Cell-free DNA Methylation for Epithelial Ovarian Cancer

NCT04651946 | Unknown Phase 2

• 1 other identifier: EOC-METHY
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epithelial Ovarian Cancer; DNA Methylation; Benign Ovarian Tumor; Training Set; Validation Set; Cell-free DNA; Liquid Biopsy

Outcome Measures

Primary Outcomes (1)

• Cut-off values of targeted DNA methylation in epithelial ovarian cancer

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

  Two years

Secondary Outcomes (1)

• Accuracy of serum DNA methylation in epithelial ovarian cancer

  Two years

Interventions

DNA methylation testing DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• With definite histological diagnosis of epithelial ovarian cancer and paired benign ovarian tumor in training set, and with definite histological diagnosis of ovarian tumor in validation set.
• With sufficient fresh peripheral serum and ovarian samples for DNA methylation testing before with or without after major surgeries.
• Aged 18 years or older.
• Signed an approved informed consents

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Lei Li, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

+8613911988831; lileigh@163.com

Ming Wu, M.D.

CONTACT

+8613801224549; wuming@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 3, 2020
• Study Start: November 26, 2020
• Primary Completion: November 26, 2022
• Study Completion: November 26, 2022
• Last Updated: December 3, 2020

Record last verified: 2020-11

Locations

CN (1)