Endometrial Carcinoma (EC)NCT06893861
Assessment of the Effectiveness of the Metabolomic Approach in Screening for Endometrial Cancer
An observational study of Endometrial Carcinoma (EC), run by National Cancer Institute, Naples at 1 site in Italy.
Trial summary
The study involves the use of reagents or materials for diagnostic assessments that are not commercially available, specifically a metabolomic signature for screening endometrial carcinoma and/or other types of cancers, and follows a case-control design. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Carcinoma (EC)
- What is being tested?
- Metabolomic profiling
- How many people
- 3,100 participants
- Where
- 1 siteItaly
- Study dates
- 6 Jul 2023to Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The project involves the recruitment of separate cohorts of subjects for the development phase of the metabolomic signature: 1. Women with endometrial carcinoma (n=50); 2. A corresponding cohort of healthy subjects to be used as controls (n=50); 3. Women with other non-oncological uterine conditions and oncological conditions affecting other organs (n=200); 4. An additional cohort will be recruited to validate the trained models (n=2800). This cohort will consist of postmenopausal women, aged between 50 and 80 years.
Who may be able to join
- Female sex
- Age between 50 and 80 years
- Willingness to participate in the study and signing of the informed consent
- Clinical condition of post-menopause
Who cannot join
- Previous hysterectomy
- Hormone replacement therapy
- Immunosuppressive therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Nazionale Tumori | "Fondazione Pascale"
Naples, 80131
Antonella De Luca, 08117770603, a.deluca@istitutotumori.na.it
About this study
The study involves the use of reagents or materials for diagnostic assessments that are not commercially available, specifically a metabolomic signature for screening endometrial carcinoma and/or other types of cancers, and follows a case-control design.
This study aims to achieve several objectives that contribute to evaluating the diagnostic potential of a specific "metabolomic signature" to be used for screening endometrial carcinoma. Specifically, the study seeks to assess the signature's discriminative ability in differentiating between benign endometrial neoplasms and neoplasms of different histological origins.
Read the detailed description
The study is structured into several phases, described below:
- Recruitment and data collection of patients selected for model training at IRCCS Pascale The study will be conducted on patients attending the IRCCS G. Pascale according to normal clinical practice. The patient's participation in the study will begin with the collection of their data and biological samples and will end with the follow-up visit.
- Recruitment and data collection of patients selected for the validation of the trained models at Diagnostica Medica.
This phase of the study will be conducted on patients who will attend the laboratories of the company "Dott.ri Armando and Pierpaolo Cavallo - Diagnostica Medica" according to standard diagnostic and healthcare practices. Specifically, patients who undergo the required checks within the normal diagnostic and healthcare pathway through laboratory medicine, and who meet the enrollment criteria, will be invited to participate in the study.
- Collection of biological samples from enrolled patients In the event of the patient's actual enrollment in the study, blood samples necessary for the study will be collected.
- Analysis of Biological Samples The analysis will consist of both a bioanalytical and a bioinformatic phase. The bioanalytical phase will involve the extraction of the metabolome from DBS (Dried Blood Spots) using a mixture of solvents optimized to extract both polar and apolar metabolites, as well as those with acidic, basic, and neutral properties. This will be followed by a purification phase of the extracted metabolites using liquid-phase partitioning and a post-lyophilization derivatization phase to enhance chromatographic separation. The definition of the metabolomic profile will be carried out using mass spectrometry techniques with a single quadrupole coupled with gas chromatography (GCMS) and high-resolution mass spectrometry techniques (UPLC-Q-Orbitrap).
- Measurement Methods for Results The results of the experiment will be evaluated in terms of sensitivity (defined as the ability to correctly identify affected subjects), specificity (defined as the ability to correctly identify subjects not affected by endometrial carcinoma), positive and negative predictive value (defined respectively as the probability of a subject being correctly classified as affected or not affected), and overall accuracy (defined as the total number of diagnostic errors made by the test). Preliminary evaluations of the diagnostic effectiveness of the metabolomic signature, measured by cross-validation estimates of classification models, showed sensitivity ranging from 93-100%, specificity ranging from 92-98%, and overall accuracy between 95-100%.
