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A Multi-omics Study of Epithelial Ovarian Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03742856
Recruitment Status : 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

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.

Condition or disease Intervention/treatment
Epithelial Ovarian Cancer Tumor Invasiveness Whole Exome Sequencing Transcriptomics Metabolomics Tumorigenesis Combination Product: A multi-omics analysis

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Multi-omics Study on the Invasiveness of Epithelial Ovarian Cancer
Actual Study Start Date : November 10, 2018
Estimated Primary Completion Date : November 23, 2020
Estimated Study Completion Date : November 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer


Intervention Details:
  • Combination Product: A multi-omics analysis
    A multi-omics analysis including whole exome sequencing, transcriptomics and metabolomics.


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 patients of different FIGO stages and different pathological subtypes.


Secondary Outcome Measures :
  1. Frequencies of alteration of RNA expression [ Time Frame: Two years ]
    The alteration of RNA expression, including mRNA, miRNA, and lncRNA, will be compared between patients of different FIGO stages and different pathological subtypes.

  2. Frequencies of alteration of protein expression and signal pathway [ Time Frame: Two years ]
    The alteration of patterns of protein expression and signal pathway will be compared between patients of different FIGO stages and different pathological subtypes.

  3. 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
An 8 ml peripheral venous blood, and 50 μL cancer tissue and tissue adjacent to cancer will be collected from eligible patients.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

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

Exclusion Criteria:

  • Not meeting all of the inclusion criteria

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): NCT03742856


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
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Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03742856    
Other Study ID Numbers: EOC-OMICS
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
Carcinogenesis
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes