Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age21+
SponsorM.D. Anderson Cancer Center

About this trial

To learn if new HPV tests can provide the same results as standard HPV tests. The findings from this study may aid in the development of new HPV tests that require less equipment and are more accessible.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

People with a cervix 21 years of age or older.

Scheduled to undergo hrHPV testing at MD Anderson and The Harris Health System (LBJ Hospital) according to national and institutional guidelines at time of enrollment OR are anticipated to undergo a LEEP, ECC, or biopsy.

Willing and able to provide informed consent.

Able to perform protocol-required activities. Able to speak and read English or Spanish.

Disqualifiers

Patient or provider decision not to perform HPV testing. This does not apply to patients that are undergoing either a LEEP, ECC or biopsy.

Participant or provider decision not to collect a sample for this study.

Participants that are pregnant.

Trial population

MD Anderson Cancer Center

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

  • Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test")

    Diagnostic test

    Given by Diagnostic Test

Treatment groups

600 Participants
are divided into 1 treatment group
Group A: Research Group1 intervention

Trial outcomes

Primary outcomes

1

Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test")

To evaluate the performance of the 3 version of a novel point-of-care diagnostic test for detecting HPV ("Rice HPV test").

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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