Endometrial CancerSPEEDNCT05026073
Vibrational Spectroscopy for Endometrial Cancer Diagnosis
An observational study of Endometrial Cancer and Endometrial Hyperplasia, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Cancer, Endometrial Hyperplasia
- What is being tested?
- Information about clinical risk factors for endometrial cancer and endometrial hyperplasia, Blood and endometrial tissue sampling and Lymph node sampling
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jan 2020to Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- Control group
- Healthy with benign disease, non-malignancy
- Undergoing hysterectomy (any route, e.g. laparoscopy and laparotomy)
Who cannot join
- Patient's refusal / inability to consent
- Synchronous gynaecological cancer (ovary, cervix, fallopian tubes)
- Previous pelvic radiotherapy
- Previous hysterectomy
- Undiagnosed vaginal bleeding
- Previous endometrial ablation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Nottingham University Hospitals NHS Trust
Nottingham, England, NG5 1PB
Roberta Schiemer, MBBS
About this study
Official title: Application of Vibrational Biospectroscopy as a Novel Diagnostic Tool in Endometrial Cancer
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.
Read the detailed 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.
- Conditions
- Endometrial Cancer, Endometrial Hyperplasia
- Being tested
- Information about clinical risk factors for endometrial cancer and endometrial hyperplasia, Blood and endometrial tissue sampling, Lymph node sampling
- Keywords
- endometrial cancer, uterine neoplasm, cancer of the endometrium, Spectroscopy, Raman spectroscopy, Fourier Transform Infrared spectroscopy, endometrial hyperplasia
- Medical subject headings
- Endometrial Neoplasms, Endometrial Hyperplasia, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information about clinical risk factors for endometrial cancer and endometrial hyperplasiaBehavioural
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 samplingProcedure or surgery
- 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 samplingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Endometrial Cancer: | Women with histological diagnosis of cancer of the endometrium (any type) undergoing hysterectomy Receives: Behavioral: Information about clinical risk factors for endometrial cancer and endometrial hyperplasia; Procedure: Blood and endometrial tissue sampling; Procedure: Lymph node sampling | |
| Group 2 Endometrial Hyperplasia: | Women with histological diagnosis of endometrial hyperplasia (with or without atypia) undergoing hysterectomy Receives: Behavioral: Information about clinical risk factors for endometrial cancer and endometrial hyperplasia; Procedure: Blood and endometrial tissue sampling | |
| Group 3 Controls: | Healthy women undergoing hysterectomy for a benign reason Receives: Behavioral: Information about clinical risk factors for endometrial cancer and endometrial hyperplasia; Procedure: Blood and endometrial tissue sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (4)
Discriminating wavenumbers
Identification of the most important wavenumbers that distinguish between normal, hyperplasia and cancer
Measured: Baseline
Sub-analysis of endometrial cancer and hyperplasia sub-types
sub-analysis of segregation percentages for pre-cancerous changes (non-atypical / atypical hyperplasia) and cancer subtypes
Measured: Baseline
Test reliability
Calculation of inter- and intra- user classification variability
Measured: 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)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start19 Jan 2020
- Primary completionAug 2023 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ketankumar Gajjar, MD, Principal investigator, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026073
- Sponsor's protocol ID
- 19ON033
- Acronym
- SPEED
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Vibrational Biospectroscopy as a Novel Diagnostic Tool in Endometrial Cancer
- ClinicalTrials.gov ID
- NCT05026073
- Acronym / sponsor ID
- SPEED / 19ON033
- Conditions
- Endometrial Cancer, Endometrial Hyperplasia
- Keywords
- endometrial cancer, uterine neoplasm, cancer of the endometrium, Spectroscopy, Raman spectroscopy, Fourier Transform Infrared spectroscopy, endometrial hyperplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 19 Jan 2020 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 Endometrial Cancer: | – | Behavioral: Information about clinical risk factors for endometrial cancer and endometrial hyperplasia, Procedure: Blood and endometrial tissue sampling, Procedure: Lymph node samplingWomen with histological diagnosis of cancer of the endometrium (any type) undergoing hysterectomy |
| Group 2 Endometrial Hyperplasia: | – | Behavioral: Information about clinical risk factors for endometrial cancer and endometrial hyperplasia, Procedure: Blood and endometrial tissue samplingWomen with histological diagnosis of endometrial hyperplasia (with or without atypia) undergoing hysterectomy |
| Group 3 Controls: | – | Behavioral: Information about clinical risk factors for endometrial cancer and endometrial hyperplasia, Procedure: Blood and endometrial tissue samplingHealthy women undergoing hysterectomy for a benign reason |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- Endometrial cancer group:
- Endometrial hyperplasia group:
- Control group
Key exclusion criteria (6 listed)
- Patient's refusal / inability to consent
- Synchronous gynaecological cancer (ovary, cervix, fallopian tubes)
- Previous pelvic radiotherapy
- Previous hysterectomy
- Undiagnosed vaginal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information about clinical risk factors for endometrial cancer and endometrial hyperplasiaage, 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. | Behavioural | Group 1 Endometrial Cancer:, Group 2 Endometrial Hyperplasia:, Group 3 Controls: |
| 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 or surgery | Group 1 Endometrial Cancer:, Group 2 Endometrial Hyperplasia:, Group 3 Controls: |
| Lymph node samplingLymph 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. | Procedure or surgery | Group 1 Endometrial Cancer: |
Primary outcome
Vibrational Spectroscopy diagnostic accuracy
Time frame: Baseline
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.
4 secondary outcomes
Discriminating wavenumbers
Time frame: Baseline
Sub-analysis of endometrial cancer and hyperplasia sub-types
Time frame: Baseline
Test reliability
Time frame: Baseline
Multivariate analysis of patient and tumour characteristics
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
Related trials for Endometrial Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ketankumar Gajjar, MD principal investigator
Nottingham University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer and Endometrial Hyperplasia, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberta Schiemer, MBBS (0115 969 1169, roberta.schiemer@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vibrational Spectroscopy diagnostic accuracy (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.