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Plasma ctDNA Detection in Diagnosis of Epithelial Ovarian Cancer.

Plasma ctDNA Detection in Diagnosis of Epithelial Ovarian Cancer.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03155451
Acronym
ctDNA_EOC
Enrollment
43
Registered
2017-05-16
Start date
2017-08-14
Completion date
2017-10-18
Last updated
2017-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epithelial Ovarian Cancer

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.

Interventions

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

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pathological diagnosis of ovarian lumpsOne week after surgeryPathological diagnosis of ovarian lumps,including immunohistochemical information and HE staining information.

Secondary

MeasureTime frameDescription
sensitivity (true positive rate)2 yearThe proportion of persons with disease who have a positive test (positive test results among persons with disease)
Specificity (true negative rate)2 yearThe proportion of persons without disease who have a negative test (negative test results among persons without disease)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026