HPV Genotype Attribution and Disease Burden of Anal Cancer in China
ConditionAnal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFudan University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(1) Patients diagnosed with anal cancers, (2) Patients without radiation or chemotherapy prior to specimen collection;
Disqualifiers
(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 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
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Prevalence and types of distribution of HPV
Time frame
From enrollment to pre-treatment2
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-treatment3
Routine laboratory testing results
Time frame
From enrollment to pre-treatmentSecondary 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-treatment2
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-treatment3
Annual percentage changes (APCs) and average APCs (AAPCs)
Time frame
From enrollment to pre-treatmentSponsors and contacts
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Source ClinicalTrials.gov