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

NCT04746872 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 14935

Last updated 2024-02-12

No results posted yet for this study

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.

Conditions

  • Human Papillomavirus

Interventions

DIAGNOSTIC_TEST

Alinity m HR HPV

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

Sponsors & Collaborators

  • Abbott Molecular

    lead INDUSTRY

Eligibility

Min Age
25 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-16
Primary Completion
2022-06-16
Completion
2022-11-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04746872 on ClinicalTrials.gov