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NCT03738319 Clinical Trial

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

Ovarian Cancer Clinical Trial

Official title:
Non-coding RNA in the Exosome of the Epithelia Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03738319
Other study ID # EOC-EXOSOME
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 10, 2018
Est. completion date November 23, 2019

Study information
Verified date November 2018
Source Peking Union Medical College Hospital
Contact Lei Li, M.D.
Phone 13911988831
Email lileigh@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 160
Est. completion date November 23, 2019
Est. primary completion date November 23, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Genetic:
• Sequencing of miRNA/lncRNA
Next generation sequencing of micro-RNA (miRNA) and long non-coding RNA (lncRNA)

Locations
Country Name City State
China Lei Li Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Differential expression of miRNA/lncRNA 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 Progression-free survival 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
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