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

NCT05536843 | Unknown

• 1 other identifier: UMississippiRadOnc
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

HPV; Dysplasia; Liquid Biopsy; Screening; Female Genital Cancer

Outcome Measures

Primary Outcomes (1)

• CORRELATION BETWEEN BLOOD BASED 'LIQUID BIOPSY' BIOMARKER TO TISSUE DIAGNOSIS

  Correlate the detectable levels of TTMV-HPV-DNA with demographics, grades of dysplasia, progression in the grades with serial measurements and HIV status and correlate with biopsy results in terms of progression in PIN grades and malignant transformation. Given the pilot nature of the proposed study, extensive use of exploratory data analysis will be done. For any analysis of time-to-event data,Kaplan-Meier analyses paired with two-sided log-rank tests will be used. For any necessary modeling, a generalized linear model framework will be employed with appropriate family and link functions, depending on the outcome. Should independence fail between the sampling units (repeated measures, etc.), this will be extended to generalized linear mixed models with random intercepts. All linearity assumptions will be checked and modifications to modeling strategies will be undertaken where necessary."

  1 year

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Adult women with female genital dysplasia; Non pregnant women; No prisoners; Competent to give informed consent
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult non-pregnant women diagnosed with female genital dysplasia at the University of Mississippi Medical Center

You may qualify if:

• Adult women with female genital dysplasia
• Non pregnant women
• No prisoners
• age in between 18 years and 100 years
• Competent to give informed consent

You may not qualify if:

• Pregnant women
• Female below 18 years
• Prisoners

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Biospecimen

Retention: SAMPLES WITH DNA

1. Blood collection from the subject vein by UMMC's trained professionals of about four table spoons of blood like for any other blood test. 2. The samples collected will be frozen and stored to be utilized in the future for research studies. These samples will be labeled using a key code instead of the subject name, and no one using these samples for future research will know your name. 3. Touch Preparation from the subject genital lesion being taken by our clinical care providers. Our research personnel will collect relevant information from your electronic medical records. The samples collected in this study could be used for genetic research studies. However, these results will not be added to your medical records. The samples collected in this study could be used to develop new treatments, drugs, or for other commercial purposes/third party company

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Srinivasan Professor and Chair, MD

CONTACT

6018156868; svijayakumar@umc.edu

Mary R Nittala, DrPH

CONTACT

6019842562; mnittala@umc.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 13, 2022
• Study Start: January 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 13, 2022

Record last verified: 2022-09