Detecting HPV DNA in Anal and Cervical Cancers

Suspended

• Conditions: Uterine Cervical Cancer; HPV-Related Anal Squamous Cell Carcinoma; HPV-Related Carcinoma; HPV-Related Cervical Carcinoma; Cervical Cancer; Anal Cancer

• 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

Study Timeline

• Study Start: 2020-10-06
• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-23
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-06
• Last Update Posted: 2025-06-08
• Primary Completion: 2027-11-15
• Study Completion: 2027-11-15

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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