Endometrial NeoplasmsMETRODECNCT04867109
HE4 in the Diagnostic Approach of Endometrial Cancer in Patients With Postmenopausal Bleeding
An observational study of Endometrial Neoplasms and Postmenopause, run by Nantes University Hospital at 2 sites in France.
Trial summary
This study aims to explore the sensitivity of an innovative marker, HE4, in the diagnosis approach of endometrial cancer in case of postmenopausal bleedings. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Neoplasms, Postmenopause, Uterine Hemorrhage
- What is being tested?
- Patients with Post menopausal bleeding and CA125 and HE4 assays
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Jun 2021to 1 Sep 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Any patient with postmenopausal bleeding who is to undergo hysteroscopy or hysterectomy will have an additional blood tube taken during her pre-operative blood work-up for the measurement of the serum markers HE4 and CA125 after she has indicated that she does not wish to participate in the study
Who may be able to join
- Patient with postmenopausal bleeding
- Patient requiring hysteroscopy or hysterectomy
- No objection from the patient to participate in the study
Who cannot join
- Non-menopausal patient
- Patient under guardianship, curatorship or deprived of her freedom
- Patient with proven metastases on imaging
- Patient with a macroscopically suspicious cervix
- Patient presenting an ovarian cyst or an associated adnexal pathology
- Patient contraindicated for surgical treatment (therefore not eligible for pathological analysis)
- Patient who has already been treated with hormone therapy for breast cancer
- Patient who has already had surgery for this pathology, with a contributing anatomopathological result (we will therefore include patients who would not benefit from an operative hysteroscopy after performing a cornier® pipelle that does not allow a positive result)
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Vendee Hospital Center
La Roche-sur-Yon, Vendee, 85925
Guillaume DUCARME, MD
- Recruiting
Saint-Nazaire Hospital
Saint-Nazaire, Loire-Atlantique, 44606
Mélanie RANDET, MD
About this study
Official title: Multicenter Prospective Study Evaluating the Interest of HE4 in the Diagnostic Approach of Endometrial Cancer in Patients With Postmenopausal Bleeding
This study aims to explore the sensitivity of an innovative marker, HE4, in the diagnosis approach of endometrial cancer in case of postmenopausal bleedings.
Read the detailed description
Endometrial cancer is the most common pelvic gynecological cancer in France, ranking 5th among cancers in women in terms of incidence.
The most frequent symptom is post-menopausal bleeding and is one of the primary reasons for consultation in gynecological emergencies.
The diagnosis of endometrial cancer is made by histological analysis of endometrial tissue taken during a surgical intervention. The latter is mostly reassuring.
These interventions are often performed in mild situations and there is currently no element to be sufficiently reassuring to avoid surgery.
At present, there is no biological marker used in current practice. In the population of patients with post-menopausal bleeding requiring surgical exploration for diagnosis, the pathology results are often reassuring. These procedures could have been avoided, especially as these patients often have numerous co-morbidities and these surgeries are therefore more risky. The appearance of a new tumour marker could be useful in the management of these patients and avoid many unnecessary and risky surgeries
This study aims to explore the sensitivity of an innovative marker, HE4, in the diagnosis approach of endometrial cancer in case of postmenopausal bleedings.
- Conditions
- Endometrial Neoplasms, Postmenopause, Uterine Hemorrhage, Cancer Biomarker, CA 125 Antigen
- Being tested
- Patients with Post menopausal bleeding, CA125 and HE4 assays
- Keywords
- Endometrial cancer, Human epididymis protein 4, HE4, CA125, Post-menopausal bleeding
- Medical subject headings
- Endometrial Neoplasms, Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with Post menopausal bleedingOther
Any patient presenting post-menopausal bleeding who is to undergo hysteroscopy or hysterectomy will have an additional blood tube taken during her pre-operative blood work-up for the determination of the serum markers HE4 and CA125, after having obtained her non-opposition to participate in the study.
The blood tube collected for the research will be sent to the biochemistry laboratory of the Nantes University Hospital for a centralized analysis.
This analysis will be done sequentially and the results will not be transmitted to the investigator.
At D0, the day of surgery, the operative report will be retrieved as well as the quality of life questionnaires SF12 and PGI-I and the acceptability questionnaire completed before surgery.
At 1 month after surgery, the anatomopathological results will be retrieved as well as the value of the tumour markers CA125 and HE4.
CA125 and HE4 assaysDiagnostic test
Blood was collected in a standard heparinized vial. Samples were sent to a central laboratory unit (biochemistry laboratory at the Nantes university hospital), centrifuged and plasmas were stored at -20°C until analysis. Plasma CA125 and HE4 concentrations were determined by run in single measurements using an electrochemiluminescence Elecsys immunoassay (ECLIA) on a Roche Diagnostics Cobas 8000® e602 analyser (Roche Diagnostics, Mannheim, Germany).
