An observational study in Breast Cancer, sponsored by AHS Cancer Control Alberta. Terminated at 1 site in Canada. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by AHS Cancer Control Alberta · Observational
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 4 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →AHS Cancer Control Alberta is the lead sponsor of 182 studies on the registry; 31 are open to participants now.
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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.
Exclusion Criteria:
There is no specific study intervention being used. Samples will be collected from participants undergoing standard of care radiotherapy at pre-specified timepoints.
Radiation: Breast Cancer Radiotherapy
4000-4250 cGy in 15-16 daily fractions
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.
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 (%))
Time frame: 3, 6, 12, 24 and 48 months after RT
Acute Radiotherapy Toxicity
Radiotherapy associated toxicities will be assessed per CTCAE v5.0 by the study investigators.
Time frame: 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.
Time frame: Seropositivity for CMV will be checked only at baseline.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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AHS Cancer Control Alberta