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NCT03742869 Clinical Trial

HPV Integration and Tumorigenesis of Uterine Cervical Adenocarcinoma

Human Papillomavirus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03742869
Other study ID # HITA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 10, 2018
Est. completion date November 23, 2021

Study information
Verified date November 2018
Source Peking Union Medical College Hospital
Contact Lei Li, M.D.
Phone 13911988831
Email lileigh@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date November 23, 2021
Est. primary completion date November 23, 2021
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Combination Product:
• A multi-omics analysis
A multi-omics analysis including genome-wide association study, whole exome sequencing, transcriptomics and metabolomics.

Locations
Country Name City State
China Lei Li Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Frequencies of alteration of RNA expression The alteration of patterns of RNA expression, including mRNA, miRNA, and lncRNA, will be compared between patients with and without HPV integration. Two years
Secondary Frequencies of alteration of protein expression and signal pathway The alteration of patterns of protein expression and signal pathway will be compared between patients with and without HPV integration. Two years
Secondary Progression-free survival Progression-free survival between patients with differential expressed multi-omics will be compared. Five years
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