Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening

Study Overview
=================
Brief Summary
-----------------
A prospective multicenter interventional study will be conducted to enroll women undergoing routine cervical cancer screening to collect cervical liquid-based cytology (LBC) specimen(s). For all subjects, two cervical specimens will be collected, and one placed into Hologic ThinPrep Pap Test collection kit with PreservCyt Solution (also referred to as ThinPrep specimen) and the other into BD SurePath liquid-based Pap test (also referred to as SurePath specimen). Cytology and HR HPV results will be generated and utilized to determine need for subject referral to colposcopy. Collection of an endocervical curettage (ECC) specimen, and biopsy(ies) if applicable, from women who are referred to colposcopy as a follow up will be conducted according to a standardized protocol. Disease status for each subject will be determined based on cytology, HPV test results, and/or consensus histology review of cervical biopsy specimens.

Official Title
-----------------
Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening

Conditions
-----------------
Human Papillomavirus

Intervention / Treatment
-----------------
* Device: Alinity m HR HPV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women is eligible if she meets the following: Is 25 years of age or older Is attending a participating clinic for routine cervical cancer screening following screening guidelines Has an intact cervix Is willing and able to provide documented informed consent Is willing and able to undergo colposcopy, biopsy, and endocervical curettage (ECC) within 12 weeks (≤ 84 days) from the baseline visit, if required Is willing and able to allow collection of two cervical cytology specimens Exclusion Criteria: A women is ineligible for the study if she meets any of the following criteria: Is pregnant at the time of visit or plans to become pregnant within the following 12 weeks Has any known medical condition that, in the opinion of the investigator, would result in increased risk of bleeding at biopsy Has a known history of excisional or ablative therapy (e.g., LEEP, cone biopsy, cervical laser surgery, or cryotherapy) to the cervix in the last 12 months prior to the baseline visit Had a cervical cytology specimen collected within the last 4 months Is currently participating in any diagnostic trial for cervical cancer Had a complete or partial hysterectomy, either supra cervical or involving removal of the cervix Is currently participating or planning to participate in any clinical trial for HPV treatment (for the duration of this study) Previous participation in this study

Ages Eligible for Study
-----------------
Minimum Age: 25 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alinity m HR HPV<br>The Alinity m HR HPV IUO assay is a qualitative in vitro test that amplifies and detects HR HPV DNA in cervical cells collected in liquid media. The assay can differentiate between HPV 16, HPV 18, HPV 45 and non-HPV 16/18/45 genotypes [(31/ 33/ 52/ 58) and (35/ 39/ 51/ 56/ 59/ 66/ 68)]. | Device: Alinity m HR HPV<br>* Alinity m HR HPV<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Progression greater than or equal to (cervical intraepithelial neoplasia) CIN3 | Diagnosis of greater than or equal to CIN3 (cervical intraepithelial neoplasia) is based on central pathology review panel histologic result. | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression greater than or equal to cervical intraepithelial neoplasia (CIN2) | Diagnosis of greater than or equal to CIN2 (cervical intraepithelial neoplasia) is based on central pathology review panel histologic result. | Baseline to 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HPV, Virus, Cervical, Cancer, Oncology, Screening, tissue collection, biopsy