Hybrid Capture 2 Human Papiloma Virus (HPV) High-Risk Anal DNA Test

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a study to determine if HC2 HPV testing in the anal canal can detect high-risk HPV and whether this aids in identifying individuals are risk for anal cancer or precancerous lesions.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Anal Injury Screening for High Risk HPV

NCT04512508

Anal Injury Anal Cancer

UNKNOWN NA

New Strategies to Assess Anal Cancer Risk In Women

NCT02873741

Human Immunodeficiency Virus (HIV) Human Papillomavirus (HPV)

COMPLETED

Evaluation of Initial High Risk Human Papillomavirus (HR-HPV) Viral Load as Predictive Marker for Cervical Intraepithelial Neoplasia Grade 1 (CIN1) Persistence

NCT00682552

Cervical Intraepithelial Neoplasia

TERMINATED NA

Detecting HPV DNA in Anal and Cervical Cancers

NCT04857528

Cervical Cancer Anal Cancer HPV-Related Anal Squamous Cell Carcinoma +3 more

SUSPENDED

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.

NCT06574087

HPV-Related Carcinoma HPV Infection

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anal Canal HPV Infection Diagnosis Anal Dysplasia Diagnosis Anal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

swab and brush or swab and swab

we will determine which collection method is superior

Group Type EXPERIMENTAL

HC2 collection kit with a swab or brush

Intervention Type DEVICE

We will sample the anal canal for cells with either a swab and swab or swab and brush to determine which is superior

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HC2 collection kit with a swab or brush

We will sample the anal canal for cells with either a swab and swab or swab and brush to determine which is superior

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Qiagen HC2 HPV High-Risk DNA Test

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. male or female 18 years of age or older
2. screened for anal dysplasia, including MSM and women -

Exclusion Criteria

1. subject has had a previous treatment for anal cancer.
2. subjects that have used enemas or other foreign substances, in the anal canal or anal sex within 24 hours of collection.
3. subjects that have bleeding disorders or use anticoagulation treatments. -

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No