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Trial Title:
Determining the Frequency of Occurrence and Defining the Most Appropriate Screening Test for Anal Intraepithelial Neoplasia (AIN) in Patients With Human Papillomavirus (HPV) Related Gynecological Diseases.
NCT ID:
NCT06574087
Condition:
HPV-Related Carcinoma
HPV Infection
Conditions: Official terms:
Papillomavirus Infections
Neoplasms
Genital Diseases, Female
Conditions: Keywords:
anal cancer
HPV
anal intraepithelial neoplasia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
hrHPV test and cytology
Description:
Perfomance of hrHPV test and cytology
Arm group label:
HPV- related gynecological disease arm
Arm group label:
Placebo arm
Summary:
The primary aim of the study is to determine the total risk of AIN in group of HPV-RGD
survivors and additionally to establish an exact risk for each of HPV-related
gynecological precancers/cancers. Moreover, the most appropriate screening test for
HSIL(AIN) in this group of patients will be determined. It will be effectuated by
performing two kinds of tests: hrHPV test for the 14 most common oncogenic HPV types and
the liquid cytology from both the lower genital tract and anal canal with subsequent high
resolution anoscopy (HRA) with potential biopsy/excision of suspected lesions and
histopathological examination.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- HPV related gynecological disease confirmed in histo-pathological examination
- the posibility to obtain material from gynecological organ and from anal canal
Gender:
Female
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
PCK Marine Hospital in Gdynia
Address:
City:
Gdynia
Zip:
81-519
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Michał Brzeziński
Phone:
505174271
Email:
m.brzezinski@gumed.edu.pl
Investigator:
Last name:
Michał Brzeziński
Email:
Principal Investigator
Investigator:
Last name:
Maciej Stukan
Email:
Sub-Investigator
Start date:
January 13, 2023
Completion date:
January 2027
Lead sponsor:
Agency:
PCK Marine Hospital in Gdynia
Agency class:
Other
Collaborator:
Agency:
Medical University of Gdansk
Agency class:
Other
Source:
PCK Marine Hospital in Gdynia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06574087
