Skip to main content
OpenTrials
Completed

NCT Number: NCT03155451

Plasma ctDNA Detection in Diagnosis of Epithelial Ovarian Cancer.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200126, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

methylation markers screening

Diagnostic Test

ctDNA extraction from plasma samples;bisulfite-treated DNA;DNA methylation levels by deep sequencing-Sequencing; data analysis

Primary outcomes

  1. Pathological diagnosis of ovarian lumps

    Time frame: One week after surgery

    Pathological diagnosis of ovarian lumps，including immunohistochemical information and HE staining information.

Secondary outcomes

  1. sensitivity (true positive rate)

    Time frame: 2 year

    The proportion of persons with disease who have a positive test (positive test results among persons with disease)

  2. Specificity (true negative rate)

    Time frame: 2 year

    The proportion of persons without disease who have a negative test (negative test results among persons without disease)

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Acronym: ctDNA_EOC

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 16, 2017
Registry last updated
Oct 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.