates
- 9 May 2022to 31 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving postoperative radiotherapy for breast cancer.
Who may be able to join
- Patients receiving adjuvant radiotherapy for breast cancer 2,67 Gy x 15 (or a radio biologically equivalent dose)
- > 18 years
- Being able to read and understand patient information in Swedish
- Signed informed consent
Who cannot join
- Ongoing infection
- Fever >37,9 degrees Celsius
- Unable to follow study protocol
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 17176
Mattias Hedman, MD PhD, +46812370000, mattias.hedman@regionstockholm.se
About this study
Official title: Prediction of Individual Radiosensitivity During Radiotherapy for Breast Cancer Patients, the Role of Genetic and Inflammatory Markers
Non-randomized clinical cohort study investigating if single nucleotide polymorphism (SNP) or inflammatory markers can predict radiosensitivity in breast cancer patients receiving radiotherapy.
Read the detailed description
Objectives
- To explore if acute radiation response can be predicted in patients, by analyzing a single nucleotide polymorphism (SNP rs1801516) sampled prior to radiotherapy.
- If acute radiation response can be predicted in patients, by analyzing genetic and inflammatory markers in blood sampled prior to radiotherapy.
- If late side effects from radiotherapy can be predicted in patients, by analyzing genetic and inflammatory markers in blood sampled before and after radiotherapy.
- If there is a correlation between genetic and inflammatory markers in blood and patient reported outcome measures (PROM) and quality of life (QoL).
- To train an algorithm to correlate the appearance of skin before radiotherapy and the extent of skin reaction to radiotherapy
Outline This study is a non-randomized clinical cohort study. Adults with breast cancer will be invited to participate in the study. Blood will be collected before start of treatment and after radiotherapy is completed. Quality of life (QoL) and symptoms will be assessed before and weekly during treatment, at the end of treatment and after one year. A total of 550 patients is expected to be recruited.
- Conditions
- Radiation Tolerance, Breast Neoplasms
- Being tested
- Blood sample
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleRadiation
Blood sample before and after radiotherapy and photography before radiotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute radiation dermatitis grading criteria
Acute radiation dermatitis grading criteria according to the Radiation Therapy Oncology Group. Minimum value 1 and maximum value 4, higher value means a worse outcome
Measured: Before and during treatment and after one year
Secondary outcomes (5)
Quality of life (QoL)
Quality of life determined by European Organisation for Research and Treatment of Cancer questionnaire QLQ-C30
Measured: Before and during treatment and after one year
Breast cancer specific Quality of life (QoL)
Quality of life determined by European Organisation for Research and Treatment of Cancer questionnaire QLQ-BR23
Measured: Before and during treatment and after one year
Cancer related fatigue Quality of life (QoL)
Quality of life determined by European Organisation for Research and Treatment of Cancer questionnaire QLQ-FA12
Measured: Before and during treatment and after one year
Number of participants with heart disease
Heart disease as described in patient chart diagnosed after radiotherapy
Measured: at five years
Number of participants with lung disease
Lung disease as described in patient chart diagnosed after radiotherapy and related to the radiotherapy treatment area
Measured: at five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start9 May 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ToleranceStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm University
- Responsible party
- Principal investigator, Mattias Hedman, Karolinska University Hospital
- Investigators
- Mattias Hedman, MD PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566613
- Sponsor's protocol ID
- 21/079
- Acronym
- SENS
- Status last verified
- Sep 2022
- First submitted
- 12 Jun 2022
- Last updated
- 4 Oct 2022
- 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 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Individual Radiosensitivity During Radiotherapy for Breast Cancer Patients, the Role of Genetic and Inflammatory Markers
- ClinicalTrials.gov ID
- NCT05566613
- Acronym / sponsor ID
- SENS / 21/079
- Conditions
- Radiation Tolerance, Breast Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Stockholm University
- Study start
- 9 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Oct 2022 (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.
Non-randomized clinical cohort study investigating if single nucleotide polymorphism (SNP) or inflammatory markers can predict radiosensitivity in breast cancer patients receiving radiotherapy.
Detailed description
Objectives
- To explore if acute radiation response can be predicted in patients, by analyzing a single nucleotide polymorphism (SNP rs1801516) sampled prior to radiotherapy.
- If acute radiation response can be predicted in patients, by analyzing genetic and inflammatory markers in blood sampled prior to radiotherapy.
- If late side effects from radiotherapy can be predicted in patients, by analyzing genetic and inflammatory markers in blood sampled before and after radiotherapy.
- If there is a correlation between genetic and inflammatory markers in blood and patient reported outcome measures (PROM) and quality of life (QoL).
- To train an algorithm to correlate the appearance of skin before radiotherapy and the extent of skin reaction to radiotherapy
Outline This study is a non-randomized clinical cohort study. Adults with breast cancer will be invited to participate in the study. Blood will be collected before start of treatment and after radiotherapy is completed. Quality of life (QoL) and symptoms will be assessed before and weekly during treatment, at the end of treatment and after one year. A total of 550 patients is expected to be recruited.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving postoperative radiotherapy for breast cancer.
Key inclusion criteria (4 listed)
- Patients receiving adjuvant radiotherapy for breast cancer 2,67 Gy x 15 (or a radio biologically equivalent dose)
- > 18 years
- Being able to read and understand patient information in Swedish
- Signed informed consent
Key exclusion criteria (3 listed)
- Ongoing infection
- Fever >37,9 degrees Celsius
- Unable to follow study protocol
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 |
|---|---|---|
| Blood sampleBlood sample before and after radiotherapy and photography before radiotherapy | Radiation | – |
Primary outcome
Acute radiation dermatitis grading criteria
Time frame: Before and during treatment and after one year
Acute radiation dermatitis grading criteria according to the Radiation Therapy Oncology Group. Minimum value 1 and maximum value 4, higher value means a worse outcome
5 secondary outcomes
Quality of life (QoL)
Time frame: Before and during treatment and after one year
Breast cancer specific Quality of life (QoL)
Time frame: Before and during treatment and after one year
Cancer related fatigue Quality of life (QoL)
Time frame: Before and during treatment and after one year
Number of participants with heart disease
Time frame: at five years
Number of participants with lung disease
Time frame: at five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
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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.
Mattias Hedman, MD PhD principal investigator
Karolinska University Hospital
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 Radiation Tolerance and Breast Neoplasms, run by Karolinska University Hospital at 1 site in Sweden.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Oct 2022. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mattias Hedman, MD PhD (+46812370000, mattias.hedman@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute radiation dermatitis grading criteria (time frame: Before and during treatment and after one year). 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 4 Oct 2022.