Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

HPV Integration and Tumorigenesis of Uterine Cervical Adenocarcinoma

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: NCT03742869
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 uterine cervical adenocarcinoma patients with and without human papillomavirus (HPV) infections. The multi-omics profiles include genome wide association study (GWAS), whole exome sequencing, analysis of transcriptomics and metabolomics. The HPV integration status is interpreted by GWAS. A comprehensive multi-omics will reveal the role of HPV integration in the molecular mechanism of tumorigenesis and prognosis of uterine cervical adenocarcinoma.

Condition or disease Intervention/treatment
Cervical Adenocarcinoma Human Papillomavirus Genome-wide Association Study Whole Exome Sequencing Transcriptome Metabolome Tumorigenesis Prognosis Combination Product: A multi-omics analysis

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Multi-omics Study on the Human Papillomavirus Integration and Tumorigenesis of Uterine Cervical Adenocarcinoma
Actual Study Start Date : November 10, 2018
Estimated Primary Completion Date : November 23, 2021
Estimated Study Completion Date : November 23, 2021

Group/Cohort Intervention/treatment
Patients with HPV integration
The HPV integration status will be checked by GWAS.
Combination Product: A multi-omics analysis
A multi-omics analysis including genome-wide association study, whole exome sequencing, transcriptomics and metabolomics.

Patients without HPV integration
The HPV integration status will be checked by GWAS.
Combination Product: A multi-omics analysis
A multi-omics analysis including genome-wide association study, 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 with and without HPV integration.


Secondary Outcome Measures :
  1. Frequencies of alteration of RNA expression [ Time Frame: Two years ]
    The alteration of patterns of RNA expression, including mRNA, miRNA, and lncRNA, will be compared between patients with and without HPV integration.

  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 with and without HPV integration.

  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.


Layout table for eligibility information
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 confirmed primary adenocarcinoma of the uterine cervix
Criteria

Inclusion Criteria:

  • Confirmed primary adenocarcinoma of the uterine cervix
  • 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): NCT03742869


Contacts
Layout table for location contacts
Contact: Lei Li, M.D. 13911988831 ext 86 lileigh@163.com

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Lei Li, M.D. Peking Union Medical College Hospital
Layout table for additonal information
Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03742869    
Other Study ID Numbers: HITA
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data will be available to all researchers.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: All data will be available to all researchers once related papers have been accepted publicly, and will be available for ever.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Carcinogenesis
Cell Transformation, Neoplastic
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes