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

• Conditions: Prognosis; High Grade Serous Carcinoma; Ovarian Cancer; Exosomes; Early Diagnosis
• Interventions: Genetic: Sequencing of miRNA/lncRNA

• Registration Number: NCT03738319
• Lead Sponsor: Lei Li

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-11-09
• Last Update Submitted: 2018-11-09
• Study Start: 2018-11-10
• Study First Posted: 2018-11-13
• Last Update Posted: 2018-11-14
• Primary Completion: 2019-11-23
• Study Completion: 2019-11-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HGSOC group	Sequencing of miRNA/lncRNA	This group includes patients of high grade serous ovarian cancer (HGSOC).
Control group	Sequencing of miRNA/lncRNA	This group includes patients of benign gynecologic diseases as control.

Primary Outcome Measures

Name	Time	Method
Differential expression of miRNA/lncRNA	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.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	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.

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China