Breast CancerNCT05170087
Radiomic Analysis for Predicting Treatment Response and Clinical Outcomes in Malignancies
An observational study of Breast Cancer and Head and Neck Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
In this study, the investigators aim to undertake a retrospective analysis of CT and MRI scans for patients undergoing radiation treatment to develop radiomic signatures to predict treatment response and clinical outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer, Head and Neck Cancer, Brain Cancer
- How many people
- 1,200 participants
- Where
- 1 siteCanada
- Study dates
- 2 Mar 2020to Mar 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Those treated with radiation at Odette Cancer Centre between 2010 and 2019 after being diagnosed with a breast, brain, head and neck, or gynecological malignancy.
Who may be able to join
- Breast, head and neck, brain, and gynecological malignancies
- Treated with radiation at Odette Cancer Centre between 2010 and 2019
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiomic Analysis of CT and MRI Scans for Predicting Treatment Response and Clinical Outcomes in Patients With Breast, Brain, Head-neck and Gynecological Malignancies
In this study, the investigators aim to undertake a retrospective analysis of CT and MRI scans for patients undergoing radiation treatment to develop radiomic signatures to predict treatment response and clinical outcomes.
Read the detailed description
Imaging in oncology has widespread application with modalities like ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET) having a well-established role particularly in diagnosis, staging, assessment of treatment response, and surveillance. With the applications of radiomics in oncology, the potential of imaging as a non-invasive biomarker in treatment response, as well as genotypic characterization, has been recognized. Radiomics has the potential to tailor way towards precision oncology with the development of biomarkers that can guide personalized treatments. In this study, the investigators aim at developing CT and MRI radiomic signatures as potential biomarkers to predict treatment response and clinical outcomes for patients treated with radiation having breast, brain, head and neck, and gynecological malignancies.
- Conditions
- Breast Cancer, Head and Neck Cancer, Brain Cancer, Gynecologic Cancer
- Medical subject headings
- Breast Neoplasms, Head and Neck Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast malignancies | Those diagnosed with breast malignancies | |
| Head and Neck malignancies | Those diagnosed with head and neck malignancies | |
| Brain malignancies | Those diagnosed with brain malignancies | |
| Gynecological malignancies | Those diagnosed with gynecological malignancies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of imaging biomarkers in predicting treatment response for breast, brain, head-neck, and gynecological malignancies
Development of imaging biomarkers in predicting treatment response
Measured: 1 year
Development of imaging biomarkers in predicting clinical outcomes (survival/toxicity) for breast, brain, head-neck, and gynecological malignancies
Development of imaging biomarkers in predicting clinical outcomes (survival/toxicity)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start2 Mar 2020
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
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 Sunnybrook Health Sciences CentreThe 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
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gregory Czarnota, Sunnybrook Health Sciences Centre
- Investigators
- Gregory Czarnota, Ph.D. M.D., Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170087
- Sponsor's protocol ID
- 034-2020
- Status last verified
- Apr 2023
- First submitted
- 23 Nov 2021
- Last updated
- 19 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiomic Analysis of CT and MRI Scans for Predicting Treatment Response and Clinical Outcomes in Patients With Breast, Brain, Head-neck and Gynecological Malignancies
- ClinicalTrials.gov ID
- NCT05170087
- Acronym / sponsor ID
- 034-2020
- Conditions
- Breast Cancer, Head and Neck Cancer, Brain Cancer, Gynecologic Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 27 Dec 2021 (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.
In this study, the investigators aim to undertake a retrospective analysis of CT and MRI scans for patients undergoing radiation treatment to develop radiomic signatures to predict treatment response and clinical outcomes.
Detailed description
Imaging in oncology has widespread application with modalities like ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET) having a well-established role particularly in diagnosis, staging, assessment of treatment response, and surveillance. With the applications of radiomics in oncology, the potential of imaging as a non-invasive biomarker in treatment response, as well as genotypic characterization, has been recognized. Radiomics has the potential to tailor way towards precision oncology with the development of biomarkers that can guide personalized treatments. In this study, the investigators aim at developing CT and MRI radiomic signatures as potential biomarkers to predict treatment response and clinical outcomes for patients treated with radiation having breast, brain, head and neck, and gynecological malignancies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Breast malignancies | – | –Those diagnosed with breast malignancies |
| Head and Neck malignancies | – | –Those diagnosed with head and neck malignancies |
| Brain malignancies | – | –Those diagnosed with brain malignancies |
| Gynecological malignancies | – | –Those diagnosed with gynecological malignancies |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Those treated with radiation at Odette Cancer Centre between 2010 and 2019 after being diagnosed with a breast, brain, head and neck, or gynecological malignancy.
Key inclusion criteria (2 listed)
- Breast, head and neck, brain, and gynecological malignancies
- Treated with radiation at Odette Cancer Centre between 2010 and 2019
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of imaging biomarkers in predicting treatment response for breast, brain, head-neck, and gynecological malignancies
Time frame: 1 year
Development of imaging biomarkers in predicting treatment response
Development of imaging biomarkers in predicting clinical outcomes (survival/toxicity) for breast, brain, head-neck, and gynecological malignancies
Time frame: 1 year
Development of imaging biomarkers in predicting clinical outcomes (survival/toxicity)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
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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.
Gregory Czarnota, Ph.D. M.D. principal investigator
Sunnybrook Health Sciences Centre
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 and Head and Neck Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 2 inclusion and 1 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 19 Apr 2023. 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 Canada. 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?
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?
Development of imaging biomarkers in predicting treatment response for breast, brain, head-neck, and gynecological malignancies (time frame: 1 year). The study lists 2 primary outcomes in all. 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 19 Apr 2023.