Clinical trial NCT04743674: Blood and Urine HPVDNA as Minimally Invasive Biomarkers for Cervical Cancer Detection and Surveillance Following Treatment
Official title: Plasma Circulating Tumor HPVDNA and Transrenal HPVDNA as Minimally Invasive Biomarkers for Cervical Cancer Detection and Surveillance Following Definitive Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with newly diagnosed cervical cancer planning to be treated with surgery or chemoradiation.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Relationship between ctHPVDNA levels in plasma, TrHPVDNA levels in urine, and presence of cervical cancer in women being evaluated in clinic.
timeFrame: Baseline
Secondary outcomes:
measure: Change in ctHPVDNA and TrHPVDNA levels following definitive intent therapy for early stage disease.
timeFrame: 2-6 weeks post-treatment
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Melissa Knutsen
state: North Carolina
city: Lilongwe
country: Malawi
facility: Kamuzu Central Hospital
Study officials:
affiliation: UNC
name: Shivani Sud, MD
role: PRINCIPAL_INVESTIGATOR
References: