Detecting HPV DNA in Anal and Cervical Cancers
- Conditions
- Uterine Cervical CancerHPV-Related Anal Squamous Cell CarcinomaHPV-Related CarcinomaHPV-Related Cervical CarcinomaCervical CancerAnal Cancer
- Interventions
- Radiation: Radiation Treatment With or Without ChemotherapyOther: Blood Sample CollectionDiagnostic Test: HPV Genotyping (HPV DNA Test)Diagnostic Test: Testing Archival Tumor TissueOther: Physical ExamDiagnostic Test: Positron Emission Tomography Scan (PET Scan)/ Computed Tomography Scan (CT Scan)
- Registration Number
- NCT04857528
- Lead Sponsor
- University of Chicago
- Brief Summary
This is a research study for individuals who have cancer associated with human papillomavirus (HPV) and are being treated with radiation as part of standard care for their cancer. Doctors leading this study will use blood tests to find out if they can detect the HPV virus in the blood of study participants before, during, and after radiation treatment. They will also collect blood and archival tumor tissue (from a previous biopsy) to perform other tests in the future that could provide more information about HPV-associated cancers and how they respond to treatment. Participation in this study will last approximately 2 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 20
- Stage I-III anal cancer or stage I-IVA cervical cancer that is p16+ based on immunohistochemistry.
- Age ≥ 18 years
- Planned to undergo radiation therapy as definitive treatment, with or without concurrent systemic therapy
- Anal carcinoma not associated with HPV-16, 18, 31, 33, or 35 will be removed from the
- Planned to undergo radiation therapy as an adjuvant or post-operative therapy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prospective (Participants Who Will Receive Radiation Treatment for HPV-Related Cancer During Study) Radiation Treatment With or Without Chemotherapy This group is for participants who plan to receive radiation treatment (with or without chemotherapy) for their HPV-related anal or cervical cancer during the time this study will be conducted. Participants in this group will sign a consent form allowing researchers to collect their blood samples and analyze/compare them to the samples from the retrospective group of participants. Prospective (Participants Who Will Receive Radiation Treatment for HPV-Related Cancer During Study) Blood Sample Collection This group is for participants who plan to receive radiation treatment (with or without chemotherapy) for their HPV-related anal or cervical cancer during the time this study will be conducted. Participants in this group will sign a consent form allowing researchers to collect their blood samples and analyze/compare them to the samples from the retrospective group of participants. Prospective (Participants Who Will Receive Radiation Treatment for HPV-Related Cancer During Study) HPV Genotyping (HPV DNA Test) This group is for participants who plan to receive radiation treatment (with or without chemotherapy) for their HPV-related anal or cervical cancer during the time this study will be conducted. Participants in this group will sign a consent form allowing researchers to collect their blood samples and analyze/compare them to the samples from the retrospective group of participants. Prospective (Participants Who Will Receive Radiation Treatment for HPV-Related Cancer During Study) Testing Archival Tumor Tissue This group is for participants who plan to receive radiation treatment (with or without chemotherapy) for their HPV-related anal or cervical cancer during the time this study will be conducted. Participants in this group will sign a consent form allowing researchers to collect their blood samples and analyze/compare them to the samples from the retrospective group of participants. Prospective (Participants Who Will Receive Radiation Treatment for HPV-Related Cancer During Study) Positron Emission Tomography Scan (PET Scan)/ Computed Tomography Scan (CT Scan) This group is for participants who plan to receive radiation treatment (with or without chemotherapy) for their HPV-related anal or cervical cancer during the time this study will be conducted. Participants in this group will sign a consent form allowing researchers to collect their blood samples and analyze/compare them to the samples from the retrospective group of participants. Prospective (Participants Who Will Receive Radiation Treatment for HPV-Related Cancer During Study) Physical Exam This group is for participants who plan to receive radiation treatment (with or without chemotherapy) for their HPV-related anal or cervical cancer during the time this study will be conducted. Participants in this group will sign a consent form allowing researchers to collect their blood samples and analyze/compare them to the samples from the retrospective group of participants.
- Primary Outcome Measures
Name Time Method Rate of Participants With Detectable Circulating HPV DNA in Blood/Tumor Samples 25 months The rate of participants who have detectable HPV DNA in their blood and tumor samples as assessed by analyzing blood/ tumor tissue samples using Polymerase chain reaction (PCR) tests.
- Secondary Outcome Measures
Name Time Method Accuracy of HPV DNA Levels in Predicting Cancer Recurrence at 24 Months 24 months The accuracy of post-treatment HPV DNA levels in predicting cancer recurrence at 24 months after treatment. This accuracy will be assessed using statistical calculations incorporating data from the participant's HPV DNA detection test results and clinical records.
Trial Locations
- Locations (2)
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States