Vibrational Spectroscopy for Endometrial Cancer Diagnosis
- Conditions
- Endometrial CancerEndometrial Hyperplasia
- Interventions
- Behavioral: Information about clinical risk factors for endometrial cancer and endometrial hyperplasiaProcedure: Blood and endometrial tissue samplingProcedure: Lymph node sampling
- Registration Number
- NCT05026073
- Lead Sponsor
- Nottingham University Hospitals NHS Trust
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 150
-
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)
- Patient's refusal / inability to consent
- Synchronous gynaecological cancer (ovary, cervix, fallopian tubes)
- Previous pelvic radiotherapy
- Previous hysterectomy
- Undiagnosed vaginal bleeding
- Previous endometrial ablation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 2 Endometrial Hyperplasia: Information about clinical risk factors for endometrial cancer and endometrial hyperplasia Women with histological diagnosis of endometrial hyperplasia (with or without atypia) undergoing hysterectomy Group 1 Endometrial Cancer: Information about clinical risk factors for endometrial cancer and endometrial hyperplasia Women with histological diagnosis of cancer of the endometrium (any type) undergoing hysterectomy Group 1 Endometrial Cancer: Lymph node sampling Women with histological diagnosis of cancer of the endometrium (any type) undergoing hysterectomy Group 3 Controls: Information about clinical risk factors for endometrial cancer and endometrial hyperplasia Healthy women undergoing hysterectomy for a benign reason Group 1 Endometrial Cancer: Blood and endometrial tissue sampling Women with histological diagnosis of cancer of the endometrium (any type) undergoing hysterectomy Group 2 Endometrial Hyperplasia: Blood and endometrial tissue sampling Women with histological diagnosis of endometrial hyperplasia (with or without atypia) undergoing hysterectomy Group 3 Controls: Blood and endometrial tissue sampling Healthy women undergoing hysterectomy for a benign reason
- Primary Outcome Measures
Name Time Method Vibrational Spectroscopy diagnostic accuracy 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.
- Secondary Outcome Measures
Name Time Method Discriminating wavenumbers Baseline Identification of the most important wavenumbers that distinguish between normal, hyperplasia and cancer
Sub-analysis of endometrial cancer and hyperplasia sub-types Baseline sub-analysis of segregation percentages for pre-cancerous changes (non-atypical / atypical hyperplasia) and cancer subtypes
Test reliability Baseline Calculation of inter- and intra- user classification variability
Multivariate analysis of patient and tumour characteristics Baseline Multivariate analysis of variance will be calculated to account for factors potentially affecting test performance (histological subtype, menopausal status, age, co-morbidities, hormonal treatment)
Trial Locations
- Locations (1)
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, England, United Kingdom