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Plasma Circulating Tumor HPVDNA and Transrenal HPVDNA as Minimally Invasive Biomarkers for Cervical Cancer Detection and Surveillance following Definitive Treatment
Trial Status: active
This study is being done to determine if a DNA test can effectively determine the relationship between blood plasma circulating tumor human papilloma virus DNA (ctHPVDNA) levels, urine transrenal HPVDNA (TrHPVDNA) levels and presence of cervical cancer in women and to assess the change in ctHPVDNA and TrHPVDNA levels following treatment of cancer. If this can be determined, the hope is to use this test in the future for screening purposes in low resource settings and for early cervical cancer recurrence detection.
Inclusion Criteria
* Ability and willingness of participant to provide written informed consent
* Participant is at least 18 years of age on day of signing informed consent
* Participant has a new diagnosis of cervical cancer
Exclusion Criteria
* The participant is pregnant
* The participant has other illnesses that would limit compliance with study requirements or has a problem that would make participation in the study unsafe, or complicate interpretation of study findings based on the judgement of the investigator or designee
Additional locations may be listed on ClinicalTrials.gov for NCT04743674.
I. To establish the relationship between ctHPVDNA levels in plasma and TrHPVDNA levels in urine and presence of cervical cancer in women being evaluated for cervical cancer in the UNC Gynecology Oncology, UNC Radiation Oncology and Multidisciplinary clinics at Chapel Hill, USA and Kamuzu Central Hospital, Malawi.
OUTLINE: This is an observational study.
Patients undergo collection of blood and urine samples and have their medical records reviewed on study. Patients may also undergo collection of tissue samples on study. Additionally, patients may undergo standard of care chemoradiation or surgery on study.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
