Application of Vibrational Biospectroscopy as a Novel Diagnostic Tool in Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Vibrational Spectroscopy diagnostic accuracy
研究概览
简要总结
The purpose of this study is to investigate the ability of vibrational spectroscopic techniques, Raman spectroscopy and Attenuated Total Reflection - Fourier Transform Infrared spectroscopy (ATR-FTIR), to accurately differentiate endometrial tissue, lymph nodes and blood samples with womb cancer or endometrial hyperplasia from healthy controls.
详细描述
Womb cancer is the sixth most common cancer in women, with rising incidence worldwide. Current diagnostic strategies are time consuming, invasive and have limited accuracy, furthermore there is no population-wide screening. Treatment depends on patients' health, type of disease and spread at the time of diagnosis. Most women will be offered surgery, however the role of lymph node dissection in early stage disease remains controversial.
There is therefore a need for an objective, accurate test, able to detect pre-cancer and cancer early and able to identify metastatic node involvement, so that lymph node excision is performed only when necessary.
Attenuated Total Reflection - Fourier Transform Infrared (ATR-FTIR) spectroscopy and Raman spectroscopy are non-invasive, objective techniques that use the interaction of light within tissues to gain detailed information about the chemical composition of biological samples. These methods have shown tremendous potential for improving diagnosis and treatment of cancer.
This study aims to use Vibrational Spectroscopy to examine blood plasma and serum, endometrial biopsies via Pipelle device and pelvic/para-aortic lymph nodes for the presence of endometrial pre-cancer and cancer changes. The analyses will be performed on fresh (wet) as well as dried samples.
The ultimate goal is to develop a point-of-care test and an intra-operative tool for endometrial cancer screening and diagnosis. Such a test could speed up endometrial cancer diagnosis, reduce treatment delays and individualise patients care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Endometrial cancer group:
- •Established histopathological diagnosis of cancer of the endometrium (any stage and subtype)
- •Patients must be eligible for primary staging surgery (any route, e.g. laparoscopy and laparotomy)
- •Endometrial hyperplasia group:
- •Established histopathological diagnosis of endometrial hyperplasia (with or without atypia)
- •Treatment with hysterectomy deemed necessary
- •Control group
- •Healthy with benign disease, non-malignancy
- •Undergoing hysterectomy (any route, e.g. laparoscopy and laparotomy)
排除标准
- •Patient's refusal / inability to consent
- •Synchronous gynaecological cancer (ovary, cervix, fallopian tubes)
- •Previous pelvic radiotherapy
- •Previous hysterectomy
- •Undiagnosed vaginal bleeding
- •Previous endometrial ablation
结局指标
主要结局
Vibrational Spectroscopy diagnostic accuracy
时间窗: Baseline
The primary outcome of the study will be to evaluate the correct classification of cases of endometrial cancer, endometrial hyperplasia and controls by Raman and ATR-FTIR spectral analysis, compared to histopathology as the standard of reference. The outcome will be measured with sensitivity, specificity, positive/negative predictive values and likelihood ratios. The diagnostic accuracy will be documented for pipelle samples, endometrial samples from hysterectomy specimens, pelvic/para-aortic lymph nodes, blood serum and plasma.
次要结局
- Discriminating wavenumbers(Baseline)
- Sub-analysis of endometrial cancer and hyperplasia sub-types(Baseline)
- Test reliability(Baseline)
- Multivariate analysis of patient and tumour characteristics(Baseline)