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.
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
Previous hysterectomy
Hormone replacement therapy
Immunosuppressive therapy
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.
Cohort
Prospective
Metabolomic profiling
Other interventionBlood 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.
Creation and Testing of a Metabolomic Signature for Endometrial Carcinoma Screening
Evaluation of the Ability of the Metabolomic Signature to Discriminate Between Neoplasms of Different Histological Origins
Validation of the Developed Model in a Real-World Clinical Setting
Creation of a Predictive Signature for Therapy Response in Endometrial Carcinoma
Creation and Testing of Metabolomic Signatures for Screening Other Neoplastic Conditions (Breast Cancer, Colorectal Cancer, etc.)
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