PICTURE Breast XS: Patient Information Combined for Local Therapy oUtcome Assessment in bREast Cancer - Cross-sectional (PICTURE XS)
研究概览
地位
条件
详细说明
Breast cancer is the most common cancer to affect women in Europe, having a lifetime risk of 1 in 9. It is an increasingly treatable disease, and 10-year survival now exceeds 80%. The primary treatment for breast cancer is surgery, which may be used in conjunction with adjuvant therapies, such as chemotherapy and radiotherapy. Given the high breast cancer survival rate, many women will live for many years with the potentially disfiguring aesthetic consequences of their surgical and therapeutic treatment. A good aesthetic outcome is an important endpoint for breast cancer treatment and is closely related to psychosocial recovery and quality of life.
When a woman faces a breast cancer diagnosis, and surgery is proposed, several options are available. The decision as to which type of surgery to offer patients is largely subjective and based almost exclusively on the judgment and experience of the clinician. The cosmetic outcome of surgery is a function of many factors including tumour size and location, the volume of the breast, its density, and the dose and distribution of radiotherapy. In breast-conserving surgery, there is evidence that approximately 30% of women receive a suboptimal or poor aesthetic outcome; however there is currently no standardised method of identifying these women.
The PICTURE project aims to address these issues by providing objective tools, tailored to the individual patient, to predict the aesthetic outcome of local treatment. Using a combination of 3D photography and routinely acquired radiological images (i.e. mammography, ultrasound and MRI, when available), together with information about the tumour (size, location, shape etc.) we will develop techniques to biomechanically model the anatomy of the breast and the effect of surgical removal of cancerous tissue. This digital patient representation and associated predictive tools will enable alternative surgical strategies to be explored and the consequences of the available options, with respect to the appearance of the breast, to be visualised. This will aid communication with the patient of the type of breast surgery recommended by the surgeon, and will empower patients to take an active role in a shared decision making process.
The study will develop tools to enable the patient's aesthetic appearance after treatment to be objectively evaluated. Current techniques use subjective methods, such as assessment by an expert panel, or computer analysis of 2-dimensional photography to estimate, for instance, breast asymmetry. By adopting recent developments in low cost 3D photography and depth sensing technology, we will develop a standardised, reproducible analysis tool which will base the aesthetic outcome evaluation on both the 3-dimensional shape of the reconstructed breast and its volume. This will establish standardised quality assurance and evaluation procedures, enabling institutions across Europe to be compared and factors that have a positive or negative impact on surgical outcome identified.
In summary, the demonstrator created by the PICTURE project will integrate models of surgical techniques and treatment schemes, clinical patient data, multi-modal imaging and individualised models of patient anatomy to build a personalised, digital representation of the patient. The aim is for this to be used as an aid to surgical planning, via simulation of the cosmetic effects of breast conserving surgery, as a decision support tool to communicate the available options to the patient and to enable standardised evaluation and a safe outcome of the procedure. The demonstrator aims to empower patients and will have a direct impact on their care and quality of life.
研究类型
注册 (实际的)
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Women who have undergone breast conserving surgery for early breast cancer more than one year ago.
- Written informed consent obtained.
Exclusion Criteria:
- Unable to provide written informed consent.
- Younger than 18 years.
- Benign breast disease.
- Women who have had a mastectomy.
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Evaluate the factors that determine aesthetic outcome after treatment for early breast cancer
大体时间:Single assessment on one day, beyond one year from date of primary surgery.
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The primary aim of this study is to evaluate the factors that determine aesthetic outcome after treatment for early breast cancer, based on a consensual classification obtained with a consensus panel.
The information thus obtained will be integrated into the demonstrator (a personalised digital representation of the patient).
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Single assessment on one day, beyond one year from date of primary surgery.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Comparison of the characteristics of this patient group with the group used to make the demonstrator in PICTURE L (composite outcome).
大体时间:Single assessment on one day, beyond one year from date of primary surgery.
|
Comparison of the characteristics of the primary tumour in this patient group with the group used to make the demonstrator.
The characteristics include: primary tumour side, quadrant, size, and hormone receptor status.
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Single assessment on one day, beyond one year from date of primary surgery.
|
Comparison of the characteristics of this patient group with the group used to make the demonstrator in PICTURE L (composite outcome).
大体时间:Single assessment on one day, beyond one year from date of primary surgery.
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Comparison of the characteristics of treatment received in this patient group with the group used to make the demonstrator.
The characteristics include: details of surgery, chemotherapy, radiotherapy and adjuvant hormonal therapy.
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Single assessment on one day, beyond one year from date of primary surgery.
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Comparison of the characteristics of this patient group with the group used to make the demonstrator in PICTURE L (composite outcome).
大体时间:Single assessment on one day, beyond one year from date of primary surgery.
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Comparison of the characteristics assessed by questionnaire of this patient group with the group used to make the demonstrator.
The characteristics include: measures assessed by the questionnaires (EQ-5D-5L, QLQ-C30 & BR23, and BREAST-Q).
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Single assessment on one day, beyond one year from date of primary surgery.
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合作者和调查者
合作者
调查人员
- 首席研究员:Mo Keshtgar, MB BS, FRCS、Royal Free Hospital NHS Foundation Trust
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- UCL 13/0354
- 14/LO/0428 (其他标识符:HRA NRES Committee)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
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