Non-coding RNA in the Exosome of the Epithelia Ovarian Cancer

November 9, 2018 updated by: Lei Li
This study aims to analyze the expression of micro-RNA (miRNA) and long non-coding RNA (lncRNA) by next-generation sequencing in patients with high grade serous ovarian cancer (HGSOC) and benign gynecologic diseases. The candidate miRNA/lncRNA will be validated as biomarker for the detection and prognosis of HGSOC.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

160

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

  • China
    • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

There will be 20 patients of high grade serous ovarian cancer (HGSOC) and 20 patients with benign gynecologic diseases, whose data will be applied for construction of diagnostic model of miRNA/lncRNA from exosome. There will be 120 patients suspected of HGSOC, whose data will be applied for validation of such diagnosis model.

Description

Inclusion Criteria:

  • Confirmed primary high grade serous ovarian cancer
  • Willing to accepted debulking surgeries and adjuvant chemotherapy
  • Good performance status
  • Aged 18 years or older
  • Signed an approved informed consents

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HGSOC group
This group includes patients of high grade serous ovarian cancer (HGSOC).
Genetic: Sequencing of miRNA/lncRNA
Next generation sequencing of micro-RNA (miRNA) and long non-coding RNA (lncRNA)
Control group
This group includes patients of benign gynecologic diseases as control.
Genetic: Sequencing of miRNA/lncRNA
Next generation sequencing of micro-RNA (miRNA) and long non-coding RNA (lncRNA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differential expression of miRNA/lncRNA
Time Frame: One year
Differential expression of micro-RNA (miRNA) and long non-coding RNA (lncRNA) will be compared between HGSOC group and control group, hence candidate miRNA/lncRNA will be validated as biomarker for the detection and prognosis of HGSOC.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: Five years
The progression-free survival of HGSOC patients will be compared between differential expressed candidate miRNA/lncRNA after they have completed debulking surgeries and adjuvant chemotherapy.
Five years

Collaborators and Investigators

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

Sponsor

Lei Li

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)

November 23, 2019

Study Completion (Anticipated)

November 23, 2019

Study Registration Dates

First Submitted

November 8, 2018

First Submitted That Met QC Criteria

November 9, 2018

First Posted (Actual)

November 13, 2018

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 9, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EOC-EXOSOME

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data will be available to all researchers.

IPD Sharing Time Frame

All data will be available to all researchers once related papers have been accepted publicly, and will be available for ever.

IPD Sharing Supporting Information Type

  • CSR

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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