HPV Integration and Tumorigenesis of Uterine Cervical Adenocarcinoma

November 13, 2018 updated by: Lei Li

A Multi-omics Study on the Human Papillomavirus Integration and Tumorigenesis of Uterine Cervical Adenocarcinoma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

  • China
    • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All patients confirmed primary adenocarcinoma of the uterine cervix

Description

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

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

Cohorts and Interventions

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.

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 patients with and without HPV integration.
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
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.
Two years
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.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lei Li

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)

November 23, 2021

Study Completion (Anticipated)

November 23, 2021

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

Other Study ID Numbers

  • HITA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data will be available to all researchers.

IPD Sharing Time Frame

All data will be available to all researchers once related papers have been accepted publicly, and will be available for ever.

IPD Sharing Supporting Information Type

  • CSR

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.

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