A Genomic Analysis of Evolution of Epithelia Ovarian Tumors

November 13, 2018 updated by: Lei Li

A Genomic Analysis on the Evolution of Epithelia Ovarian Tumors

Epithelial ovarian carcinomatous and borderline components sometimes appeared in one patient. This study aims to analyze the genomic patterns of the carcinomatous and borderline components in the ovarian epithelial tissues. These tissues will be collected from paraffin section by microdissection to distinguish normal, carcinomatous and borderline tissues.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Lei Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All patients with diagnosis of primary epithelial ovarian borderline tumor with cancer will be included.

Description

Inclusion Criteria:

  • Confirmed primary epithelial ovarian borderline tumor with cancer
  • Signed an approved informed consents
  • Feasible for sampling

Exclusion Criteria:

  • Not meeting all of the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequencies of somatic driving mutations
Time Frame: Two years
The differences of frequencies of somatic driving mutations will be compared between normal, carcinomatous and borderline tissues.
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: Five years
Progression-free survival between patients with differential expressed multi-omics will be compared.
Five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 10, 2018

Primary Completion (ANTICIPATED)

December 23, 2020

Study Completion (ANTICIPATED)

December 23, 2020

Study Registration Dates

First Submitted

November 9, 2018

First Submitted That Met QC Criteria

November 13, 2018

First Posted (ACTUAL)

November 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 15, 2018

Last Update Submitted That Met QC Criteria

November 13, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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