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Diagnostic Test

HPV Self-Sampling for Cervical Cancer Screening

N/A
Waitlist Available
Led By Kathy MacLaughlin, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up anticipate 6-8 months to collect number of samples needed
Awards & highlights

Study Summary

This trial will test a self-sampling vaginal collection kit to see if it accurately detects HPV infection, compared to usual healthcare provider-collected samples.

Who is the study for?
This trial is for women visiting the Mayo Clinic Rochester's Gynecology or Colposcopy Clinics who are due for a speculum exam, like cervical cancer screening or IUD insertion. It's not for those with heavy bleeding at visit time, currently menstruating, recently pregnant, without a cervix, having abnormal discharge, undergoing LEEP procedures, or using certain vaginal creams.Check my eligibility
What is being tested?
The study tests if women can accurately self-sample for HPV using a swab kit (Evalyn brush) compared to clinician-collected samples. The goal is to see if self-sampling could be an effective way to screen for cervical cancer and other HPV-related conditions.See study design
What are the potential side effects?
There may be minimal side effects from using the Evalyn brush swab kit such as discomfort during sample collection. However, since it involves standard procedures similar to regular HPV testing methods used by healthcare providers, significant side effects are unlikely.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~anticipate 6-8 months to collect number of samples needed
This trial's timeline: 3 weeks for screening, Varies for treatment, and anticipate 6-8 months to collect number of samples needed for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Human papilloma virus infection
Secondary outcome measures
Patient-reported acceptability and feasibility of using the Evalyn brush

Trial Design

1Treatment groups
Experimental Treatment
Group I: Self-collected vaginal swab samplesExperimental Treatment2 Interventions
Subjects will self-collect a vaginal swab (Evalyn brush) and complete a scheduled standard of care clinician-collected cervical swab

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,757,926 Total Patients Enrolled
Kathy MacLaughlin, MDPrincipal InvestigatorMayo Clinic

Media Library

Clinician-collection of cervical sample for HPV testing (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT05600283 — N/A
Human Papillomavirus Research Study Groups: Self-collected vaginal swab samples
Human Papillomavirus Clinical Trial 2023: Clinician-collection of cervical sample for HPV testing Highlights & Side Effects. Trial Name: NCT05600283 — N/A
Clinician-collection of cervical sample for HPV testing (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05600283 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can participants aged fifty or above join this research project?

"This study seeks participants who are aged between 25 and 65. For those seeking medical trials outside of this age range, there are 27 studies specifically for minors and 328 trials designed to accommodate seniors."

Answered by AI

Do I meet the eligibility requirements to take part in this experiment?

"This research project requests 125 individuals aged 25 to 65 who have human papillomavirus. Participants must also secure an appointment at Mayo Clinic Rochester in Gynecology Colposcopy or ICS (Integrated Community Specialty) Colposcopy Clinics, both of which necessitate a speculum exam. Additionally, appointments with the same requirement can be made through the Mayo Clinic's Gynecology Department for indications such as cervical cancer screening and intrauterine device insertion."

Answered by AI

Are there any openings still left for participants in this experiment?

"The details available on clinicaltrials.gov suggest that recruitment for this trial has ended; the medical study was first posted in November of 2022, and its last edit was made two weeks after. However, 389 other trials are presently recruiting patients."

Answered by AI
~25 spots leftby Jul 2024