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the sensitivity of the HE4 marker in patients with postmenopausal bleeding in the diagnosis of endometrial cancer
The HE4 assays will be performed using the electrochemiluminescence (ECL) technique on Cobas Pro module E801, Roche Diagnostics. The HE4 assay is based on a sandwich-type electrochemiluminescence method. The HE4 assay with the Roche Diagnostics Elecsys reagent has been standardized against the Fujirebo Diagnostics HE4 EIA method.
Positive/negative HE4 result for the estimation of the sensitivity of HE4 in the diagnosis of endometrial cancer.
The commonly accepted threshold for ovarian cancer management of 140pmol/l in postmenopausal patients should be used.
The gold standard for endometrial cancer is the pathological result (absence/presence of cancer) of the sample taken.
Measured: Until the pathological results (About 10-15 days)
Secondary outcomes (8)
Assess other diagnostic parameters (specificity, PPV, NPV) of HE4
ROC curve for the HE4 marker in the diagnosis of endometrial cancer.
Measured: Until the pathological results (About 10-15 days)
Establish the optimal threshold of HE4 for the diagnosis of endometrial cancer (use of an ROC curve)
Search for the threshold with the best specificity of HE4 in the diagnosis of endometrial cancer
Measured: Until the pathological results (About 10-15 days)
Evaluate the diagnostic capabilities of CA125 alone and in combination with HE4, as well as the REM and REM-B algorithms for the diagnosis of endometrial cancer
Estimation of sensitivity, specificity, PPV and NPV in the diagnosis of endometrial cancer for the CA125 biomarker and the REM and REM B algorithms
Measured: Until the pathological results (About 10-15 days)
Establish the existence of thresholds for HE4 and/or CA125 markers predictive of disease severity (FIGO stage)
Search for HE4 and CA125 marker thresholds to assess disease severity by FIGO stage
Measured: Until the results of the extension assessment in the event of proven endometrial cancer (1 month)
Reassess the pathological threshold value of endometrial thickness on ultrasound
Search for the pathological threshold of endometrial thickness in the diagnosis of endometrial cancer
Measured: Until the pathological results (About 10-15 days)
Assess the relationship between endometrial thickness on ultrasound and HE4 and CA125 marker values
Estimation of the relationship between CA125 and HE4 markers and endometrial thickness on ultrasound
Measured: Until the pathological results (About 10-15 days)
To evaluate the diagnostic capabilities of HE4 and CA125 in subgroups of smoking patients and patients with renal failure
Estimation of sensitivity, specificity, PPV and NPV in the diagnosis of endometrial cancer for HE4 and CA125 in patients with active smoking and/or renal failure
Measured: Until the pathological results (About 10-15 days)
Identify potential confounding factors associated with the value of the HE4 marker like treatments, comorbidities (renal insufficiency, high BMI) and others criteria that are collected in the medical files
Analyses of variables measured at inclusion that may influence the value of the HE4 marker.
Measured: Until the pathological results (About 10-15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start25 Jun 2021
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial NeoplasmsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867109
- Sponsor's protocol ID
- RC21_0166
- Acronym
- METRODEC
- Status last verified
- Sep 2021
- First submitted
- 13 Apr 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Study Evaluating the Interest of HE4 in the Diagnostic Approach of Endometrial Cancer in Patients With Postmenopausal Bleeding
- ClinicalTrials.gov ID
- NCT04867109
- Acronym / sponsor ID
- METRODEC / RC21_0166
- Conditions
- Endometrial Neoplasms, Postmenopause, Uterine Hemorrhage, Cancer Biomarker, CA 125 Antigen
- Keywords
- Endometrial cancer, Human epididymis protein 4, HE4, CA125, Post-menopausal bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 30 Apr 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.
This study aims to explore the sensitivity of an innovative marker, HE4, in the diagnosis approach of endometrial cancer in case of postmenopausal bleedings.
Detailed description
Endometrial cancer is the most common pelvic gynecological cancer in France, ranking 5th among cancers in women in terms of incidence.
The most frequent symptom is post-menopausal bleeding and is one of the primary reasons for consultation in gynecological emergencies.
The diagnosis of endometrial cancer is made by histological analysis of endometrial tissue taken during a surgical intervention. The latter is mostly reassuring.
These interventions are often performed in mild situations and there is currently no element to be sufficiently reassuring to avoid surgery.
