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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 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
Cervical Biopsy
2012
Completed Phase 1
~10
Colposcopy
2009
Completed Phase 3
~64500
Excision
2017
N/A
~200
Biospecimen Collection
2004
Completed Phase 3
~2020
HPV Self-Collection
2022
N/A
~20

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,890 Previous Clinical Trials
41,022,369 Total Patients Enrolled
Vikrant V SahasrabuddhePrincipal InvestigatorNational Cancer Institute Division of Cancer Prevention
2 Previous Clinical Trials
1,020 Total Patients Enrolled
~300 spots leftby Feb 2025
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