Clinical trial · Observational
Detecting HPV DNA in Anal and Cervical Cancers
Circulating HPV DNA in Cancers of the Anus and Uterine Cervix Treated With Definitive Radiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| HPV-Related Anal Squamous Cell Carcinoma | Human Papillomavirus-Related Anal Squamous Cell Carcinoma | ALIAS | 0.90 |
| HPV-Related Carcinoma | Human Papillomavirus-Related Carcinoma | ALIAS | 0.90 |
| HPV-Related Cervical Carcinoma | Human Papillomavirus-Related Cervical Carcinoma | ALIAS | 0.90 |
| Uterine Cervical Cancer | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Sample Collection | Other | — | UNRESOLVED |
| HPV Genotyping (HPV DNA Test) | Diagnostic Test | — | UNRESOLVED |
| Physical Exam | Other | — | UNRESOLVED |
| Positron Emission Tomography Scan (PET Scan)/ Computed Tomography Scan (CT Scan) | Diagnostic Test | — | UNRESOLVED |
| Radiation Treatment With or Without Chemotherapy | Radiation | — | UNRESOLVED |
| Testing Archival Tumor Tissue | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Retrospective (Participants Who Have Already Been Treated for HPV-Related Cancer Before Study)
- description
- This group will use medical records from participants who have already received chemoradiation for their HPV-related anal or cervical cancer at a time before this study started. Because they have already received treatment, these participants will provide previous blood/tumor tissue samples that contain detectable HPV DNA as well as at least one post-treatment sample that their doctor collected before the study. Data from these previously collected samples will be compared to current samples from participants who are actively enrolled in this study in present day (chart review).
- label
- Prospective (Participants Who Will Receive Radiation Treatment for HPV-Related Cancer During Study)
- description
- 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.
- interventionNames
- Radiation: Radiation Treatment With or Without Chemotherapy
- Other: Blood Sample Collection
- Diagnostic Test: HPV Genotyping (HPV DNA Test)
- Diagnostic Test: Testing Archival Tumor Tissue
- Other: Physical Exam
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available