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NCT Number: NCT06670495

HPV Genotype Attribution and Disease Burden of Anal Cancer in China

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

Recruiting

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Key information

Conditions

Anal Cancer Anus Diseases Anus Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location status: Recruiting

Location contact

Ying Zheng

CONTACT

[email protected]

8621-64175590

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • (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.

Treatment and study plan

Primary outcomes

  1. Prevalence and types of distribution of HPV

    Time frame: From enrollment to pre-treatment

  2. 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)

  3. Routine laboratory testing results

    Time frame: From enrollment to pre-treatment

Secondary outcomes

  1. Incidence rates of anal cancer in China

    Time frame: From enrollment to pre-treatment

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

  2. Mortality rate of anal cancer in China

    Time frame: From enrollment to pre-treatment

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

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

    Time frame: From enrollment to pre-treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Zheng

CONTACT

[email protected]

86-21-64175590

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Understanding the Human Papillomavirus Genotype Attribution and Disease Burden of Anal Cancer in China: A Multicenter Hospital-based Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 1, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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