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Virus Therapy

Self-Collection HPV Testing for Cervical Cancer Prevention

N/A

Recruiting

Led By Vikrant V Sahasrabuddhe

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Is 25 years or older

Willingness and ability to provide a documented informed consent

Must not have

Known history of excisional or ablative therapy to the cervix in the last 12 months prior to the referral visit

Has had a complete or partial hysterectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one-time, up to 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at using self-collected vaginal samples for HPV testing to improve cervical cancer prevention. HPV is a common virus that can lead to cervical cancer. Many people do not undergo regular screening for

Who is the study for?

This trial is for individuals who need a colposcopy or cervical excisional procedure and are interested in self-collecting vaginal samples for HPV testing to prevent cervical cancer. It's part of an initiative to make screening more accessible, especially for those who avoid traditional pelvic exams.

What is being tested?

The SHIP Trial evaluates the clinical accuracy of HPV testing on self-collected vaginal samples versus clinician-collected cervical samples. The goal is to inform FDA regulatory reviews of self-collection methods as alternatives for cervical cancer screening.

What are the potential side effects?

Since this study involves non-invasive sample collection and standard diagnostic procedures like biopsies, side effects may include discomfort or minor bleeding from the biopsy site, but no significant side effects are expected from the self-collection process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 25 years old or older.

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I am willing and able to sign a consent form.

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My cervix has not been removed.

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I am willing to undergo procedures to examine and treat my cervix.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery or treatment to remove part of my cervix in the last year.

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I have had a hysterectomy.

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I am experiencing unusual bleeding or pelvic pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one-time, up to 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one-time, up to 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and one-time, up to 90 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Clinical sensitivity for clinician-collected (CC) samples

Clinical sensitivity for self-collected (SC) samples

Clinical specificity for CC samples

+11 more

Other study objectives

Human factors affecting acceptability

Human factors affecting preferences for self-collection

Human factors affecting usability

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: Prevention (self-collected and clinician-collected samples)Experimental Treatment10 Interventions

Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with or without biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Excision

2017

N/A

~200

Cervical Biopsy

2012

Completed Phase 1

~10