Vibrational Spectroscopy for Endometrial Cancer Diagnosis
NCT ID: NCT05026073
Last Updated: 2021-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2020-01-19
2024-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group 1 Endometrial Cancer:
Women with histological diagnosis of cancer of the endometrium (any type) undergoing hysterectomy
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.
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.
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.
Group 2 Endometrial Hyperplasia:
Women with histological diagnosis of endometrial hyperplasia (with or without atypia) undergoing hysterectomy
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.
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.
Group 3 Controls:
Healthy women undergoing hysterectomy for a benign reason
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Synchronous gynaecological cancer (ovary, cervix, fallopian tubes)
* Previous pelvic radiotherapy
* Previous hysterectomy
* Undiagnosed vaginal bleeding
* Previous endometrial ablation
18 Years
90 Years
FEMALE
Yes
Sponsors
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Nottingham University Hospitals NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Ketankumar Gajjar, MD
Role: PRINCIPAL_INVESTIGATOR
Nottingham University Hospitals NHS Trust
Locations
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Nottingham University Hospitals NHS Trust
Nottingham, England, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Roberta Schiemer, MBBS
Role: primary
Other Identifiers
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19ON033
Identifier Type: -
Identifier Source: org_study_id
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