- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04423679
The Selfie Study- Assessing Novel Markers for Cervical Cancer Screening From Self-collected Samples (SELFIE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Worldwide, cervical cancer remains the fourth most common cancer and fourth leading cause of cancer deaths among women, with the greatest burden occurring in low-resource settings that lack effective screening and treatment. Even in the United States (U.S.), where Pap cytology screening has resulted in dramatic declines in cervical cancer incidence and mortality, thousands of new cases and related-deaths still occur every year, most commonly among underserved women who face barriers to accessing screening and/or treatment. The recent implementation of human papillomavirus (HPV) DNA testing as a primary strategy for cervical cancer screening has the potential to alleviate these disparities by improving the sensitivity for cervical precancer detection compared to Pap cytology, while providing greater long term reassurance following a negative HPV test. Moreover, HPV testing can be successfully performed on self-collected specimens, offering the possibility of expanding access to cervical cancer screening among hard-to-reach, underserved women.
Despite the many advantages of primary HPV screening, the current challenge is optimizing triage testing to determine who among the many women testing HPV positive are at high-risk and require immediate colposcopy referral or treatment, while avoiding unnecessary harms among women at low-risk. A molecular triage test that can be conducted from the same primary screening sample (i.e., reflex testing) is particularly attractive for both high-and low-resource settings, particularly if it works from self-collected samples. Previously, DNA methylation of candidate host cell genes has been evaluated in self-collected samples and achieved acceptable performance for triage of HPV-positive women. In studies using clinician collected samples, there is a suggestion that methylation of carcinogenic HPV genotypes has better clinical performance (higher sensitivity/specificity) compared to host gene methylation; however, HPV methylation has not been evaluated in self-collected specimens. Because HPV DNA is present in only a small subset of infected cells in the lower genital tract, particularly in cervical precancers, it is likely that the signal-to noise ratio in self-collected samples is better for HPV compared to host gene methylation, resulting in improved specificity for cervical precancer detection. Evaluating the feasibility of HPV DNA methylation testing from self-collected samples is essential for determining the extent to which this assay can address the critical need for HPV triage in high- and low resource settings. In collaboration with the Cancer Genome Research Laboratory, a high-throughput, low-cost next-generation bisulfite sequencing assay that detects methylation of the 12 most carcinogenic HPV genotypes has been developed. Further, this assay includes a panel of host genes, including those that have been previously evaluated in self-collected specimens. The proposal is to test this assay in paired self and clinician-collected samples from 1,000 women enrolled in an ongoing prospective study of women undergoing cervical cancer screening and colposcopy at the George Washington University (GWU). The hypothesis is that HPV and host DNA methylation will show non-inferior sensitivity and specificity for detection of cervical precancer in self-collected compared to clinician-collected samples and that HPV methylation will have higher absolute specificity compared to host methylation in both sample types.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nicole Chappell, MD
- Phone Number: 202 741 2434
- Email: nChappell@mfa.gwu.edu
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20037
- Recruiting
- Medical Faculty Associates
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Contact:
- Radwa Aly
- Email: raly@mfa.gwu.edu
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Principal Investigator:
- Nicole Chappell, M.D.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Female
- Age 30-69
- Undergoing cervical cancer screening, diagnostic procedure (colposcopy), or treatment (LEEP)
Exclusion Criteria:
- Pregnancy
- History of Cervical Cancer
- Prior hysterectomy
- Inability to provide informed consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
a standard brush-based cervicovaginal self-collection device
|
< 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).
|
a standard brush-based cervicovaginal self-collection device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluating the relative sensitivity and specificity of HPV methylation testing from collected samples
Time Frame: Up to 24 months
|
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
Time Frame: Up to 24 months
|
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
Time Frame: Up to 24 months
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Neoplasms, Squamous Cell
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
- Papilloma
Other Study ID Numbers
- NCR191015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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