What side effects are associated with this type of intervention?

Common treatments for Human Papillomavirus (HPV) infections, particularly those related to genital warts, include imiquimod, podofilox, and sinecatechins. Imiquimod can cause local skin reactions such as redness, swelling, erosion, and itching. Podofilox may lead to mild to moderate pain, burning, inflammation, and erosion at the application site. Sinecatechins can cause erythema, pruritus, burning, pain, and ulceration. These side effects are generally localized to the area of application and are manageable with proper medical guidance.

What prior FDA approvals exist?

The FDA has approved several treatments for HPV-associated conditions, particularly cervical cancer. Notable approvals include the HPV vaccines (such as Gardasil and Cervarix) which prevent infection with high-risk HPV types. For treatment, the FDA has approved drugs like pembrolizumab (Keytruda) for advanced cervical cancer, particularly in cases where tumors express PD-L1. Additionally, the FDA has approved the use of topical agents like imiquimod for treating vulvar intraepithelial neoplasia, a condition often caused by HPV. These treatments are part of a broader strategy to manage and prevent HPV-related diseases, complementing screening efforts such as those facilitated by self-collection devices.

What other types of research exist?

Promising alternatives to self-collection devices for HPV patients in 2024 include: 1) Liquid-based cytology methods, which improve the accuracy of cytodiagnosis, 2) HPV testing combined with cytology for more comprehensive risk assessment, and 3) Expedited treatment options like loop electrosurgical excision procedure (LEEP) for high-risk patients. Additionally, the use of management guidelines applications by the American Society for Colposcopy and Cervical Pathology (ASCCP) can aid in personalized patient management.

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Device

Self-Screening Device for Cervical Cancer

N/A

Waitlist Available

Led By Megan Fitzpatrick, MD

Research Sponsored by Teal Health, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new tool that lets women collect their own samples from the cervix and vagina at home. It targets women who need screening for a virus that can cause cervical cancer. The samples are sent to a lab for testing. Self-collection of cervico-vaginal samples for human papillomavirus (HPV) testing has been shown to increase participation in cervical cancer screening among underscreened women.

Who is the study for?

This trial is for women aged 25 to 65 with an intact cervix who can consent. It's open to those without current menstruation, not pregnant, and haven't used certain cervical products recently. Women with a history of high-risk HPV or abnormal cytology results are also eligible.

What is being tested?

The study is testing a new self-collection device by Teal Health for cervical cancer screening. Participants will use the device themselves to collect samples that will be evaluated for effectiveness in detecting potential cancer indicators.

What are the potential side effects?

Since this trial involves a non-invasive collection device, side effects may be minimal but could include discomfort or slight bleeding during or after sample collection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ acute - immediately after self-collection procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~acute - immediately after self-collection procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and acute - immediately after self-collection procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Effectiveness: Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)

Primary Effectiveness: Sample Inadequacy Rate

Primary Safety: SAEs

Secondary study objectives

Rate of sample adequacy for liquid-based cytology analysis

Satisfaction and Needs Survey

Usability Survey

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Teal Health Self-Collection Device GroupExperimental Treatment1 Intervention

This group will use the Teal Health Self-Collection Device to evaluate the instructions for use, usability, and satisfaction with the self-collection device. Participants will also undergo a Pap smear performed by a clinician. Self-collected and clinician-collected research samples will undergo HPV testing and cytological analysis using tests that are FDA-approved for use for HPV and Pap cytology.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Human Papillomavirus (HPV) include topical agents such as imiquimod, which boosts the body's immune response to combat the virus, and cidofovir, which inhibits viral DNA synthesis. These treatments are significant for HPV patients as they help manage the infection and reduce the risk of progression to cervical cancer. Additionally, HPV vaccination plays a critical role in preventing infection from the most common cancer-causing strains of the virus, thereby reducing the overall incidence of cervical cancer.

Head and neck cancer: from research to therapy and cure.Treatment of human papillomavirus gynecologic infections.