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Procedure

Self-Collected Pap Smear for Cervical Cancer Screening (Pap Trial)

N/A
Recruiting
Led By John B Waits, MD
Research Sponsored by University of Alabama at Birmingham
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 baseline through 14 days
Awards & highlights

Pap Trial Summary

This trial will test whether a self-administered Pap smear is as accurate as one administered by a healthcare provider.

Who is the study for?
This trial is for women aged 21-65 in rural Alabama who are due for routine cervical cancer screening. It's not open to those with a history of cervical cancer, a positive Pap smear result, those who've had their uterus and cervix removed, or anyone in another cancer prevention study.Check my eligibility
What is being tested?
The study is comparing the effectiveness of self-administered Pap smears (Self-PAP) versus traditional Pap smears done by healthcare providers to see if they're equally accurate for cervical cancer screening.See study design
What are the potential side effects?
There are generally no side effects associated with either method of Pap smear testing. However, some individuals may experience mild discomfort or spotting after the procedure.

Pap Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate the self-PAP against the traditional Pap smear procedure

Pap Trial Design

2Treatment groups
Experimental Treatment
Group I: Traditional PapExperimental Treatment1 Intervention
Each patient will participate in both arms of the study on the day of the clinical examination. This arm includes the traditional, healthcare provider obtained Papanicolaou (Pap) smear specimen. They will be compared to each other for congruence and accuracy.
Group II: Self-PAPExperimental Treatment1 Intervention
Each patient will participate in both arms of the study on the day of the clinical examination. This arm includes the self-administered Papanicolaou (Pap) smear. They will be compared to each other for congruence and accuracy.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,594 Previous Clinical Trials
2,282,229 Total Patients Enrolled
Laboratory Corporation of AmericaIndustry Sponsor
28 Previous Clinical Trials
9,737 Total Patients Enrolled
Cahaba Medical Care FoundationOTHER

Media Library

Self-PAP (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04093388 — N/A
Cervical Cancer Research Study Groups: Self-PAP, Traditional Pap
Cervical Cancer Clinical Trial 2023: Self-PAP Highlights & Side Effects. Trial Name: NCT04093388 — N/A
Self-PAP (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04093388 — N/A
Cervical Cancer Patient Testimony for trial: Trial Name: NCT04093388 — N/A
~34 spots leftby Dec 2024
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