Recruiting

Biomarkers

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT04743674

Conditions

Cervical Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT04743674

Start date

May 3, 2024

Status verified date

May, 2026

Completion date

Jan 15, 2027

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Melissa E Knutsen

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

Locations

Melissa Knutsen

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Melissa Knutsen

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

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

May 12, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-05-12.