Anal CancerNCT06670495
HPV Genotype Attribution and Disease Burden of Anal Cancer in China
An observational study of Anal Cancer, run by Fudan University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anal Cancer
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 Dec 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- (1) Patients diagnosed with anal cancers, (2) Patients without radiation or chemotherapy prior to specimen collection;
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Ying Zheng, 8621-64175590, zhengying@fudan.edu.cn
About this study
Official title: Understanding the Human Papillomavirus Genotype Attribution and Disease Burden of Anal Cancer in China: A Multicenter Hospital-based Study
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
- Conditions
- Anal Cancer
- Keywords
- HPV prevalence, HPV genotype, Anal cancer
- Medical subject headings
- Anus Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and types of distribution of HPV
Measured: 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)
Measured: From enrollment to pre-treatment
Routine laboratory testing results
Measured: From enrollment to pre-treatment
Secondary outcomes (3)
Incidence rates of anal cancer in China
overall and for 5-year calendar periods 2001-2005, 2006-2010, and 2011-2015
Measured: From enrollment to pre-treatment
Mortality rate of anal cancer in China
overall and for 5-year calendar periods 2001-2005, 2006-2010, and 2011-2015
Measured: From enrollment to pre-treatment
Annual percentage changes (APCs) and average APCs (AAPCs)
Measured: From enrollment to pre-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Zheng, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670495
- Sponsor's protocol ID
- 2024-225-3778
- Status last verified
- Aug 2025
- First submitted
- 31 Oct 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Human Papillomavirus Genotype Attribution and Disease Burden of Anal Cancer in China: A Multicenter Hospital-based Study
- ClinicalTrials.gov ID
- NCT06670495
- Acronym / sponsor ID
- 2024-225-3778
- Conditions
- Anal Cancer
- Keywords
- HPV prevalence, HPV genotype, Anal cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- (1) Patients diagnosed with anal cancers, (2) Patients without radiation or chemotherapy prior to specimen collection;
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence and types of distribution of HPV
Time frame: From enrollment to pre-treatment
Incidence of anal-cancers-associated complications
Time frame: From enrollment to pre-treatment
with or without HPV infection by subgroups of sex, age at diagnosis, sexual orientation, and stage at diagnosis (Stage I, II, III, IV, unknown)
Routine laboratory testing results
Time frame: From enrollment to pre-treatment
3 secondary outcomes
Incidence rates of anal cancer in China
Time frame: From enrollment to pre-treatment
Mortality rate of anal cancer in China
Time frame: From enrollment to pre-treatment
Annual percentage changes (APCs) and average APCs (AAPCs)
Time frame: From enrollment to pre-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Zheng (86-21-64175590, zhengying@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and types of distribution of HPV (time frame: From enrollment to pre-treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.