Identifying Prognostic Indicators for the Development of Radiation-induced Breast Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Measurement of the ATX-LPA-inflammatory (chemokines) response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf
- •Age 40 and above.
- •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
排除标准
- •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.
- •Patients who have previously received chemotherapy.
结局指标
主要结局
Measurement of the ATX-LPA-inflammatory (chemokines) response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.
时间窗: 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.
Measurement of the ATX-LPA-inflammatory (cytokines) response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.
时间窗: 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.
Measurement of the ATX-LPA (ATX) inflammatory response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.
时间窗: 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.
Measurement of the ATX-LPA-inflammatory (LPA) response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.
时间窗: 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.
次要结局
- Structural changes in the irradiated breast and the non-irradiated breast(3, 6, 12, 24 and 48 months after RT)
- Acute Radiotherapy Toxicity(Throughout the duration of the study, a total of 4 years .)
- Relationship with Cytomegalovirus infection(Seropositivity for CMV will be checked only at baseline.)