NCT06893861

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

March 18, 2025

Last Update Submit

March 18, 2025

Conditions

Endometrial Carcinoma (EC)

Outcome Measures

Primary Outcomes (3)

  • Creation and Testing of a Metabolomic Signature for Endometrial Carcinoma Screening

    24 months

  • Evaluation of the Ability of the Metabolomic Signature to Discriminate Between Neoplasms of Different Histological Origins

    24 months

  • Validation of the Developed Model in a Real-World Clinical Setting

    24 months

Secondary Outcomes (2)

  • Creation of a Predictive Signature for Therapy Response in Endometrial Carcinoma

    24 months

  • Creation and Testing of Metabolomic Signatures for Screening Other Neoplastic Conditions (Breast Cancer, Colorectal Cancer, etc.)

    24 months

Study Arms (4)

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

This cohort will consist of postmenopausal women, aged between 50 and 80 years.

Other: Metabolomic profiling

Interventions

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.

Additional cohort will be recruited to validate the trained modelsCohort of healthy subjects to be used as controlsCohort of other non-oncological uterine conditions and oncological conditions affecting other organCohort of women with endometrial carcinoma

Eligibility Criteria

Age50 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Previous hysterectomy
  • Hormone replacement therapy
  • Immunosuppressive therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Nazionale Tumori | "Fondazione Pascale"

Napoli, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Antonella De Luca

    IRCCS I.N.T. "G. Pascale"

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonella De Luca

CONTACT

08117770603a.deluca@istitutotumori.na.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2025

First Posted

March 25, 2025

Study Start

July 6, 2023

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

March 25, 2025

Record last verified: 2025-03

Locations

IT(1)