The study is expected to last a total of 2 years. All collected data will be integrated and analyzed using mathematical and statistical tools, both descriptive and multivariate.
- Conditions
- Endometrial Carcinoma (EC)
- Being tested
- Metabolomic profiling
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolomic profilingOther
Blood samples will be collected from these subjects, and following metabolomic profiling, the data will provide the foundation for training machine learning models capable of recognizing the metabolomic profiles of subjects with endometrial carcinoma and differentiating them from subjects with other conditions.
| Study group | Role | What they receive |
|---|---|---|
| Cohort of women with endometrial carcinoma | Not described Receives: Other: Metabolomic profiling | |
| Cohort of healthy subjects to be used as controls | Not described Receives: Other: Metabolomic profiling | |
| Cohort of other non-oncological uterine conditions and oncological conditions affecting other organ | Not described Receives: Other: Metabolomic profiling | |
| Additional cohort will be recruited to validate the trained models | This cohort will consist of postmenopausal women, aged between 50 and 80 years. Receives: Other: Metabolomic profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation and Testing of a Metabolomic Signature for Endometrial Carcinoma Screening
Measured: 24 months
Evaluation of the Ability of the Metabolomic Signature to Discriminate Between Neoplasms of Different Histological Origins
Measured: 24 months
Validation of the Developed Model in a Real-World Clinical Setting
Measured: 24 months
Secondary outcomes (2)
Creation of a Predictive Signature for Therapy Response in Endometrial Carcinoma
Measured: 24 months
Creation and Testing of Metabolomic Signatures for Screening Other Neoplastic Conditions (Breast Cancer, Colorectal Cancer, etc.)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start6 Jul 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial Carcinoma (EC)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonella De Luca, Principal investigator, IRCCS I.N.T. "G. Pascale"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893861
- Sponsor's protocol ID
- METABOLOMIC ENDOMETRIO
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of the Metabolomic Approach in Screening for Endometrial Cancer
- ClinicalTrials.gov ID
- NCT06893861
- Acronym / sponsor ID
- METABOLOMIC ENDOMETRIO
- Conditions
- Endometrial Carcinoma (EC)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,100 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 25 Mar 2025 (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 study involves the use of reagents or materials for diagnostic assessments that are not commercially available, specifically a metabolomic signature for screening endometrial carcinoma and/or other types of cancers, and follows a case-control design.
This study aims to achieve several objectives that contribute to evaluating the diagnostic potential of a specific "metabolomic signature" to be used for screening endometrial carcinoma. Specifically, the study seeks to assess the signature's discriminative ability in differentiating between benign endometrial neoplasms and neoplasms of different histological origins.
Detailed description
The study is structured into several phases, described below:
- Recruitment and data collection of patients selected for model training at IRCCS Pascale The study will be conducted on patients attending the IRCCS G. Pascale according to normal clinical practice. The patient's participation in the study will begin with the collection of their data and biological samples and will end with the follow-up visit.
- Recruitment and data collection of patients selected for the validation of the trained models at Diagnostica Medica.
This phase of the study will be conducted on patients who will attend the laboratories of the company "Dott.ri Armando and Pierpaolo Cavallo - Diagnostica Medica" according to standard diagnostic and healthcare practices. Specifically, patients who undergo the required checks within the normal diagnostic and healthcare pathway through laboratory medicine, and who meet the enrollment criteria, will be invited to participate in the study.
- Collection of biological samples from enrolled patients In the event of the patient's actual enrollment in the study, blood samples necessary for the study will be collected.
- Analysis of Biological Samples The analysis will consist of both a bioanalytical and a bioinformatic phase. The bioanalytical phase will involve the extraction of the metabolome from DBS (Dried Blood Spots) using a mixture of solvents optimized to extract both polar and apolar metabolites, as well as those with acidic, basic, and neutral properties. This will be followed by a purification phase of the extracted metabolites using liquid-phase partitioning and a post-lyophilization derivatization phase to enhance chromatographic separation. The definition of the metabolomic profile will be carried out using mass spectrometry techniques with a single quadrupole coupled with gas chromatography (GCMS) and high-resolution mass spectrometry techniques (UPLC-Q-Orbitrap).
