Exploring the Link Between Cancer Genetics and Persistent Post-surgical Pain (PPSP) Following Breast Cancer Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 104
- 主要终点
- The difference in the proportion of mutations of the PIK3CA gene.
研究概览
简要总结
Pain is common in cancer, affecting between 40 and 60% of patients depending on tumour type and stage of disease, and represents a major area of unmet need in cancer survivors. Despite advances in treatment, there has been no significant reduction in those who experience pain. Breast cancer is common. It represents 10% of newly diagnosed cancers globally and is often associated with pain.
Exact physiological mechanisms for cancer pain are not yet fully established. There is a complex relationship between a malignant lesion and its micro-environment; a tumour does not exist in isolation but has a dynamic relationship with host cells. There is a growing interest in delineating the relationship between tumour manifestations and pain.
By retrospectively identifying individuals who have been referred to specialist pain clinics at a cancer centre and matching them to controls, the investigators can identify two groups of patients (those who experienced significant problems with pain and those who did not). Accessing paraffin-embedded tissue samples from those that have had surgical resections, will allow the investigators to compare tissue samples, in particular the metabolic and genetic differences, between the two groups.
No new tissue samples will be required for this study.
Pain is a major area of unmet need in cancer survivors. The investigators propose that this project would provide valuable knowledge and pilot data regarding the link between pain and tumour genetics. It has the potential to identify tumour genes or mutations that are associated with greater incidences of pain and ultimately potentially guide targeted interventions to help reduce the frequency and impact of pain on patients living with and beyond cancer.
详细描述
This study will be a retrospective, case-control study. There will be two groups of patients identified retrospectively:
The first group will be patients who have been referred to the pain management team for persistent-post surgical pain following breast cancer treatment.
The second group, will consist of patients who have been matched for age, procedure and time-lapsed since operation. These patients will not have persistent post-surgical pain.
Archived paraffin-embedded tissue samples, that have previously been taken from these patients, will be required. Samples accessed will be from patients who have previously provided consent for their samples to be used for research purposes. Once appropriate samples have been identified by the tissue banks, all data will be pseudonymised. This will include details that patients have consented to providing for research purposes via the Pain Management Database, which has Trust (CCR 442) and Research Ethics Committee (REC 16/LO/1989) approval.
Laboratory studies will then be conducted to A) investigate the underlying variations of the PIK3CA gene of tumours within the two cohorts of patients, B) investigate other genetic variations between these two groups and C) establish the key genetic and signalling pathway alterations between these two groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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 receiving treatment at the Royal Marsden Hospital.
- •Patients with a diagnosis of primary breast cancer.
- •Patients who have had surgical resection of their breast tumour.
- •Paraffin-embedded tissue samples available from Royal Marsden Tissue Banks.
排除标准
- •Under 18 years of age.
- •Lack of adequate tissue sample available from the Tissue Bank.
结局指标
主要结局
The difference in the proportion of mutations of the PIK3CA gene.
时间窗: Within 6-8months
PIK3CA genomics will result in a binary measure (either wild-type or mutant). The difference in proportion of the PIK3CA gene mutation in those with persistent post-surgical pain compared with those without persistent post-surgical pain will be the primary outcome measure.
次要结局
- Proportion of individual gene mutations in pain group compared with the no pain group.(Within 6-8months)
- Difference in mean gene expression in those with pain compared with those without pain.(Within 6-8months)
- Frequency of changes to DNA copy number (either amplification/gain or loss) in those with pain compared with those without pain.(Within 6-8months)
- Difference in median of magnitude of activation status of signalling pathways between those with pain and those without pain.(Within 6-8months)
- Proportion of individual DNA copy number changes (either amplification/gain or loss) in those with pain compared with those without pain.(Within 6-8months)