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Blood and Urine HPVDNA as Minimally Invasive Biomarkers for Cervical Cancer Detection and Surveillance Following Treatment

Sponsor
UNC Lineberger Comprehensive Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04743674
Collaborator
(none)
30
Enrollment
1
Location
55.5
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if ctHPVDNA (circulating tumor HPV DNA) can be used as a non-invasive biomarker for identification and treatment monitoring of cervical cancer by characterizing correlation between plasma ctHPVDNA, urine transrenal HPVDNA (TrHPVDNA) levels and presence of cervical cancer at diagnosis and following definitive intent management.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Early stage cervical cancer is managed surgically while chemoradiation is the mainstay for treatment of bulky or advanced stage disease. The primary aim of post-treatment surveillance is to detect early recurrences and guide additional therapy. There is no definitive agreement on the best practice for cervical cancer surveillance. Most recurrences are detected based on patient history and physical exam as there is limited data to support cervicovaginal cytology and routine use of imaging in follow up. Novel non-invasive biomarkers are needed to monitor disease status, detect early recurrence and guide personalized treatment decisions. Biospecimens including urine and blood plasma will be collected from patients presenting to the UNC Department of Gynecology Oncology and Multidisciplinary clinics with newly diagnosed cervical cancer to assess for HPVDNA. Archived or residual tissue will also be accessed. For patients who undergo definitive management with surgery or chemoradiation, a post-treatment blood plasma and urine sample will be collected 2-6 weeks after completion and will be compared to pre-therapy ctHPVDNA and TrHPVDNA levels.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    LCCC 2051:Plasma Circulating Tumor HPVDNA and Transrenal HPVDNA as Minimally Invasive Biomarkers for Cervical Cancer Detection and Surveillance Following Definitive Treatment
    Anticipated Study Start Date :
    Sep 15, 2022
    Anticipated Primary Completion Date :
    May 1, 2024
    Anticipated Study Completion Date :
    May 1, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Relationship between ctHPVDNA levels in plasma, TrHPVDNA levels in urine, and presence of cervical cancer in women being evaluated in clinic. [Baseline]

      We will quantify ctHPVDNA levels in blood plasma and TrHPVDNA in urine from patients with cervical cancer at time of diagnosis.

    Secondary Outcome Measures

    1. Change in ctHPVDNA and TrHPVDNA levels following definitive intent therapy for early stage disease. [2-6 weeks post-treatment]

      We will collect bio-specimens and quantify ctHPVDNA and TrHPVDNA levels in plasma and urine, respectively, during their post-treatment visit typically 2-6 weeks post-surgery or last day of treatment visit (chemoradiation).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 years of age or older on day of signing informed consent

    • New diagnosis of cervical cancer

    • Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee

    Exclusion Criteria:
    • Women who are pregnant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Olivia Roberts Chapel Hill North Carolina United States 27599

    Sponsors and Collaborators

    • UNC Lineberger Comprehensive Cancer Center

    Investigators

    • Principal Investigator: Ashley Weiner, MD, UNC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    UNC Lineberger Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04743674
    Other Study ID Numbers:
    • LCCC 2051
    First Posted:
    Feb 8, 2021
    Last Update Posted:
    Feb 25, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms

    Study Results

    No Results Posted as of Feb 25, 2022