Clinical trial NCT06120205: SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening
Official title: SELF-CERV Pivotal Study: Method Comparison of Self-collection Using the Teal Wand Self-Collection Device and HCP (health Care Provider) Cervical Collection for Detection of High-risk HPV (hrHPV) for Cervical Cancer Screening
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hpv
HPV 16 Infection
HPV Infection
High Risk HPV
Keywords: screening
self-collect
HPV
cervical cancer screening
Lead sponsor: Teal Health, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 870
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The goal of this method comparison study is to compare the detection of hrHPV collected using the Teal Wand Self-Collection device to hrHPV detected from HCP (health care provider) cervical collection using primary HPV testing assays.

Participants will be asked to use the Teal Wand to provide a self-collected sample prior to a healthcare provider collected sample to be tested for hrHPV. Secondary measure will include usability and preferences.

Detailed description: To demonstrate that participants who are representative of the intended use population can understand the Instructions for Use (IFU) and appropriately use the Teal self-collection device to collect adequate vaginal cells/material for use in primary hrHPV screening (primary outcome).

To produce sufficient primary hrHPV test results following self-collection, as compared to the current SoC method of HCP specimen collection, when paired samples are tested using FDA approved primary hrHPV assays (Roche cobas and/or BD OnClarity).

Primary Effectiveness Objective

• To evaluate the performance of a self-collect device for hrHPV detection as compared to standard of care (SoC) by:

* Agreement of hrHPV self-collected sample(s) as compared to HCP-collected sample results.
* Calculating the invalid rate of tested samples.

Eligibility criteria: Group 1: Inclusion Criteria - General Population Group

1. Participant is 25 to 65 years of age and willing to provide informed consent.
2. Participant has an intact cervix.

Group 2: Inclusion Criteria - Enriched Population Group

1. Participant is 25 to 65 years of age and willing to provide informed consent.
2. Participant has an intact cervix.
3. One or more of the below:

   * Prior diagnosis of hrHPV within previous 6 months and/or
   * Positive cervical Pap cytology result (ASCUS, ASC-H, LSIL, HSIL, SCC, AIS) within previous 6 months and/or
   * Presenting for colposcopy/LEEP/excisional intervention

Exclusion Criteria - All Groups

1. Participant has impaired decision-making capacity or is unable to provide informed consent.
2. Participant has undergone partial or complete hysterectomy including removal of the cervix.
3. Participant on whom any form of cervical tissue alteration or surgery has been performed within the prior \< 5 months, including: conization, loop electrosurgical excision procedure (LEEP), laser ablative surgery, or cryotherapy.
4. Participant is pregnant (based on self-reporting).
5. Participant who reports or is experiencing menstrual bleeding.
6. Participant is participating in another clinical study for an investigational device, drug, or biologic that, in the investigator's opinion, would interfere with the results of this study.
7. Any medical reason that, in the investigator's judgment, would disqualify the participant for a routine pelvic exam with cervical sample collection.

Primary outcomes:
measure: Efficacy: Detection of hrHPV in self-collect and clinician collect samples
timeFrame: Samples tested within 7 days of collection
measure: Safety: SAE rate
timeFrame: 6-14 days following collections
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham OBGYN / Alabama Clinical Therapeutics
state: Alabama
city: San Francisco
country: United States
facility: Planned Parenthood Northern California
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: New Haven
country: United States
facility: Planned Parenthood Southern New England
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Baton Rouge
country: United States
facility: Woman's Hospital
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Planned Parenthood League of Massachusetts
state: Massachusetts
city: Saint Louis
country: United States
facility: Planned Parenthood St. Louis Region
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Mineola
country: United States
facility: New York University Langone Hospital
state: New York
city: Raleigh
country: United States
facility: Unified Women's Clinical Research Raleigh
state: North Carolina
city: Winston-Salem
country: United States
facility: Unified Women's Clinical Research - Lyndhurst
state: North Carolina
city: Houston
country: United States
facility: Planned Parenthood Gulf Coast
state: Texas
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
References: