HPV Integration and Tumorigenesis of Uterine Cervical Adenocarcinoma
A Multi-omics Study on the Human Papillomavirus Integration and Tumorigenesis of Uterine Cervical Adenocarcinoma
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2018
CompletedStudy Start
First participant enrolled
November 10, 2018
CompletedFirst Posted
Study publicly available on registry
November 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2021
CompletedNovember 15, 2018
November 1, 2018
3 years
November 9, 2018
November 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Frequencies of somatic driving mutations
The differences of frequencies of somatic driving mutations will be compared between patients with and without HPV integration.
Two years
Secondary Outcomes (3)
Frequencies of alteration of RNA expression
Two years
Frequencies of alteration of protein expression and signal pathway
Two years
Progression-free survival
Five years
Study Arms (2)
Patients with HPV integration
The HPV integration status will be checked by GWAS.
Patients without HPV integration
The HPV integration status will be checked by GWAS.
Interventions
A multi-omics analysis including genome-wide association study, whole exome sequencing, transcriptomics and metabolomics.
Eligibility Criteria
All patients confirmed primary adenocarcinoma of the uterine cervix
You may qualify if:
- Confirmed primary adenocarcinoma of the uterine cervix
- Signed an approved informed consents
- Feasible for biopsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lei Lilead
Study Sites (1)
Lei Li
Beijing, Beijing Municipality, 100730, China
Biospecimen
An 8 ml peripheral venous blood, and 50 μL cancer tissue and tissue adjacent to cancer will be collected from eligible patients.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lei Li, M.D.
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 9, 2018
First Posted
November 15, 2018
Study Start
November 10, 2018
Primary Completion
November 23, 2021
Study Completion
November 23, 2021
Last Updated
November 15, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- All data will be available to all researchers once related papers have been accepted publicly, and will be available for ever.
All data will be available to all researchers.