← Back to Search

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

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
Select...
I was referred for a colposcopy or cervical procedure after an abnormal cervical cancer screening in the last year.
Select...
I am 25 years old or older.
Select...
My cervix has not been removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a hysterectomy, either partial or complete.
Select...
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
Clinical specificity
FNR ratio
+7 more
Other study objectives
Human factors affecting acceptability
Human factors affecting references for self-collection
Human factors affecting usability

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prevention (self-collected and clinician-collected samples)Experimental Treatment9 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
Excision
2017
N/A
~200
HPV Self-Collection
2022
N/A
~20
Cervical Biopsy
2012
Completed Phase 1
~10
Biospecimen Collection
2004
Completed Phase 3
~2020
Colposcopy
2009
Completed Phase 3
~64500

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,480 Total Patients Enrolled
Vikrant V SahasrabuddhePrincipal InvestigatorNational Cancer Institute Division of Cancer Prevention
~208 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top