ctDNA Methylation for Detecting Ovarian Cancer

NCT05801276 | Recruiting

• 1 other identifier: EOC-METHY2
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief Summary

Ovarian cancer is one of the most dangerous and leading gynecological cancer, with significant cancer-related mortality among women. However, current detection methods are still limited, with approximately 70% of patients with high-grade serous ovarian cancer often being advanced at the initial diagnosis and more than 80% with intraperitoneal spread. The five-year survival rate for late detection is only 29%; on the contrary, if detected early, the five-year survival rate can reach 92%. Therefore, early diagnosis and detection are essential in diagnosing and treating ovarian cancer. Liquid biopsy has attracted widespread attention because of its non-invasive, real-time, and dynamic characteristics. Cell-free DNA in plasma can identify a small tumor burden well and reflect the clinical cancer information of cells.The role of hypermethylation in developing malignant tumors has received increasing attention. Methylation is one of epigenetics and plays a vital role in the occurrence and development of tumors. According to previous research basis of the researchers, it has been found that CDO1 and HOXA9 genes show hypermethylation in ovarian cancer, and they are considered one of the biomarkers for detection. Therefore, this study will further explore the detection of CDO1 and HOXA9 methylation levels based on cell-free DNA in blood and compared with ovarian pathology results; the application of methylation detection technology in ovarian cancer/precancerous lesions will further explore the application value of non-invasive diagnosis and prognostic follow-up.This study will involve three centers and is expected to enroll more than 1,400 clinical subjects, further examine the consistency of methylation detection kits with the histopathological examination, ROMA index, and Sanger sequencing results, and obtain sensitivity and specificity technical performance parameters.

Conditions

Epithelial Ovarian Cancer; Circulating Tumor DNA; DNA Methylation; Non-invasive Diagnosis; CA125; Human Epididymis Protein 4; ROMA Index; Imaging Evaluation; Survival Prognosis

Outcome Measures

Primary Outcomes (2)

• Diagnostic sensitivity

  Diagnostic sensitivity of methylation assay for detecting epithelial ovarian cancer

  One month

• Diagnostic specificity

  Diagnostic specificity of methylation assay for detecting epithelial ovarian cancer

  One month

Secondary Outcomes (1)

• Progression-free survival

  Two years

Interventions

Methylation assay DIAGNOSTIC_TEST

Methylation assay of CDO1 and HOXA9 genes in plasma circulating tumor DNA

Eligibility Criteria

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

Study Population

Patients ready for surgical treatment for pelvic mass or adnexal mass. The study will also enroll several patients with primary breast cancer, lung cancer, colon cancer, uterine cervical cancer and uterine carcinomas.

You may qualify if:

• Patients ready for surgical treatment for pelvic mass or adnexal mass
• Age is greater than or equal to 18 years
• Not receiving any chemotherapy, physical therapy, or surgical treatment for ovarian lesions
• With ovarian pathology
• Willing to be tested and signed an informed consent form
• With available data of plasma CA125, Human epididymis protein 4 and effective imaging results
• The study will also enroll several patients with primary breast cancer, lung cancer, colon cancer, uterine cervical cancer and uterine carcinomas

You may not qualify if:

• Not meeting all the including criteria
• A sample of patients withdrawing from the trial
• Samples that the investigator believes should be excluded from this trial

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma circulating tumor DNA

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 6, 2023
• Study Start: March 24, 2023
• Primary Completion: March 24, 2024
• Study Completion: March 24, 2026
• Last Updated: April 6, 2023

Record last verified: 2023-03

Locations

CN (1)