NCT03742856

Brief Summary

This study aims to analyze the multi-omics results between epithelial ovarian cancer (EOC) patient with different FIGO stages and pathological subtypes. The multi-omics profiles include whole exome sequencing, analysis of transcriptomics and metabolomics. A comprehensive multi-omics will reveal the invasiveness and tumorigenesis of EOC.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

November 10, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2020

Completed
Last Updated

November 15, 2018

Status Verified

November 1, 2018

Enrollment Period

2 years

First QC Date

November 9, 2018

Last Update Submit

November 13, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Frequencies of somatic driving mutations

    The differences of frequencies of somatic driving mutations will be compared between patients of different FIGO stages and different pathological subtypes.

    Two years

Secondary Outcomes (3)

  • Frequencies of alteration of RNA expression

    Two years

  • Frequencies of alteration of protein expression and signal pathway

    Two years

  • Progression-free survival

    Five years

Interventions

A multi-omics analysisCOMBINATION_PRODUCT

A multi-omics analysis including whole exome sequencing, transcriptomics and metabolomics.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients confirmed primary epithelial ovarian cancer will be included for analysis.

You may qualify if:

  • Confirmed primary epithelial ovarian cancer
  • Signed an approved informed consents
  • Feasible for biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

An 8 ml peripheral venous blood, and 50 μL cancer tissue and tissue adjacent to cancer will be collected from eligible patients.

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialCarcinogenesis

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lei Li, M.D.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

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 9, 2018

First Posted

November 15, 2018

Study Start

November 10, 2018

Primary Completion

November 23, 2020

Study Completion

November 23, 2020

Last Updated

November 15, 2018

Record last verified: 2018-11

Locations