At present, there is no biological marker used in current practice. In the population of patients with post-menopausal bleeding requiring surgical exploration for diagnosis, the pathology results are often reassuring. These procedures could have been avoided, especially as these patients often have numerous co-morbidities and these surgeries are therefore more risky. The appearance of a new tumour marker could be useful in the management of these patients and avoid many unnecessary and risky surgeries
This study aims to explore the sensitivity of an innovative marker, HE4, in the diagnosis approach of endometrial cancer in case of postmenopausal bleedings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient with postmenopausal bleeding who is to undergo hysteroscopy or hysterectomy will have an additional blood tube taken during her pre-operative blood work-up for the measurement of the serum markers HE4 and CA125 after she has indicated that she does not wish to participate in the study
Key inclusion criteria (3 listed)
- Patient with postmenopausal bleeding
- Patient requiring hysteroscopy or hysterectomy
- No objection from the patient to participate in the study
Key exclusion criteria (8 listed)
- Non-menopausal patient
- Patient under guardianship, curatorship or deprived of her freedom
- Patient with proven metastases on imaging
- Patient with a macroscopically suspicious cervix
- Patient presenting an ovarian cyst or an associated adnexal pathology
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 |
|---|---|---|
| Patients with Post menopausal bleedingAny patient presenting post-menopausal bleeding who is to undergo hysteroscopy or hysterectomy will have an additional blood tube taken during her pre-operative blood work-up for the determination of the serum markers HE4 and CA125, after having obtained her non-opposition to participate in the study. The blood tube collected for the research will be sent to the biochemistry laboratory of the Nantes University Hospital for a centralized analysis. This analysis will be done sequentially and the results will not be transmitted to the investigator. At D0, the day of surgery, the operative report will be retrieved as well as the quality of life questionnaires SF12 and PGI-I and the acceptability questionnaire completed before surgery. At 1 month after surgery, the anatomopathological results will be retrieved as well as the value of the tumour markers CA125 and HE4. | Other | – |
| CA125 and HE4 assaysBlood was collected in a standard heparinized vial. Samples were sent to a central laboratory unit (biochemistry laboratory at the Nantes university hospital), centrifuged and plasmas were stored at -20°C until analysis. Plasma CA125 and HE4 concentrations were determined by run in single measurements using an electrochemiluminescence Elecsys immunoassay (ECLIA) on a Roche Diagnostics Cobas 8000® e602 analyser (Roche Diagnostics, Mannheim, Germany). | Diagnostic test | – |
Primary outcome
To evaluate the sensitivity of the HE4 marker in patients with postmenopausal bleeding in the diagnosis of endometrial cancer
Time frame: Until the pathological results (About 10-15 days)
The HE4 assays will be performed using the electrochemiluminescence (ECL) technique on Cobas Pro module E801, Roche Diagnostics. The HE4 assay is based on a sandwich-type electrochemiluminescence method. The HE4 assay with the Roche Diagnostics Elecsys reagent has been standardized against the Fujirebo Diagnostics HE4 EIA method. Positive/negative HE4 result for the estimation of the sensitivity of HE4 in the diagnosis of endometrial cancer. The commonly accepted threshold for ovarian cancer management of 140pmol/l in postmenopausal patients should be used. The gold standard for endometrial cancer is the pathological result (absence/presence of cancer) of the sample taken.
8 secondary outcomes
Assess other diagnostic parameters (specificity, PPV, NPV) of HE4
Time frame: Until the pathological results (About 10-15 days)
Establish the optimal threshold of HE4 for the diagnosis of endometrial cancer (use of an ROC curve)
Time frame: Until the pathological results (About 10-15 days)
Evaluate the diagnostic capabilities of CA125 alone and in combination with HE4, as well as the REM and REM-B algorithms for the diagnosis of endometrial cancer
Time frame: Until the pathological results (About 10-15 days)
Establish the existence of thresholds for HE4 and/or CA125 markers predictive of disease severity (FIGO stage)
Time frame: Until the results of the extension assessment in the event of proven endometrial cancer (1 month)
Reassess the pathological threshold value of endometrial thickness on ultrasound
Time frame: Until the pathological results (About 10-15 days)
Assess the relationship between endometrial thickness on ultrasound and HE4 and CA125 marker values
Time frame: Until the pathological results (About 10-15 days)
To evaluate the diagnostic capabilities of HE4 and CA125 in subgroups of smoking patients and patients with renal failure
Time frame: Until the pathological results (About 10-15 days)
Identify potential confounding factors associated with the value of the HE4 marker like treatments, comorbidities (renal insufficiency, high BMI) and others criteria that are collected in the medical files
Time frame: Until the pathological results (About 10-15 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Neoplasms and Postmenopause, run by Nantes University Hospital at 2 sites in France.
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 3 inclusion and 8 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 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 Vincent DOCHEZ, MD (33 2 40 08 78 00, vincent.dochez@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the sensitivity of the HE4 marker in patients with postmenopausal bleeding in the diagnosis of endometrial cancer (time frame: Until the pathological results (About 10-15 days)). 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 17 Sep 2021.