NCT06046664进行中（未招募）不适用
A Study Assessing the Impact of the Oncotype DX DCIS Score on Radiotherapy Decision Making in the United Kingdom
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Change in radiotherapy recommendation by clinician
研究概览
简要总结
Prospective single centre study of patients with DCIS that have undergone breast conservation surgery.
详细描述
This is a single centre (Royal Marsden Hospital - Chelsea and Sutton) non-randomised trial investigating whether the Oncotype DX DCIS score changes the radiotherapy recommendation made by clinical oncologists in patients with low to moderate risk DCIS following breast conserving surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of DCIS
- •DCIS treated with breast conserving surgery
排除标准
- •Prior treatment for DCIS or invasive breast cancer in ipsilateral breast.
- •Patients with contra-indications to radiotherapy, including prior breast radiotherapy
- •Patients who undergo mastectomy for DCIS
- •Age < 45 years old
- •Patients with > 25mm DCIS
- •Patients with multifocal DCIS (defined as more than 1 distinct focus of DCIS with at least 50mm of intervening benign tissue)
- •Patients with invasive (including microinvasion) disease
- •Patients with positive axillary nodal disease (including isolated tumour cells)
- •Patients with close (<1mm) or positive radial margins (unless maximally surgically excised or no further DCIS on re-excision)
- •Patients recommended adjuvant endocrine therapy
结局指标
主要结局
Change in radiotherapy recommendation by clinician
时间窗: end of trial (2 years)
Percentage of clinical oncology recommendations regarding radiotherapy that change pre- and post- Oncotype DX DCIS.
次要结局
- Determine change in patient decisional conflict pre and post Oncotype DX DCIS.(end of trial (2 years))
- Determine whether the Oncotype DX DCIS score results in a change in patient decision for adjuvant radiotherapy.(end of trial (2 years))
- Determine whether the local recurrence risk estimated by clinical oncologists agrees with the local recurrence risk calculated by the Oncotype DX DCIS score (for all recurrences and for invasive recurrences only).(end of trial (2 years))
- Determine change in patient anxiety pre and post Oncotype DX DCIS.(end of trial (2 years))
- Determine patient, tumour and clinician related factors that are associated with patients changing their decision regarding radiotherapy.(end of trial (2 years))
- Determine patient, tumour and clinician related factors that are associated with patients' final decision to have radiotherapy.(end of trial (2 years))
- Determine patient, tumour and clinician factors that are associated with clinicians changing their decision regarding radiotherapy.(end of trial (2 years))
研究者
研究点 (2)
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