Human PapillomavirusNCT06434337
Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV)
An observational study of Human Papillomavirus, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Human Papillomavirus
- What is being tested?
- Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test")
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2024to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: MD Anderson Cancer Center
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Kathleen Schmeler, MD, 713-745-3518, kschmele@mdanderson.org
Kathleen Schmeler, MD
About this study
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.
Read the detailed description
Primary Objectives
- To evaluate the performance of 3 versions of a novel point-of-care diagnostic test for detecting HPV ("Rice HPV test").
Secondary Objectives
- To evaluate the results of the Rice HPV test with corresponding pathology results to assess the association of HPV test results with the presence of high-grade cervical dysplasia (CIN 2+).
- To assess how different sample processing methods affect the performance of the Rice HPV test.
- To assess how different test readout methods affect the performance of the Rice HPV test.
Exploratory Objectives
- Compare the performance of the Rice HPV test between provider-collected and self-collected samples.
- Conduct a survey on participant experiences with self-sampling to assess whether participants prefer self-sampling over provider-collected sampling.
- Compare the performance of the Rice HPV test to other benchmark HPV tests such as GeneXpert.
- Conditions
- Human Papillomavirus
- Being tested
- Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test")
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test")Diagnostic test
Given by Diagnostic Test
| Study group | Role | What they receive |
|---|---|---|
| Research Group | Standard-of-care (SOC) procedures will be performed as part of the routine visit, and the provider will collect up to two additional cervical swabs for research. One research cervicovaginal swab may also be self-collected by the patient (optional procedure) in the clinic during the routine visit. All research swab samples, in addition to residual material from standard of care HPV testing, will be transferred to Rice University team for testing and some will be tested on site at the provider facility as described below. Receives: Diagnostic Test: Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test") |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start23 Jul 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human PapillomavirusStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen Schmeler, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434337
- Sponsor's protocol ID
- 2024-0020
- Other IDs
- NCI-2024-04598
- Status last verified
- May 2026
- First submitted
- 23 May 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV)
- ClinicalTrials.gov ID
- NCT06434337
- Acronym / sponsor ID
- 2024-0020
- Conditions
- Human Papillomavirus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objectives
- To evaluate the performance of 3 versions of a novel point-of-care diagnostic test for detecting HPV ("Rice HPV test").
Secondary Objectives
- To evaluate the results of the Rice HPV test with corresponding pathology results to assess the association of HPV test results with the presence of high-grade cervical dysplasia (CIN 2+).
- To assess how different sample processing methods affect the performance of the Rice HPV test.
- To assess how different test readout methods affect the performance of the Rice HPV test.
Exploratory Objectives
- Compare the performance of the Rice HPV test between provider-collected and self-collected samples.
- Conduct a survey on participant experiences with self-sampling to assess whether participants prefer self-sampling over provider-collected sampling.
- Compare the performance of the Rice HPV test to other benchmark HPV tests such as GeneXpert.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research Group | – | Diagnostic Test: Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test")Standard-of-care (SOC) procedures will be performed as part of the routine visit, and the provider will collect up to two additional cervical swabs for research. One research cervicovaginal swab may also be self-collected by the patient (optional procedure) in the clinic during the routine visit. All research swab samples, in addition to residual material from standard of care HPV testing, will be transferred to Rice University team for testing and some will be tested on site at the provider facility as described below. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MD Anderson Cancer Center
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test")Given by Diagnostic Test | Diagnostic test | Research Group |
Primary outcome
Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test")
Time frame: Through study completion; an average of 1 year
To evaluate the performance of the 3 version of a novel point-of-care diagnostic test for detecting HPV ("Rice HPV test").
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathleen Schmeler, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathleen Schmeler, MD ((713) 745-3518, kschmele@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test") (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.