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Virus Therapy

HPV Self-Collection for Cervical Cancer Prevention (SHIP-A-S01 Trial)

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

Has had a referral for colposcopy and/or cervical excisional procedure in which routine cervical cancer screening has included HPV testing (HPV primary screening, co-testing, or atypical squamous cells of undetermined significance [ASC-US] cytology triage) or abnormal cytology performed within the past 12 months preceding the referral visit

Is 25 years or older

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 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?

The SHIP Trial is for individuals who need a colposcopy or cervical excisional procedure and are interested in self-collecting vaginal samples for HPV testing. This trial aims to improve cervical cancer prevention by offering an alternative to traditional pelvic exams.

What is being tested?

This study tests the clinical accuracy of HPV testing on self-collected vaginal samples versus those collected by clinicians. It's part of efforts to increase access to screening and inform FDA reviews of self-collection methods for detecting cervical cancer risks.

What are the potential side effects?

There may be minimal side effects related to this trial, primarily discomfort from collecting one's own sample or undergoing standard procedures like biopsies if needed. The main focus is on comparing sample collection methods.

Eligibility Criteria

Inclusion Criteria

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

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

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I am 25 years old or older.

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My cervix has not been removed.

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 Treatment10 Interventions

Patients undergo self-collection of two vaginal samples and then undergo clinician-collection of a cervical test sample. Patients then undergo standard of care colposcopy with 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

~2020

Colposcopy

2009

Completed Phase 3

~64500