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Completed

NCT Number: NCT04746872

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

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.

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Key information

Conditions

Human Papillomavirus Infections Neoplasms Virus Diseases

Age range

25 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Alabama at Birmingham Hospital, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alinity m HR HPV

Diagnostic Test

A qualitative in vitro test that amplifies and detects HR HPV DNA in cervical tissue samples.

Primary outcomes

  1. Disease Progression greater than or equal to (cervical intraepithelial neoplasia) CIN3

    Time frame: Baseline to 12 weeks

    Diagnosis of greater than or equal to CIN3 (cervical intraepithelial neoplasia) is based on central pathology review panel histologic result.

Secondary outcomes

  1. Disease progression greater than or equal to cervical intraepithelial neoplasia (CIN2)

    Time frame: Baseline to 12 weeks

    Diagnosis of greater than or equal to CIN2 (cervical intraepithelial neoplasia) is based on central pathology review panel histologic result.

Sponsors and collaborators

Lead sponsor

Abbott Molecular

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 10, 2021
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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