Quantitative HPV Genotyping in Screening of Anal Intraepi... | NCT03742375

Studies
Quantitative HPV Genotyping in Screening of Anal Intraepithelial Neoplasia in HIV-positive Patients

NCT03742375

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Terminated

Last Update Posted

Nov 4, 2020Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Human Immunodeficiency Virus

Interventions

HPV genotyping

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID-19 pandemic

Expanded Access Info

Start Date

Aug 1, 2018Actual

Primary Completion Date

Nov 1, 2020Actual

Completion Date

Nov 1, 2020Actual

First Submitted Date

Oct 10, 2018

First Submission Date that Met QC Criteria

Nov 14, 2018

First Posted Date

Nov 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2020

Last Update Posted Date

Nov 4, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

prof. dr. Philip Roelandt, Assistant head of clinic Gastroenterology, Universitaire Ziekenhuizen KU LeuvenPrincipal Investigator

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Collaborators

Name	Class
Sciensano	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The pathophysiology from anal HPV infection to Anal Intraepithelial Neoplasia is less well understood than cervical HPV infection. In cervical screening programs it is well accepted that the sole presence of a high-risk HPV strain (irrespective of number of viral particles) is sufficient to justify further investigation and treatment. The investigators hypothesize that in anal HPV infection not only the presence but the extent of HPV infection (single genotype viral load) or combination of different HPV genotypes (cumulative viral load) is of importance in determining the risk of anal dysplasia.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HPV genotyping	Experimental		Diagnostic Test: HPV genotyping

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HPV genotyping	Diagnostic Test	Quantitative HPV genotyping on anal swab	HPV genotyping

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of HPV subtypes in HIV-positive patients	Retrieval of 1 anal swab before performing HRA to determine the HPV subtypes at that particular moment	1 minute

Secondary Outcomes

Measure	Description	Time Frame
Correlation between high-resolution anoscopy findings and quantitative HPV genotyping	Performing HRA (30 minutes) with or without biopsies, results biopsies up to 10 days	30 minutes up to 10 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

Stable HIV disease (i.e. receiving ART for at least 1 year, no adverse drug reactions requiring regular monitoring, no current illnesses or pregnancy, good understanding of lifelong adherence and evidence of treatment success: two consecutive undetectable viral load measures)
Referred for high-resolution anoscopy

Exclusion criteria

Documented AIN (treated or untreated)
Local anal inflammation (proctitis) and/or acute fissure

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philip Roelandt, MD PhD	Universitaire Ziekenhuizen KU Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals Leuven		Leuven		3000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided