RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Plasma Circulating Tumor HPVDNA and Transrenal HPVDNA as Minimally Invasive Biomarkers for Cervical Cancer Detection and Surveillance Following Definitive Treatment

Quick Facts

Study Start:2024-05-03
Study Completion:2027-01-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04743674

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older on day of signing informed consent
  2. * New diagnosis of cervical cancer
  3. * Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee
  1. * Women who are pregnant

Contacts and Locations

Study Contact

Melissa E Knutsen
CONTACT
919-445-4869
melissa_knutsen@med.unc.edu

Principal Investigator

Shivani Sud, MD
PRINCIPAL_INVESTIGATOR
UNC

Study Locations (Sites)

Melissa Knutsen
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

  • Shivani Sud, MD, PRINCIPAL_INVESTIGATOR, UNC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-03
Study Completion Date2027-01-15

Study Record Updates

Study Start Date2024-05-03
Study Completion Date2027-01-15

Terms related to this study

Additional Relevant MeSH Terms

  • Cervical Cancer