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

NCT04743674 | Recruiting DMC

• 1 other identifier: LCCC 2051
• Study Type: observational
• Target: 30
• Locations: 2 countries
• Sites: 2

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Relationship between ctHPVDNA levels in plasma, TrHPVDNA levels in urine, and presence of cervical cancer in women being evaluated in clinic.

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

  Baseline

Secondary Outcomes (1)

• Change in ctHPVDNA and TrHPVDNA levels following definitive intent therapy for early stage disease.

  2-6 weeks post-treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with newly diagnosed cervical cancer planning to be treated with surgery or chemoradiation.

You may qualify if:

• 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

You may not qualify if:

• Women who are pregnant

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (2)

Melissa Knutsen

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Kamuzu Central Hospital

Lilongwe, Malawi

NOT YET RECRUITING

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, and archived/ left over biopsy tissue will be tested for HPVDNA and retained for up to 15 years.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Shivani Sud, MD

  UNC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa E Knutsen

CONTACT

919-445-4869; melissa_knutsen@med.unc.edu

Study Design

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

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: May 3, 2024
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

US (1); MA (1)