Clinical trial NCT05026073: Vibrational Spectroscopy for Endometrial Cancer Diagnosis
Official title: Application of Vibrational Biospectroscopy as a Novel Diagnostic Tool in Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Cancer
Endometrial Hyperplasia
Keywords: endometrial cancer
uterine neoplasm
cancer of the endometrium
Spectroscopy
Raman spectroscopy
Fourier Transform Infrared spectroscopy
endometrial hyperplasia
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing hysterectomy with a histological diagnosis of primary cancer of the endometrium (irrespective of subtype), or endometrial hyperplasia (with or without atypia) and women undergoing hysterectomy for a benign indication.

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.

Eligibility criteria: Inclusion Criteria:

1. 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)
2. Endometrial hyperplasia group:

   * Established histopathological diagnosis of endometrial hyperplasia (with or without atypia)
   * Treatment with hysterectomy deemed necessary
3. Control group

   * Healthy with benign disease, non-malignancy
   * Undergoing hysterectomy (any route, e.g. laparoscopy and laparotomy)

Exclusion Criteria:

* Patient's refusal / inability to consent
* Synchronous gynaecological cancer (ovary, cervix, fallopian tubes)
* Previous pelvic radiotherapy
* Previous hysterectomy
* Undiagnosed vaginal bleeding
* Previous endometrial ablation

Primary outcomes:
measure: Vibrational Spectroscopy diagnostic accuracy
timeFrame: Baseline
Secondary outcomes:
measure: Discriminating wavenumbers
timeFrame: Baseline
measure: Sub-analysis of endometrial cancer and hyperplasia sub-types
timeFrame: Baseline
measure: Test reliability
timeFrame: Baseline
measure: Multivariate analysis of patient and tumour characteristics
timeFrame: Baseline
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
state: England
Study officials:
affiliation: Nottingham University Hospitals NHS Trust
name: Ketankumar Gajjar, MD
role: PRINCIPAL_INVESTIGATOR
References: