Detecting HPV DNA in Anal and Cervical Cancers

The University of Chicago

Status: Suspended

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

Treatments: Radiation: Radiation Treatment With or Without Chemotherapy; Diagnostic Test: Positron Emission Tomography Scan (PET Scan)/ Computed Tomography Scan (CT Scan); Other: Blood Sample Collection; Other: Physical Exam; Diagnostic Test: HPV Genotyping (HPV DNA Test); Diagnostic Test: Testing Archival Tumor Tissue

Study type: Observational

Funder types: Other

Identifiers

NCT04857528

IRB20-0410

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

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).

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.

Treatment:

Diagnostic Test: Testing Archival Tumor Tissue

Diagnostic Test: HPV Genotyping (HPV DNA Test)

Other: Physical Exam

Other: Blood Sample Collection

Diagnostic Test: Positron Emission Tomography Scan (PET Scan)/ Computed Tomography Scan (CT Scan)

Radiation: Radiation Treatment With or Without Chemotherapy