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A Genomic Analysis of Evolution of Epithelia Ovarian Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03742388
Recruitment Status : Unknown
Verified November 2018 by Lei Li, Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Lei Li, Peking Union Medical College Hospital

Study Description
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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.

Condition or disease
Epithelial Ovarian Cancer Epithelial Ovarian Tumor of Borderline Malignancy Driving Mutations Progression-free Survival

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Genomic Analysis on the Evolution of Epithelia Ovarian Tumors
Actual Study Start Date : November 10, 2018
Estimated Primary Completion Date : December 23, 2020
Estimated Study Completion Date : December 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Five years ]
    Progression-free survival between patients with differential expressed multi-omics will be compared.


Biospecimen Retention:   Samples With DNA
Tissues for genomic analysis will be collected from paraffin section by microdissection.

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with diagnosis of primary epithelial ovarian borderline tumor with cancer will be included.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742388


Contacts
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Contact: Lei Li, M.D. 13911988831 ext 86 lileigh@163.com

Locations
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China, Beijing
Lei Li Recruiting
Beijing, Beijing, China, 100730
Contact: Lei Li, MD    13911988831 ext 86    lileigh@163.com   
Sponsors and Collaborators
Lei Li
Investigators
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Principal Investigator: Lei Li, M.D. Peking Union Medical College Hospital
More Information
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Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03742388    
Other Study ID Numbers: EOC-BORDERLINE
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
 Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type