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RecruitingNCT06670495Updated Feb 12, 2026

HPV Genotype Attribution and Disease Burden of Anal Cancer in China

An observational study in Anal Cancer, sponsored by Fudan University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-02-12.

Sponsored by Fudan University · Observational

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 5 months later.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
300
Sex
All
01

Study 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

02

Conditions studied

  • Anal Cancer

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Keywords

  • HPV prevalence
  • HPV genotype
  • Anal cancer
03

In context

Anus Neoplasms

297 studies on the registry are indexed under Anus Neoplasms; 74 are open to participants now.

This study's planned enrollment of 300 is above the median of 144 across 75 observational studies indexed under Anus Neoplasms.

Browse Anus Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,315 studies on the registry; 643 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

  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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (1) Patients diagnosed with anal cancers, (2) Patients without radiation or chemotherapy prior to specimen collection;

Exclusion criteria

Exclusion Criteria:

  • (1) Patients with infection, (2) Patients with after solid organ transplantation, (3) Those who do not agree to specimen collection and testing, (4) For retrospective study cases, those who without specimen.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
300 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Prevalence and types of distribution of HPV

    Time frame: From enrollment to pre-treatment

  2. 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)

    Time frame: From enrollment to pre-treatment

  3. Routine laboratory testing results

    Time frame: From enrollment to pre-treatment

Secondary outcomes

  1. Incidence rates of anal cancer in China

    overall and for 5-year calendar periods 2001-2005, 2006-2010, and 2011-2015

    Time frame: From enrollment to pre-treatment

  2. Mortality rate of anal cancer in China

    overall and for 5-year calendar periods 2001-2005, 2006-2010, and 2011-2015

    Time frame: From enrollment to pre-treatment

  3. Annual percentage changes (APCs) and average APCs (AAPCs)

    Time frame: From enrollment to pre-treatment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06670495
Lead sponsor
Fudan University
Responsible party
Ying Zheng (Chief of Department, Fudan University) — Principal investigator
First posted
Nov 1, 2024
Start date
Jun 1, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Feb 12, 2026

Study contacts

Ying Zheng
Contact
zhengying@fudan.edu.cn
86-21-64175590

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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