NCT04585243

Brief Summary

This study seeks to compare the accuracy and acceptability of HPV testing self-sampling kit and standard clinician-sampling for HPV testing. The primary outcome of this study is the concordance between screening results on self-sampling kits compared to clinician-collected HPV test, Pap smear results, and colposcopy. Secondary endpoints will include acceptability of self-sampling and barriers to cervical cancer screening. These endpoints will be analyzed to try to circumvent barriers to the cervical cancer screening and ascertain whether self-sampling is a viable alternative.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

December 9, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2022

Completed
12 months until next milestone

Results Posted

Study results publicly available

September 22, 2023

Completed
Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

1.8 years

First QC Date

October 2, 2020

Results QC Date

August 25, 2023

Last Update Submit

October 4, 2023

Conditions

HPV

Keywords

HPVSelf-SamplingColposcopyCervical cancerCancer screening

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Concordance of Screening Results of the Self-Sampling Kit Compared to Clinician-collected Samples

    The primary outcome of this study is to analyze the number of participants with concordance of screening results of the self-sampling kit compared to clinician-collected HPV test, Pap smear results, and colposcopy.

    Within two weeks of their colposcopy exam.

Secondary Outcomes (2)

  • Number of Completed Self-Sampling Kits

    Within two weeks of their colposcopy exam.

  • Number of Participants Who Reported Problems Using Self-Sampling Kits

    Within two weeks of their colposcopy exam

Study Arms (1)

Self-Sampling Kit

EXPERIMENTAL

Participants will be mailed a Self-Sampling kit (Evalyn Brush) to collect samples for analysis for HPV/Cervical cancer screening.

Device: Evalyn Brush

Interventions

Evalyn BrushDEVICE

The Evalyn Brush is a self-sampling kit that can be used to collect a sample to screen for HPV/Cervical cancer at home.

Self-Sampling Kit

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Penn State Health Patient
  • Has an intact cervix
  • Found to have abnormal findings on Pap/HPV test that requires a colposcopy
  • Speaks, read, or writes well in English or Spanish

You may not qualify if:

  • Pregnant
  • Cognitively impaired
  • Incarcerated
  • Complete hysterectomy
  • History of cervical treatment for abnormal Pap/HPV test (i.e. cryotherapy, loop electrosurgical excision procedure (LEEP))

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jennifer Moss

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (5)

  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.

    PMID: 29313949BACKGROUND

  • Shieh Y, Eklund M, Sawaya GF, Black WC, Kramer BS, Esserman LJ. Population-based screening for cancer: hope and hype. Nat Rev Clin Oncol. 2016 Sep;13(9):550-65. doi: 10.1038/nrclinonc.2016.50. Epub 2016 Apr 13.

    PMID: 27071351BACKGROUND

  • U. S. Preventive Services Task Force. Final recommendation statement: Cervical cancer: Screening; 2018. https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/cervical-cancer-screening2. Accessed 2018.

    BACKGROUND

  • Saslow D, Solomon D, Lawson HW, Killackey M, Kulasingam SL, Cain J, Garcia FA, Moriarty AT, Waxman AG, Wilbur DC, Wentzensen N, Downs LS Jr, Spitzer M, Moscicki AB, Franco EL, Stoler MH, Schiffman M, Castle PE, Myers ER; ACS-ASCCP-ASCP Cervical Cancer Guideline Committee. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin. 2012 May-Jun;62(3):147-72. doi: 10.3322/caac.21139. Epub 2012 Mar 14.

    PMID: 22422631BACKGROUND

  • Wong A, Morgis R, Entenman J, Ramirez SI, Hays AL, Wright TS, Scartozzi CM, Ruffin MT, Moss JL. Exploratory Analysis of Concordance Between Clinician-Collected and Self-Sampled Human Papillomavirus Tests in a Small Cohort of Average- and High-Risk Patients. Womens Health Rep (New Rochelle). 2024 Mar 13;5(1):259-266. doi: 10.1089/whr.2024.0004. eCollection 2024.

    PMID: 38516651DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Limitations and Caveats

small sample size due to slow participant accrual, exclusion of patients who do not engage in health care (group most likely to benefit from self-sampling)

Results Point of Contact

Title
Jennifer L. Moss, PhD
Organization
Pennsylvania State University College of Medicine
jmoss1@pennstatehealth.psu.edu
717-531-0003

Study Officials

  • Jennifer Moss, PhD

    Penn State College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Participants who enroll in the study will be asked to complete an HPV self-sampling kit in addition to completing their colposcopy exam. Participants will collect the sample at home before or after their exam and mail it back to the Penn State Health laboratory for analysis. The results will be compared to those of the clinician-collected (standard of care) colposcopy exam, Pap, and HPV test. Participants will also complete a follow up survey over the phone after their sample is collected.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 2, 2020

First Posted

October 14, 2020

Study Start

December 9, 2020

Primary Completion

September 30, 2022

Study Completion

October 5, 2022

Last Updated

October 11, 2023

Results First Posted

September 22, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)