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Loss of Funding
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast Cancer Radiotherapy | Radiation | 4000-4250 cGy in 15-16 daily fractions |
|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Structural changes in the irradiated breast and the non-irradiated breast | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Born as genetic females
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Zsolt Gabos, MD | AHS-CCI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Acute Radiotherapy Toxicity | 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 . |
| Relationship with Cytomegalovirus infection | There is evidence that being infected with Cytomegalovirus is likely to increase the response of the autotaxin-lysophosphatidates inflammatory cycle in response to radiotherapy. | Seropositivity for CMV will be checked only at baseline. |
| D017437 |
| Skin and Connective Tissue Diseases |