NCT05026073

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

3.5 years

First QC Date

August 23, 2021

Last Update Submit

August 23, 2021

Conditions

Endometrial CancerEndometrial Hyperplasia

Keywords

endometrial canceruterine neoplasmcancer of the endometriumSpectroscopyRaman spectroscopyFourier Transform Infrared spectroscopyendometrial hyperplasia

Outcome Measures

Primary Outcomes (1)

  • Vibrational Spectroscopy diagnostic accuracy

    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.

    Baseline

Secondary Outcomes (4)

  • Discriminating wavenumbers

    Baseline

  • Sub-analysis of endometrial cancer and hyperplasia sub-types

    Baseline

  • Test reliability

    Baseline

  • Multivariate analysis of patient and tumour characteristics

    Baseline

Study Arms (3)

Group 1 Endometrial Cancer:

Women with histological diagnosis of cancer of the endometrium (any type) undergoing hysterectomy

Behavioral: Information about clinical risk factors for endometrial cancer and endometrial hyperplasiaProcedure: Blood and endometrial tissue samplingProcedure: Lymph node sampling

Group 2 Endometrial Hyperplasia:

Women with histological diagnosis of endometrial hyperplasia (with or without atypia) undergoing hysterectomy

Behavioral: Information about clinical risk factors for endometrial cancer and endometrial hyperplasiaProcedure: Blood and endometrial tissue sampling

Group 3 Controls:

Healthy women undergoing hysterectomy for a benign reason

Behavioral: Information about clinical risk factors for endometrial cancer and endometrial hyperplasiaProcedure: Blood and endometrial tissue sampling

Interventions

Information about clinical risk factors for endometrial cancer and endometrial hyperplasiaBEHAVIORAL

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.

Group 1 Endometrial Cancer:Group 2 Endometrial Hyperplasia:Group 3 Controls:
Blood and endometrial tissue samplingPROCEDURE

* 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.

Group 1 Endometrial Cancer:Group 2 Endometrial Hyperplasia:Group 3 Controls:
Lymph node samplingPROCEDURE

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.

Group 1 Endometrial Cancer:

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Specimens will be retained for the duration of the study

MeSH Terms

Conditions

Endometrial NeoplasmsEndometrial HyperplasiaUterine Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Ketankumar Gajjar, MD

    Nottingham University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberta Schiemer, MBBS

CONTACT

0115 969 1169roberta.schiemer@nottingham.ac.uk

Ketankumar Gajjar, MD

CONTACT

0115 969 1169ketankumar.gajjar@nuh.nhs.uk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2021

First Posted

August 30, 2021

Study Start

January 19, 2020

Primary Completion

August 1, 2023

Study Completion

November 1, 2024

Last Updated

August 30, 2021

Record last verified: 2021-08

Locations

GB(1)