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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Endometrial Cancer: | Women with histological diagnosis of cancer of the endometrium (any type) undergoing hysterectomy |
| |
| Group 2 Endometrial Hyperplasia: | Women with histological diagnosis of endometrial hyperplasia (with or without atypia) undergoing hysterectomy |
| |
| Group 3 Controls: | Healthy women undergoing hysterectomy for a benign reason |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Information about clinical risk factors for endometrial cancer and endometrial hyperplasia | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Discriminating wavenumbers | Identification of the most important wavenumbers that distinguish between normal, hyperplasia and cancer | Baseline |
| Sub-analysis of endometrial cancer and hyperplasia sub-types |
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Inclusion Criteria:
Endometrial cancer group:
Endometrial hyperplasia group:
Control group
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberta Schiemer, MBBS | Contact | 0115 969 1169 | roberta.schiemer@nottingham.ac.uk | |
| Ketankumar Gajjar, MD | Contact | 0115 969 1169 | ketankumar.gajjar@nuh.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Ketankumar Gajjar, MD | Nottingham University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottingham University Hospitals NHS Trust | Recruiting | Nottingham | England | NG5 1PB | United Kingdom |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D004714 | Endometrial Hyperplasia |
| D014594 | Uterine Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Specimens will be retained for the duration of the study
|
| Blood and endometrial tissue sampling | Procedure |
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 | Procedure | 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. |
|
sub-analysis of segregation percentages for pre-cancerous changes (non-atypical / atypical hyperplasia) and cancer subtypes
| Baseline |
| Test reliability | Calculation of inter- and intra- user classification variability | Baseline |
| Multivariate analysis of patient and tumour characteristics | Multivariate analysis of variance will be calculated to account for factors potentially affecting test performance (histological subtype, menopausal status, age, co-morbidities, hormonal treatment) | Baseline |
| D014591 |
| Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |