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Vibrational Spectroscopy for Endometrial Cancer Diagnosis

NCT05026073 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2021-08-30

No results posted yet for this 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.

Conditions

Interventions

BEHAVIORAL

Information about clinical risk factors for endometrial cancer and endometrial hyperplasia

age, race, parity, body mass index, last menstrual period, menstrual cycle type, hypertension, type II diabetes, anovulation, polycystic ovary syndrome, indication for hysterectomy and smoking history. Other epidemiologic risk factors including tamoxifen exposure, history of breast cancer, current hormone therapy use, anticoagulant use, oral contraception use, family history of endometrial, breast or colon cancer.

PROCEDURE

Blood and endometrial tissue sampling

* All women will undergo planned hysterectomy. * Venous blood sample will be collected prior to surgery. * Endometrial sampling via Pipelle device will be performed immediately prior to hysterectomy * Endometrial biopsy from the hysterectomy specimen will be obtained under direct vision The plasma and serum obtained from the blood samples will be analysed with ATR-FTIR and Raman spectroscopes. Spectra from both wet and dry specimens will be recorded. All tissue samples retrieved will be placed in Phosphate Buffered Solution for transfer to the histopathology laboratory. Spectra will be collected from the fresh samples with ATR-FTIR and Raman spectroscopes. Spectral analyses will subsequently be repeated on dry samples post fixation and processing. All tissue samples will undergo haematoxylin and eosin staining after spectral analysis for standard histopathological confirmation.

PROCEDURE

Lymph node sampling

Lymph nodes will be excised if recommended as part of the standard treatment for endometrial cancer. Each node will be cut in half or in quarters, depending on size, to expose the core. Wet and dry spectral analysis will be performed, followed by staining for histopathological confirmation.

Sponsors & Collaborators

  • Nottingham University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Ketankumar Gajjar, MD · Nottingham University Hospitals NHS Trust

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-19
Primary Completion
2023-08-31
Completion
2024-11-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05026073 on ClinicalTrials.gov