Plasma ctDNA Detection in Diagnosis of Epithelial Ovarian Cancer.

Epithelial Ovarian Cancer Clinical Trial

— ctDNA_EOC  

Official title:

Plasma ctDNA Detection in Diagnosis of Epithelial Ovarian Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03155451
• Other study ID #: [2017]012
• Status: Completed
• Phase: N/A
• First received: May 13, 2017
• Last updated: October 18, 2017
• Start date: August 14, 2017
• Est. completion date: October 18, 2017

Study information

• Verified date: October 2017
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 18, 2017
• Est. primary completion date: October 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epithelial Ovarian Cancer
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms

Intervention

Diagnostic Test:
• methylation markers screening
ctDNA extraction from plasma samples;bisulfite-treated DNA;DNA methylation levels by deep sequencing-Sequencing; data analysis

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological diagnosis of ovarian lumps	Pathological diagnosis of ovarian lumps,including immunohistochemical information and HE staining information.	One week after surgery
Secondary	sensitivity (true positive rate)	The proportion of persons with disease who have a positive test (positive test results among persons with disease)	2 year
Secondary	Specificity (true negative rate)	The proportion of persons without disease who have a negative test (negative test results among persons without disease)	2 year