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

NCT03738319 | Unknown DMC

• 1 other identifier: EOC-EXOSOME
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

High Grade Serous Carcinoma; Ovarian Cancer; Exosomes; Prognosis; Early Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Progression-free survival

  Five years

Study Arms (2)

HGSOC group

This group includes patients of high grade serous ovarian cancer (HGSOC).

Genetic: Sequencing of miRNA/lncRNA

Control group

This group includes patients of benign gynecologic diseases as control.

Genetic: Sequencing of miRNA/lncRNA

Interventions

Sequencing of miRNA/lncRNA GENETIC

Next generation sequencing of micro-RNA (miRNA) and long non-coding RNA (lncRNA)

Control group; HGSOC group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

An 8 ml peripheral venous blood will be collected from the participants before and after interventions (i.e. surgery and/or chemotherapy)

MeSH Terms

Conditions

Ovarian Neoplasms; Disease

Interventions

RNA, Long Noncoding

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; 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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RNA, Untranslated; RNA; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Lei Li, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

13911988831; lileigh@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 13, 2018
• Study Start: November 10, 2018
• Primary Completion: November 23, 2019
• Study Completion: November 23, 2019
• Last Updated: November 14, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: All data will be available to all researchers once related papers have been accepted publicly, and will be available for ever.

Locations

CN (1)