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Clinical, Translational and Biomarker-Based Female Genital HPV Induced Dysplasia and Cancer Screening Study Using Cf-HPV-DNA Blood Tests

NCT05536843 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2022-09-13

No results posted yet for this study

Summary

Uterine cervical dysplasia and other female genital dysplasia continue to be significant health problems despite Cervical Screening Programs and HPV vaccinations being available. These female genital dysplasia \[FGD\] induced by HPV infections affect disadvantaged women in the US and globally more than others: minorities like African Americans \[AA\], rural populations, lower socioeconomic strata of the society and less educated in the US and lower / middle income countries. The reasons are: lack of access to screening and vaccines, lack of infrastructure, fear and shame of getting a pelvic examination and pap's smear and inability to go to the health centers that provide these cares. A simple blood test that can diagnose FGD can help make many of those hurdles go away. This proposal is to utilize the emergence of 'liquid biopsy' concepts using genomic/precision medicine advances of the past decade to have such a blood test to be made available. Collaborating with Naveris, Inc,® the clinical study will use their NavDx® blood test. This is a test for circulating cell-free tumor tissue modified viral (TTMV®)-HPV DNA. TTMV-HPV DNA is a clinically proven and analytically validated highly sensitive and specific biomarker for the identification of post-treatment recurrent and residual Human Papillomavirus (HPV)-driven squamous cell oropharyngeal carcinoma (OPSCC)1,2. Data is accruing for other major HPV-driven cancers including anal cancer and uterine cervical cancer with clinical utility appear similarly promising3. TTMV-HPV DNA is a distinct biomarker for HPV-driven malignancy and can distinguish between HPV-driven malignancy and acute and or chronic HPV infection. In this study, taking advantage of a robust Cervical Dysplasia Clinic in existence at UMMC and a team of multidisciplinary experts focused on this project, the blood levels of TTMV-HPV DNA will be determined through a fully informed IRB approved clinical trial process to correlate with the grades of dysplasia, any increasing values correlating with worsening grade/malignant transformation and other variables. This pilot study is the first of this type of biomarker-based 'screening' study, and if successful, will lead to a more efficient and convenient way to diagnose HPV-induced that will be cost effective and will need minimal infrastructure. Such a test will make remarkable beneficial differences in early diagnosis, early screening compliance, early interventions as well as improving outcomes in FGD patients worldwide. With the available infrastructure and expert team, this project can be successfully completed in a relatively short time.

Conditions

  • Cervical Dysplasia, Uterine
  • Vaginal Dysplasia
  • Vulvar Dysplasia

Sponsors & Collaborators

  • University of Mississippi Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2023-12-31
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05536843 on ClinicalTrials.gov