Vibrational Spectroscopy for Endometrial Cancer Diagnosis

Last updated: August 23, 2021
Sponsor: Nottingham University Hospitals NHS Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Endometrial Cancer

Vaginal Cancer

Dysfunctional Uterine Bleeding

Treatment

N/A

Clinical Study ID

NCT05026073
19ON033
  • Ages 18-90
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Endometrial cancer group:
  • Established histopathological diagnosis of cancer of the endometrium (any stageand subtype)
  • Patients must be eligible for primary staging surgery (any route, e.g.laparoscopy and laparotomy)
  1. Endometrial hyperplasia group:
  • Established histopathological diagnosis of endometrial hyperplasia (with orwithout atypia)
  • Treatment with hysterectomy deemed necessary
  1. Control group
  • Healthy with benign disease, non-malignancy
  • Undergoing hysterectomy (any route, e.g. laparoscopy and laparotomy)

Exclusion

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

Study Design

Total Participants: 150
Study Start date:
January 19, 2020
Estimated Completion Date:
November 30, 2024

Study 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.

Connect with a study center

  • Nottingham University Hospitals NHS Trust

    Nottingham, England NG5 1PB
    United Kingdom

    Active - Recruiting

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