Clinical, Translational and Biomarker-Based Female Genital HPV Induced Dysplasia and Cancer Screening Study Using Cf-HPV-DNA Blood Tests (TTMV HPV DNA)
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|ClinicalTrials.gov Identifier: NCT05536843|
Recruitment Status : Not yet recruiting
First Posted : September 13, 2022
Last Update Posted : September 13, 2022
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|Condition or disease|
|Cervical Dysplasia, Uterine Vaginal Dysplasia Vulvar Dysplasia|
- The HPV induced dysplasia in cervical and vaginal tissues can lead to a detectable level of TTMV-HPV-DNA in the blood.
- Those levels will increase when there is progression of the dysplasia from lower grade to a higher grade.
- The blood levels of TTMV-HPV-DNA can distinguish lower versus higher grades of HPV induced dysplasia.
- Serial measurements of TTMV-HPV-DNA in the blood can help diagnose progression of dysplasia to a higher grade earlier and in a more efficient and convenient way. This will help improved compliance with screening, early diagnosis, early interventions, and better clinical outcomes.
- TTMV-HPV-DNA detection is also likely possible with touch preparations on the lesions, thus leading to easier diagnosis of such lesions.
- To collect blood and touch-preparation samples from the dysplasia lesions among patients with HPV induced dysplasia in cervical and vaginal tissues in human subjects with such lesions in a phase I/II clinical trial setting.
- Measure TTMV-HPV-DNA in those samples.
- 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.
- Design future studies from these findings to enable early detection of potential progression to malignancy so that early curative interventions can be instituted.
- To develop an innovative and pilot clinical trial in HPV related female genital dysplasia that integrates basic science, public health, clinical and translational cutting-edge knowledge and information using 'liquid biopsy' concepts to help prevent progression to malignancy.
- To collect and analyze data in a prospective manner among a diverse population in terms of ethnic, racial, and socioeconomic variations that could help improve screening acceptance in the most vulnerable women at risk for female genital cancer.
- To serve as a model for middle and low-income countries as well as resource-scarce, rural and disparity-affected populations in high-income countries in developing a blood-specimen based HPV-related early diagnosis screening tool.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Circulating Cell-Free Tumor Tissue Modified Viral (TTMV)-HPV DNA As A Biomarker For Early Cancer Detection Among Human Subjects With HPV-Induced Dysplasia In Female Genital [Uterine Cervix, Vaginal and Vulvar] Organs: A Clinical, Translational and Biomarker-Based Cancer Screening Study|
|Estimated Study Start Date :||January 2023|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
- CORRELATION BETWEEN BLOOD BASED 'LIQUID BIOPSY' BIOMARKER TO TISSUE DIAGNOSIS [ Time Frame: 1 year ]
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."
Biospecimen Retention: Samples With DNA
- Blood collection from the subject vein by UMMC's trained professionals of about four table spoons of blood like for any other blood test.
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 100 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||Adult women with female genital dysplasia; Non pregnant women; No prisoners; Competent to give informed consent|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- Adult women with female genital dysplasia
- Non pregnant women
- No prisoners
- age in between 18 years and 100 years
- Competent to give informed consent
- Pregnant women
- Female below 18 years
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05536843
|Contact: Srinivasan Professor and Chair, MDfirstname.lastname@example.org|
|Contact: Mary R Nittala, DrPHemail@example.com|
|Responsible Party:||University of Mississippi Medical Center|
|Other Study ID Numbers:||
|First Posted:||September 13, 2022 Key Record Dates|
|Last Update Posted:||September 13, 2022|
|Last Verified:||September 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Female Genital Cancer
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Uterine Cervical Diseases
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type