The Selfie Study- Assessing Novel Markers for Cervical Cancer Screening From Self-collected Samples

NCT04423679 | Completed

• 1 other identifier: NCR191015
• Study Type: observational
• Target: 294
• Locations: 1 country
• Sites: 1

Brief Summary

Cervical cancer is primarily caused by Human Papillomaviruses (HPV). Testing for HPV in cervical samples is now an option for cervical cancer screening. HPV can also be tested from self-collected samples which may help to improve access to screening, since it does not require a doctor visit. However, many women will test positive for HPV who are not at high risk for cervical cancer. Therefore, additional ("triage") tests are needed to determine which women testing HPV-positive require additional clinical workup. For self sampling, a triage test that could be measured from the same initial sample without requiring a follow-up visit to the doctor would be an ideal strategy. The purpose of this study is to determine whether a new HPV test that measures changes in HPV DNA can be used to triage HPV-positive women using self collected samples. This study will enroll 1,000 women who are undergoing cervical cancer screening at the George Washington University. Women will be asked to take a self-collected sample prior to their clinic visit. The investigators will evaluate the clinical accuracy of the new HPV triage test in self-collected samples and compare the accuracy of the test in samples collected by the clinician.

Conditions

Human Papilloma Virus; Cervical Cancer; CIN 2/3

Outcome Measures

Primary Outcomes (3)

• Evaluating the relative sensitivity and specificity of HPV methylation testing from collected samples

  Evaluate the relative sensitivity and specificity of HPV methylation testing from self-collected compared to clinician-collected samples for detection of cervical precancer.

  Up to 24 months

• Evaluating the relative sensitivity and specificity of host gene methylation testing from collected samples

  Evaluate the relative sensitivity and specificity of host gene methylation testing from self-collected compared to clinician-collected samples for detection of cervical precancer.

  Up to 24 months

• Comparing the absolute sensitivity and specificity of HPV versus host gene methylation testing

  Compare the absolute sensitivity and specificity of HPV versus host gene methylation testing for the detection of cervical pre-cancer in both self-collected and clinician-collected samples

  Up to 24 months

Study Arms (2)

CIN2+

Cases of cervical precancer will include women diagnosed with cervical intraepithelial grades 2 or 3 (CIN2/3) or adenocarcinoma in situ (AIS). If any women are diagnosed with cancer in the study, they will be included in this group.

Device: Evalyn Brush

< CIN2

Non-cases will include those with \<CIN2 on colposcopy/biopsy and women who did not have an indication for colposcopy (because of a negative screening test).

Device: Evalyn Brush

Interventions

Evalyn Brush DEVICE

a standard brush-based cervicovaginal self-collection device

< CIN2; CIN2+

Eligibility Criteria

• Age: 30 Years - 69 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women undergoing routine screening with Pap cytology and HPV testing or colposcopy at the George Washington University (GWU). From this population, a representative subset of 1000 women for self-sampling and methylation testing (400 cases and 600 controls). Most controls will come from the screening population, where we expect 85% to have negative HPV and cytology results. The majority of cases will come from the colposcopy referral population. Cases of cervical precancer will include women diagnosed with cervical intraepithelial grades 2 or 3 (CIN2/3) or adenocarcinoma in situ (AIS). If any women are diagnosed with cancer in the study, they will be included in the case group (CIN2+); however, we will also perform sensitivity analyses excluding these women. Non-cases will include those with less than CIN2 on colposcopy/biopsy and women who did not have an indication for colposcopy (because of negative screening).

You may qualify if:

• Female
• Age 30-69
• Undergoing cervical cancer screening, diagnostic procedure (colposcopy), or treatment (LEEP)

You may not qualify if:

• Pregnancy
• History of Cervical Cancer
• Prior hysterectomy
• Inability to provide informed consent

Sponsors & Collaborators

• Sarasota Memorial Health Care System: collaborator
• George Washington University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: June 9, 2020
• Study Start: August 15, 2020
• Primary Completion: April 24, 2025
• Study Completion: June 19, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)