- Measurement Methods for Results The results of the experiment will be evaluated in terms of sensitivity (defined as the ability to correctly identify affected subjects), specificity (defined as the ability to correctly identify subjects not affected by endometrial carcinoma), positive and negative predictive value (defined respectively as the probability of a subject being correctly classified as affected or not affected), and overall accuracy (defined as the total number of diagnostic errors made by the test). Preliminary evaluations of the diagnostic effectiveness of the metabolomic signature, measured by cross-validation estimates of classification models, showed sensitivity ranging from 93-100%, specificity ranging from 92-98%, and overall accuracy between 95-100%.
The study is expected to last a total of 2 years. All collected data will be integrated and analyzed using mathematical and statistical tools, both descriptive and multivariate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort of women with endometrial carcinoma | – | Other: Metabolomic profiling |
| Cohort of healthy subjects to be used as controls | – | Other: Metabolomic profiling |
| Cohort of other non-oncological uterine conditions and oncological conditions affecting other organ | – | Other: Metabolomic profiling |
| Additional cohort will be recruited to validate the trained models | – | Other: Metabolomic profilingThis cohort will consist of postmenopausal women, aged between 50 and 80 years. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The project involves the recruitment of separate cohorts of subjects for the development phase of the metabolomic signature: 1. Women with endometrial carcinoma (n=50); 2. A corresponding cohort of healthy subjects to be used as controls (n=50); 3. Women with other non-oncological uterine conditions and oncological conditions affecting other organs (n=200); 4. An additional cohort will be recruited to validate the trained models (n=2800). This cohort will consist of postmenopausal women, aged between 50 and 80 years.
Key inclusion criteria (4 listed)
- Female sex
- Age between 50 and 80 years
- Willingness to participate in the study and signing of the informed consent
- Clinical condition of post-menopause
Key exclusion criteria (3 listed)
- Previous hysterectomy
- Hormone replacement therapy
- Immunosuppressive therapy
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 |
|---|---|---|
| Metabolomic profilingBlood samples will be collected from these subjects, and following metabolomic profiling, the data will provide the foundation for training machine learning models capable of recognizing the metabolomic profiles of subjects with endometrial carcinoma and differentiating them from subjects with other conditions. | Other | Additional cohort will be recruited to validate the trained models, Cohort of healthy subjects to be used as controls, Cohort of other non-oncological uterine conditions and oncological conditions affecting other organ, Cohort of women with endometrial carcinoma |
Primary outcome
Creation and Testing of a Metabolomic Signature for Endometrial Carcinoma Screening
Time frame: 24 months
Evaluation of the Ability of the Metabolomic Signature to Discriminate Between Neoplasms of Different Histological Origins
Time frame: 24 months
Validation of the Developed Model in a Real-World Clinical Setting
Time frame: 24 months
2 secondary outcomes
Creation of a Predictive Signature for Therapy Response in Endometrial Carcinoma
Time frame: 24 months
Creation and Testing of Metabolomic Signatures for Screening Other Neoplastic Conditions (Breast Cancer, Colorectal Cancer, etc.)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
Related trials for Endometrial Carcinoma (EC)
Active, not recruitingPhase 3
Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma
Endometrial Cancer
Recruiting
A Study of Short-course Hypofractionated Online-adaptive Radiotherapy for the Post-operative Treatment of Endometrial Cancer: Tolerability and Feasibility
Endometrial Carcinoma (EC)
Active, not recruitingPhase 1
First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors
Neoplasms
Active, not recruitingObservational study
Endometrial Cancer Vaginal Fluid Specimen Collection Study
Abnormal Uterine Bleeding (AUB), Endometrial Cancer
RecruitingObservational study
Prognosis and Therapeutic Implications in Molecular High-Risk Non-Myoinvasive Endometrial Cancer
Endometrial Cancer, Endometrial Carcinoma (EC)
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.
Antonella De Luca principal investigator
IRCCS I.N.T. "G. Pascale"
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 Carcinoma (EC), run by National Cancer Institute, Naples at 1 site in Italy.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 25 Mar 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonella De Luca (08117770603, a.deluca@istitutotumori.na.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation and Testing of a Metabolomic Signature for Endometrial Carcinoma Screening (time frame: 24 months). The study lists 3 primary outcomes in all. 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 25 Mar 2025.