Plasma ctDNA Detection in Diagnosis of Epithelial Ovarian Cancer.

NCT03155451 | Completed DMC

• 1 other identifier: [2017]012
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological diagnosis of ovarian lumps

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

  One week after surgery

Secondary Outcomes (2)

• sensitivity (true positive rate)

  2 year

• Specificity (true negative rate)

  2 year

Study Arms (1)

Epithelial ovarian cancer

patients receive the ctDNA methylation markers screening

Diagnostic Test: methylation markers screening

Interventions

methylation markers screening DIAGNOSTIC_TEST

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

Epithelial ovarian cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Adult women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200126, China

Location

Related Publications (2)

• 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.

  PMID: 26516143 BACKGROUND

• 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.

  PMID: 25707631 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

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

Study Officials

• Yu Wang, M.D.

  Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: May 13, 2017
• First Posted: May 16, 2017
• Study Start: August 14, 2017
• Primary Completion: October 18, 2017
• Study Completion: October 18, 2017
• Last Updated: October 19, 2017

Record last verified: 2017-10

Locations

CN (1)