Plasma ctDNA Detection in Diagnosis of Epithelial Ovarian Cancer. (ctDNA_EOC)

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.

Study Overview

• Status: Completed
• Conditions: Epithelial Ovarian Cancer
• Intervention / Treatment: Diagnostic test: methylation markers screening

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 Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200126
      • Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

consecutive colletion of patinets with ovarian cancer treatment at our clinical centre

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Epithelial ovarian cancer; patients receive the ctDNA methylation markers screening	Diagnostic test: methylation markers screening; ctDNA extraction from plasma samples;bisulfite-treated DNA;DNA methylation levels by deep sequencing-Sequencing; data analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological diagnosis of ovarian lumps	Pathological diagnosis of ovarian lumps，including immunohistochemical information and HE staining information.	One week after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Principal Investigator: Yu Wang, M.D., Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Publications and helpful links

General Publications

• Wen L, Li J, Guo H, Liu X, Zheng S, Zhang D, Zhu W, Qu J, Guo L, Du D, Jin X, Zhang Y, Gao Y, Shen J, Ge H, Tang F, Huang Y, Peng J. Genome-scale detection of hypermethylated CpG islands in circulating cell-free DNA of hepatocellular carcinoma patients. Cell Res. 2015 Nov;25(11):1250-64. doi: 10.1038/cr.2015.126. Epub 2015 Oct 30. Erratum In: Cell Res. 2015 Dec;25(12):1376.
• Nick AM, Coleman RL, Ramirez PT, Sood AK. A framework for a personalized surgical approach to ovarian cancer. Nat Rev Clin Oncol. 2015 Apr;12(4):239-45. doi: 10.1038/nrclinonc.2015.26. Epub 2015 Feb 24.

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2017
• Primary Completion (Actual): October 18, 2017
• Study Completion (Actual): October 18, 2017

Study Registration Dates

• First Submitted: May 13, 2017
• First Submitted That Met QC Criteria: May 13, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): October 19, 2017
• Last Update Submitted That Met QC Criteria: October 18, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: [2017]012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No