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Virus Therapy

HPV Self-Collection 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

Has an intact cervix

Must not have

Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records

Is experiencing unusual bleeding or pelvic pain

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one-time, up to 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test if self-collected vaginal samples can be used for HPV testing to improve cervical cancer prevention. HPV is a virus that can cause cervical cancer, but many people are not diagnosed early

Who is the study for?

This trial is for individuals referred for colposcopy or cervical excisional procedures to prevent cervical cancer. Participants will use self-collection kits for HPV testing, which could offer more comfort and flexibility than traditional clinic-based tests.

What is being tested?

The SHIP Trial evaluates the clinical accuracy of HPV testing using self-collected vaginal samples versus clinician-collected cervical samples. It aims to inform FDA regulatory reviews of these self-collection methods for cervical cancer screening.

What are the potential side effects?

There are generally no direct side effects from participating in this study as it involves non-invasive collection of samples. However, some individuals might experience discomfort or emotional distress during self-sampling.

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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My cervix has not been removed.

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I was referred for a colposcopy or cervical procedure after an abnormal cervical cancer screening in the last year.

Exclusion Criteria

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

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I have had a hysterectomy, either partial or complete.

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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 references 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 Treatment9 Interventions

Patients undergo self-collection of a vaginal sample and then undergo clinician-collection of a cervical test sample. Patients then undergo SOC colposcopy with cervical biopsy/endocervical curettage and/or cervical excisional procedures as clinically indicated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

Colposcopy

2009

Completed Phase 3

~64500