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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinogenesis
• Cervical Adenocarcinoma
• Genome-wide Association Study
• Human Papillomavirus
• Metabolome
• Prognosis
• Transcriptome
• Tumorigenesis
• Whole Exome Sequencing

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