Plasma ctDNA Detection in Diagnosis of Epithelial Ovarian Cancer.

Completed

• Conditions: Epithelial Ovarian Cancer
• Interventions: Diagnostic Test: methylation markers screening

• Registration Number: NCT03155451
• Lead Sponsor: RenJi Hospital

Brief Summary

Epithelial ovarian cancer constitutes one of the most common gynecological malignancies.Because the ovaries lie in the deep pelvic cavity,most ovarian cancer patients are asymptomatic, rendering the majority often diagnosed at an advanced stage.ctDNA in cancer patients often bears similar genetic and epigenetic features to the related tumor DNA.This study aims to detect plasma ctDNA in Diagnosis of Epithelial Ovarian Cancer.

Detailed Description

Epithelial ovarian cancer constitutes one of the most common gynecological malignancies, with an incidence rate of 3-12/100 000 woman per year. Because the ovaries lie in the deep pelvic cavity,most ovarian cancer patients are asymptomatic, rendering the majority often diagnosed at an advanced stage. Liquid biopsy, which is meant to detect cancers by sequencing the DNA in a few drops of a person's blood. It may detect cancers early, even before symptoms arise, when there is just a few cells in the blood circulation.

ctDNA in cancer patients often bears similar genetic and epigenetic features to the related tumor DNA. There is evidence that some of the ctDNA originates from tumor tissue. This, and the fact that ctDNA can easily be isolated from the circulation and other body fluids of patients, makes it a promising candidate as a non-invasive biomarker of cancer.

This study aims to detect plasma ctDNA in Diagnosis of Epithelial Ovarian Cancer.

Study Timeline

• Study First Submitted: 2017-05-13
• Study First Submitted QC: 2017-05-13
• Study First Posted: 2017-05-16
• Study Start: 2017-08-14
• Status Verified: 2017-10
• Primary Completion: 2017-10-18
• Study Completion: 2017-10-18
• Last Update Submitted: 2017-10-18
• Last Update Posted: 2017-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

Inclusion Criteria

• people aged 18years to 80years;
• Diagnosis of ovarian cancer is confirmed by two Pathologists independently;
• Pregnancy tests are negative.

Exclusion Criteria

• With other type of malignancies;
• someone who refuse to participate the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Epithelial ovarian cancer	methylation markers screening	patients receive the ctDNA methylation markers screening

Primary Outcome Measures

Name	Time	Method
Pathological diagnosis of ovarian lumps	One week after surgery	Pathological diagnosis of ovarian lumps，including immunohistochemical information and HE staining information.

Secondary Outcome Measures

Name	Time	Method
sensitivity (true positive rate)	2 year	The proportion of persons with disease who have a positive test (positive test results among persons with disease)
Specificity (true negative rate)	2 year	The proportion of persons without disease who have a negative test (negative test results among persons without disease)

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China