ctDNA Methylation for Epithelial Ovarian Cancer

NCT05801263 | Recruiting

• 1 other identifier: OVAMethy
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

Ovarian cancer is one of the most dangerous and predominant gynecological cancers, with a high cancer-related mortality rate in women. However, current testing methods are still limited, and if detected early, patients have a five-year survival rate of 92%. Therefore, early diagnosis and detection are crucial for diagnosing and treating ovarian cancer. According to the results of the researchers' previous research, it has been found that CDO1 and HOXA9 genes are hypermethylated in ovarian cancer, and the expression of free DNA methylation in plasma can be used as one of the biomarkers for detection. In a single-center retrospective/prospective study, it has been demonstrated that the detection of CDO1 and HOXA9 methylation levels based on cell-free DNA in blood and comparison with ovarian pathology results can achieve \>80% sensitivity and specificity. To further explore the application of methylation detection technology in ovarian cancer, the application value of non-invasive diagnosis and prognosis follow-up will be explored to clarify the clinical application value of DNA methylation for early detection of ovarian cancer in the real world. The investigators will conduct a prospective multi-center cohort study, referred to as the OVAMethy study, which will involve more than ten research centers and is expected to recruit more than 5,000 clinical subjects to test the methylation detection kit and histopathology further, ROMA index and imaging results, and sensitivity and specificity technical performance parameters.

Conditions

Epithelial Ovarian Cancer; Circulating Tumor DNA; DNA Methylation; Non-invasive Diagnosis; CA125; Human Epididymis Protein 4; 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

CDO1 and HOXA9 methylation assay DIAGNOSTIC_TEST

CDO1 and HOXA9 methylation assay in plasma circulating tumor cells

Eligibility Criteria

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

Study Population

Patient with pelvic mass or adnexal mass ready for surgical exploration

You may qualify if:

• Outpatient routine follow-up population
• Age is greater than or equal to 18 years
• Not receiving any chemotherapy, physical therapy, or surgical treatment for ovarian lesions
• Wtih pathological ovarian results
• Willing to be tested and signed an informed consent form
• With available data of plasma CA125, Human epididymis protein 4 and effective imaging results

You may not qualify if:

• Not meeting all the including criteria
• WithoutoOvarian pathology or surgical pathology information could not be obtained
• 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)