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

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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