- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05031065
Prognostic Indicators for Radiation-induced Breast Fibrosis
January 26, 2024 updated by: AHS Cancer Control Alberta
Identifying Prognostic Indicators for the Development of Radiation-induced Breast Fibrosis
To study the inflammatory response during and after radiotherapy, especially by measuring the concentration of an enzyme called autotaxin and its product LPA in the blood plasma.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
To study the inflammatory response during and after radiotherapy, especially by measuring the concentration of an enzyme called autotaxin and its product LPA in the blood plasma.
Autotaxin and LPA cause fibrosis in other situation, but they have not been tested in radiation-induced fibrosis.
We will determine if the duration and magnitude of the autotaxin and LPA responses are prognostic for the 15-28% of patients who will develop fibrosis.
This fibrosis will be detected by ultrasound and a novel application of elastography, which should provide much earlier and quantifiable fibrotic changes compared to conventional physical examination.
Study Type
Observational
Enrollment (Estimated)
27
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zsolt Gabos, MD
- Phone Number: 780-432-8783
- Email: Zsolt.Gabos@ahs.ca
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 1Z2
- Recruiting
- Cross Cancer Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
We will study a low risk group of 27 post-menopausal patients with luminal A breast cancer after they have received breast conserving surgery (lumpectomy).
Women who have smoked or received chemotherapy will be excluded to minimize variables.
Description
Inclusion Criteria:
- Female participants capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf
- Post-menopausal.
- Treatment with breast conserving surgery.
- Intended adjuvant whole breast radiotherapy dose to a dose of 40-42.5 Gy in 15-16 fractions.
- Luminal A subtype as determined by clinipathologic factors (ER/PR positive, Her-2 negative, low Ki-67 or low OncotypeDx recurrence score
Exclusion Criteria:
- Women who have smoked within the last 5 years
- Patients requiring adjuvant chemotherapy.
- Requirement for regional nodal radiotherapy.
- Requirement for tumour bed boost.
- Breast implants
- Patients to be treated with partial breast irradiation.
- Uncontrolled intercurrent illness or active infection.
- Patients who have previously received chemotherapy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Women undergoing radiation treatment after lumpectomy for breast cancer.
There is no specific study intervention being used.
Samples will be collected from participants undergoing standard of care radiotherapy at pre-specified timepoints.
|
4000-4250 cGy in 15-16 daily fractions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of the ATX-LPA (ATX) inflammatory response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.
Time Frame: Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.
|
Measurement of longitudinal changes in plasma ATX in the irradiated breast.
|
Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.
|
Measurement of the ATX-LPA-inflammatory (LPA) response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.
Time Frame: Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.
|
Measurement of longitudinal changes in plasma LPA in the irradiated breast.
|
Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.
|
Measurement of the ATX-LPA-inflammatory (cytokines) response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.
Time Frame: Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.
|
Measurement of longitudinal changes in plasma cytokines in the irradiated breast.
|
Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.
|
Measurement of the ATX-LPA-inflammatory (chemokines) response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.
Time Frame: Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.
|
Measurement of longitudinal changes in plasma chemokines in the irradiated breast.
|
Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute Radiotherapy Toxicity
Time Frame: Throughout the duration of the study, a total of 4 years .
|
Radiotherapy associated toxicities will be assessed per CTCAE v5.0 by the study investigators.
|
Throughout the duration of the study, a total of 4 years .
|
Structural changes in the irradiated breast and the non-irradiated breast
Time Frame: 3, 6, 12, 24 and 48 months after RT
|
The ultrasound procedure will provide a 3D analysis of the breast structure as well as a measurement of breast elasticity.
Fibrotic changes in the breast will be measured by combining the 3D analysis and breast elasticity indices (median (kPa), IQR (kPA) and IQR/median (%))
|
3, 6, 12, 24 and 48 months after RT
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zsolt Gabos, MD, AHS-CCI
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 24, 2024
Primary Completion (Estimated)
July 1, 2025
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
August 25, 2021
First Submitted That Met QC Criteria
August 30, 2021
First Posted (Actual)
September 1, 2021
Study Record Updates
Last Update Posted (Estimated)
January 29, 2024
Last Update Submitted That Met QC Criteria
January 26, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIT-0026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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