HPV Integration and Tumorigenesis of Uterine Cervical Adenocarcinoma

• Conditions: Metabolome; Human Papillomavirus; Genome-wide Association Study; Whole Exome Sequencing; Tumorigenesis; Cervical Adenocarcinoma; Transcriptome; Prognosis
• Interventions: Combination Product: A multi-omics analysis

• Registration Number: NCT03742869
• Lead Sponsor: Lei Li

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-09
• Study Start: 2018-11-10
• Study First Submitted QC: 2018-11-13
• Last Update Submitted: 2018-11-13
• Study First Posted: 2018-11-15
• Last Update Posted: 2018-11-15
• Primary Completion: 2021-11-23
• Study Completion: 2021-11-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients without HPV integration	A multi-omics analysis	The HPV integration status will be checked by GWAS.
Patients with HPV integration	A multi-omics analysis	The HPV integration status will be checked by GWAS.

Primary Outcome Measures

Name	Time	Method
Frequencies of somatic driving mutations	Two years	The differences of frequencies of somatic driving mutations will be compared between patients with and without HPV integration.

Secondary Outcome Measures

Name	Time	Method
Frequencies of alteration of RNA expression	Two years	The alteration of patterns of RNA expression, including mRNA, miRNA, and lncRNA, will be compared between patients with and without HPV integration.
Progression-free survival	Five years	Progression-free survival between patients with differential expressed multi-omics will be compared.
Frequencies of alteration of protein expression and signal pathway	Two years	The alteration of patterns of protein expression and signal pathway will be compared between patients with and without HPV integration.

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China