HPV Genotype Attribution and Disease Burden of Anal Cancer in China
Understanding the Human Papillomavirus Genotype Attribution and Disease Burden of Anal Cancer in China: A Multicenter Hospital-based Study
1 other identifier
observational
300
1 country
1
Brief Summary
To demonstrate HPV prevalence and its genotype distributions in anal cancer in China and to describe demographic and clinical features of HPV-related anal cancer in China; To describe the epidemiological characteristics ,trends and of disease burden of anal cancer in China
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2025
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
October 31, 2024
CompletedFirst Posted
Study publicly available on registry
November 1, 2024
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
February 12, 2026
August 1, 2025
2.6 years
October 31, 2024
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Prevalence and types of distribution of HPV
From enrollment to pre-treatment
Incidence of anal-cancers-associated complications
with or without HPV infection by subgroups of sex, age at diagnosis, sexual orientation, and stage at diagnosis (Stage I, II, III, IV, unknown)
From enrollment to pre-treatment
Routine laboratory testing results
From enrollment to pre-treatment
Secondary Outcomes (3)
Incidence rates of anal cancer in China
From enrollment to pre-treatment
Mortality rate of anal cancer in China
From enrollment to pre-treatment
Annual percentage changes (APCs) and average APCs (AAPCs)
From enrollment to pre-treatment
Eligibility Criteria
1. Patients with anal canal cancer: patients with anal canal cancer originating from the superior border of the functional anal canal (separated from the rectum) and defined as the palpable upper border of the anal sphincter and puborectalis muscles of the anorectal ring. It is approximately 3 to 5 cm in length, and its inferior border starts at the anal verge, the lowermost edge of the sphincter muscles, corresponding to the introitus of the anal orifice. 2. Patients with perianal cancer: The perianal region starts at the anal verge and includes the perianal skin over a 5-cm radius from the squamous mucocutaneous junction
You may qualify if:
- (1) Patients diagnosed with anal cancers, (2) Patients without radiation or chemotherapy prior to specimen collection;
You may not qualify if:
- (1) Patients with HIV infection, (2) Patients with immunosuppression after solid organ transplantation, (3) Those who do not agree to specimen collection and testing, (4) For retrospective study cases, those who without specimen.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Biospecimen
In this study, the qualified specimens will be obtained by biopsy, scraping, and swab for HPV DNA detection. Cancer tissue will be taken from patients with anal cancers. For surgical patients, cancer tissue can be obtained by biopsy or retrospective paraffin embedded tissue, for non-surgical patients, tissue can be obtained by biopsy. For tissue samples, cut about 5-25mg of the sample, put it into a 1.5ml centrifuge tube, add 180 Buffer AL and 20ul proteinase K solution, shake and mix well, centrifuge at low speed, and then store for testing. For retrospective paraffin embedded specimens, use a scalpel to remove excess paraffin and cut a 10um thick slice. If the surface of the specimen is exposed to air, discard the first 2-3 slices. Disassemble the microtome between blocks for decontamination.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Department
Study Record Dates
First Submitted
October 31, 2024
First Posted
November 1, 2024
Study Start
June 1, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
February 12, 2026
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share