Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative

Training set

VERIFICATION SET

Roberto Angioli, MD

The purpose of this study was to obtain a predictive model to asses the Risk of Endometrial Malignancy (REM) in women with ultrasound endometrial abnormalities.

Objective: It is often difficult to distinguish a benign endometrial disease from a malignancy and tools to help physician are needed, in order to triage patients into high and low risk of endometrial cancer (EC). The purpose of this study was to obtain a predictive model to asses the Risk of Endometrial Malignancy (REM) in women with ultrasound endometrial abnormalities.Women, between 45 and 80 years, diagnosed with ultrasound endometrial abnormalities and scheduled to have surgery were enrolled on a prospective study at Department of Gynaecologic Oncology of Campus Bio-Medico of Rome. Preoperative clinical, ultrasound and laboratory features were taken into account. Logistic regression algorithm was utilized to categorize patients into low and high risk groups for EC.

REM (Risk Of Endometrial Malignancy)

REM (Risk Of Endometrial Malignancy): A Proposal for a New Scoring System to Evaluate Risk of Endometrial Malignancy

We consider training and verification set together to evaluate the overall sensitivity and specificity of predictive tool

We select patients affected by endometrial cancer and benign endometrial disease. Preoperative they underwent to pelvic ultrasound, CA125 and HE4 dosage and anamnesis. They will be considered as training group to obtaine the probability of endometrial malignancy based on HE4, ultrasound features and symptoms.

We select a verification set, composed by endometrial cancer disease and benign endometrial pathologies patients. In this set we apply the risk of endometrial cancer tool, obtained in the training set, in order to verify the sensitivity, specificity and reproducibility.

Campus Bio-Medico University

Professor

Neoplasms

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Methylation testing of host DNA, namely, OPCML, FODX3 and CDH13, in the peripheral serum

DNA methylation testing

Lei Li, M.D.

Ming Wu, M.D.

Lei Li, MD

Liquid biopsy is challenging for the diagnosis of epithelial ovarian cancer (EOC). In this study, we performed the methylation testing of host DNA, namely, OPCML, FODX3 and CDH13, in the peripheral serum to discover the diagnostic and supervision roles of DNA methylation in EOC patients. The study compromises two stages.

In the training set, DNA methylation testing is performed in the ovarian tissues from EOC and paired benign ovarian tumor patients. The cut-off values of methylation are produced in this stage. On the meantime, serum DNA methylation testing is also performed to reveal its accordance and accuracy compared with the results of ovarian tissues.

In the validation set, serum DNA methylation testing is performed in unselected ovarian tumor patients with definite cut-off values to validate its accuracy based on known histology of ovarian tumors.

In training and validation sets, serum DNA methylation is also performed after major surgeries for EOC as to illustrate the changes of methylation testing, therefore, reflection the supervision role of DNA methylation.

All eligible patients accept DNA methylation testing in serum and in ovarian tissues.

Cell-free DNA Methylation for Epithelial Ovarian Cancer

Cell-free DNA Methylation for the Diagnosis and Monitoring of Epithelial Ovarian Cancer: The Training and Validation Sets in China

The cut-off values are achieve by paired epithelial ovarian cancer and benign ovarian tumor patients.

The accuracy is supported by sensitivity, specificity, negative predictive value and positive predictive value.

Lei Li

Endometrial Neoplasms

Uterine Neoplasms

All eligible participants consenting to participate the study.

Methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177

Liquid biopsy is challenging for the diagnosis of endometrial cancer. In this study, investigators perform the methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177, in the peripheral serum to discover the diagnostic and supervision roles of DNA methylation in endometrial cancer. The study compromises two stages.

In the training set, DNA methylation testing is performed in the endometrial tissues from patients with endometrial cancer and paired benign uterine lesions. The cut-off values of methylation are produced in this stage. On the meantime, DNA methylation testing is also performed in serum and in cervical cytology to reveal its accordance and accuracy compared with the results of endometrial tissues.

In the validation set, serum DNA methylation testing is performed in unselected patients with definite endometrial histology to validate its accuracy.

In training and validation sets, serum DNA methylation is also performed after major surgeries for endometrial cancer as to illustrate the changes of methylation testing, therefore, reflection the supervision role of DNA methylation.

All eligible patients accept DNA methylation testing in serum, cervical cytology and endometrial tissues.

Cell-free DNA Methylation for Endometrial Cancer

Cell-free DNA Methylation for the Diagnosis and Monitoring of Endometrial Cancer: The Training and Validation Sets in China

The cut-off values are achieved by paired endometrial cancer and benign uterine tumor patients

The accuracy is supported by sensitivity, specificity, negative predictive value and positive predictive value

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
REM (Risk Of Endometrial Malignancy)	NCT01830192	Endometrial Dis...	Training set VERIFICATION SE...	45 Years - 80 Years	Campus Bio-Medico University
Cell-free DNA Methylation for Epithelial Ovarian Cancer	NCT04651946	Epithelial Ovar... DNA Methylation Benign Ovarian ... Training Set Validation Set Cell-free DNA Liquid Biopsy	DNA methylation...	18 Years -	Peking Union Medical College Hospital
Cell-free DNA Methylation for Epithelial Ovarian Cancer	NCT04651946	Epithelial Ovar... DNA Methylation Benign Ovarian ... Training Set Validation Set Cell-free DNA Liquid Biopsy	DNA methylation...	18 Years -	Peking Union Medical College Hospital
Cell-free DNA Methylation for Endometrial Cancer	NCT04651738	Endometrial Can... Liquid Biopsy DNA Methylation Cervical Cytolo... Diagnostic Accu... Training Set Validation Set	DNA methylation...	18 Years -	Peking Union Medical College Hospital
REM (Risk Of Endometrial Malignancy)	NCT01830192	Endometrial Dis...	Training set VERIFICATION SE...	45 Years - 80 Years	Campus Bio-Medico University
Cell-free DNA Methylation for Endometrial Cancer	NCT04651738	Endometrial Can... Liquid Biopsy DNA Methylation Cervical Cytolo... Diagnostic Accu... Training Set Validation Set	DNA methylation...	18 Years -	Peking Union Medical College Hospital

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