- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03742388
A Genomic Analysis of Evolution of Epithelia Ovarian Tumors
November 13, 2018 updated by: Lei Li
A Genomic Analysis on the Evolution of Epithelia Ovarian Tumors
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.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Recruiting
- Lei Li
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
All patients with diagnosis of primary epithelial ovarian borderline tumor with cancer will be included.
Description
Inclusion Criteria:
- Confirmed primary epithelial ovarian borderline tumor with cancer
- Signed an approved informed consents
- Feasible for sampling
Exclusion Criteria:
- Not meeting all of the inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequencies of somatic driving mutations
Time Frame: Two years
|
The differences of frequencies of somatic driving mutations will be compared between normal, carcinomatous and borderline tissues.
|
Two years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-free survival
Time Frame: Five years
|
Progression-free survival between patients with differential expressed multi-omics will be compared.
|
Five years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 10, 2018
Primary Completion (ANTICIPATED)
December 23, 2020
Study Completion (ANTICIPATED)
December 23, 2020
Study Registration Dates
First Submitted
November 9, 2018
First Submitted That Met QC Criteria
November 13, 2018
First Posted (ACTUAL)
November 15, 2018
Study Record Updates
Last Update Posted (ACTUAL)
November 15, 2018
Last Update Submitted That Met QC Criteria
November 13, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- EOC-BORDERLINE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.