NCT03742388

Brief Summary

Epithelial ovarian carcinomatous and borderline components sometimes appeared in one patient. This study aims to analyze the genomic patterns of the carcinomatous and borderline components in the ovarian epithelial tissues. These tissues will be collected from paraffin section by microdissection to distinguish normal, carcinomatous and borderline tissues.

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
40

participants targeted

Target at P25-P50 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
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2020

Completed
Last Updated

November 15, 2018

Status Verified

November 1, 2018

Enrollment Period

2.1 years

First QC Date

November 9, 2018

Last Update Submit

November 13, 2018

Conditions

Epithelial Ovarian CancerEpithelial Ovarian Tumor of Borderline MalignancyDriving MutationsProgression-free Survival

Outcome Measures

Primary Outcomes (1)

  • Frequencies of somatic driving mutations

    The differences of frequencies of somatic driving mutations will be compared between normal, carcinomatous and borderline tissues.

    Two years

Secondary Outcomes (1)

  • Progression-free survival

    Five years

Eligibility Criteria

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

All patients with diagnosis of primary epithelial ovarian borderline tumor with cancer will be included.

You may qualify if:

  • Confirmed primary epithelial ovarian borderline tumor with cancer
  • Signed an approved informed consents
  • Feasible for sampling

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

Tissues for genomic analysis will be collected from paraffin section by microdissection.

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

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 Disorders

Study Officials

  • Lei Li, M.D.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

13911988831lileigh@163.com

Study Design

Study Type
observational
Observational Model
COHORT
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

December 23, 2020

Study Completion

December 23, 2020

Last Updated

November 15, 2018

Record last verified: 2018-11

Locations

CN(1)