## Protocol Section
### Identification Module
**NCT ID:** NCT06434337

**Brief Title:** Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV)

**Official Title:** Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV)

#### Organization Study ID Info
**ID:** 2024-0020
#### Organization
**Class:** OTHER
**Full Name:** M.D. Anderson Cancer Center
#### Secondary ID Infos
**Domain:** NCI-CTRP Clinical Registry
**ID:** NCI-2024-04598
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2028-03-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-03-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-11-29

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** M.D. Anderson Cancer Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**Detailed Description:** Primary Objectives

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

Secondary Objectives

1. 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+).
2. To assess how different sample processing methods affect the performance of the Rice HPV test.
3. To assess how different test readout methods affect the performance of the Rice HPV test.

Exploratory Objectives

1. Compare the performance of the Rice HPV test between provider-collected and self-collected samples.
2. Conduct a survey on participant experiences with self-sampling to assess whether participants prefer self-sampling over provider-collected sampling.
3. Compare the performance of the Rice HPV test to other benchmark HPV tests such as GeneXpert.

### Conditions Module

**Conditions:**

- Human Papillomavirus

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 600

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants that agree to take part in this study, then 2 additional cervical swabs will be collected for research purposes during a routine clinical visit. The leftover material from the routine HPV test will also be collected under this study.

**Intervention Names:**

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

**Label:** Standard-of-care (SOC)

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Standard-of-care (SOC)

**Description:** Given by Diagnostic Test

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

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** To assess the evaluation for the performance of the 3 verisions of a novel point of care diagnostic test for detecting hpv (rice hpv test)

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

**Time Frame:** Through study completion; an average of 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. People with a cervix 21 years of age or older.
2. 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.
3. Willing and able to provide informed consent.
4. Able to perform protocol-required activities. Able to speak and read English or Spanish.

Exclusion Criteria

1. Participant or provider decision not to perform HPV testing.
2. Participant or provider decision not to collect a sample for this study.
3. Participants that are pregnant.

**Minimum Age:** 21 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** MD Anderson Cancer Center

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** kschmele@mdanderson.org

**Name:** Kathleen Schmeler, MD

**Phone:** (713) 745-3518

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Houston

**Contacts:**

***Contact 1:***

- **Email:** kschmele@mdanderson.org

- **Name:** Kathleen Schmeler, MD

- **Phone:** 713-745-3518

- **Role:** CONTACT

***Contact 2:***

- **Name:** Kathleen Schmeler, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** MD Anderson Cancer Center

**State:** Texas

**Zip:** 77030

#### Overall Officials

**Official 1:**

**Affiliation:** M.D. Anderson Cancer Center

**Name:** Kathleen Schmeler, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### See Also Links

**Label:** MD Anderson Cancer Center

**URL:** http://www.mdanderson.org

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
