Study Of PRoliferation and Apoptosis in Rectal caNcer as Predictive and Prognostic biOmarkers: a Histopathology and Imaging Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Apoptotic index, Ki67 and Geminin in cells per mm cubed from diognostic biopsy
研究概览
简要总结
This study tests biopsy and tissue from patients who have been treated for primary rectal cancer at the Royal Marsden Hospital between 2011 and 2013, who have an mrTRG score at post-chemoradiotherapy MRI. It is a retrospective pilot study to determine the apoptotic and proliferative index count pre and post chemoradiotherapy.
详细描述
The investigators hope to validate the apoptotic and proliferative index as a predictive response marker and lend support to mrTRG as a putative prognostic tool in the treatment pathway for rectal cancer patients. Even though this is a retrospective study, the investigators hope that pre-treatment apoptotic and proliferative scores will correlate to post treatment response and mrTRG scores. In doing so, the investigators can predict how patients will respond to treatment from initial diagnostic biopsies and foresee a patients individual treatment plan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age.
- •Patients with primary adenocarcinoma of the rectum (diagnosed on tissue biopsy and disease spread assessed on CT and MRI).
- •Tumours must be considered sufficiently high-risk to require pre-operative chemoradiotherapy followed by surgery.
- •Patients must have had a pre- and post-treatment MRI scan of the rectum and pelvis.
- •We must have access to stored tissue for each patient
排除标准
- •No pre-operative radiotherapy
- •Patients with synchronous tumours
- •Patients under the age of 18 years
结局指标
主要结局
Apoptotic index, Ki67 and Geminin in cells per mm cubed from diognostic biopsy
时间窗: Tissue removed at diagnosis (approximately 15 weeks prior to surgery)
Tissue biopsy taken at endoscopy to confirm cancer diagnosis is studied
Apoptotic index, Ki67 and Geminin in cells per mm cubed from resected tumour
时间窗: Tissue removed during operation
Tissue removed during surgery (to resect tumour) is studied
次要结局
- Time to local recurrence(At one and three years)
- Overall Survival (OS)(At one and three years)
- Disease Free Survival (DFS)(At one and three years)