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CompletedNCT03155451ctDNA_EOCUpdated Oct 19, 2017

Plasma ctDNA Detection in Diagnosis of Epithelial Ovarian Cancer.

An observational study in Epithelial Ovarian Cancer, sponsored by RenJi Hospital. Completed at 1 site in China. Open to female participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-19.

Sponsored by RenJi Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
43
Ages
18 Years to 80 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Epithelial Ovarian Cancer
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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 43 is below the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
43 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Epithelial ovarian cancer

    patients receive the ctDNA methylation markers screening

    Diagnostic Test: methylation markers screening

Interventions

  • Diagnostic testmethylation markers screening

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

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What researchers measure

Primary outcomes

  1. Pathological diagnosis of ovarian lumps

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

    Time frame: One week after surgery

Secondary outcomes

  1. sensitivity (true positive rate)

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

    Time frame: 2 year

  2. Specificity (true negative rate)

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

    Time frame: 2 year

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Study locations

1 site
  • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
    Shanghai, Shanghai 200126, China
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References and documents

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. doi: 10.1038/cr.2015.141. PubMed 26516143 ↗
  • 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. PubMed 25707631 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03155451
Lead sponsor
RenJi Hospital
Responsible party
Wang Yu (M.D., RenJi Hospital) — Principal investigator
First posted
May 16, 2017
Start date
Aug 14, 2017
Primary completion
Oct 18, 2017
Completion
Oct 18, 2017
Last update
Oct 19, 2017

Study contacts

Yu Wang, M.D.
principal investigator · Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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