Detecting HPV DNA in Anal and Cervical Cancers

Cervical Cancer Clinical Trial

Official title:

Circulating HPV DNA in Cancers of the Anus and Uterine Cervix Treated With Definitive Radiation Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04857528
• Other study ID #: IRB20-0410
• Status: Recruiting
• Start date: October 6, 2020
• Est. completion date: November 15, 2027

Study information

• Verified date: January 2024
• Source: University of Chicago
• Contact: Christina Son, MD
• Phone: 773-702-6870
• Email: cson[@]radonc.uchicago.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 15, 2027
• Est. primary completion date: November 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Carcinoma
• Cervical Cancer
• HPV-Related Anal Squamous Cell Carcinoma
• HPV-Related Carcinoma
• HPV-Related Cervical Carcinoma
• Uterine Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Radiation:
• Radiation Treatment With or Without Chemotherapy
Standard care radiation treatment.

Other:
• Blood Sample Collection
Researchers will collect blood samples from participants before, during and after radiation treatment. Approximately 6 teaspoons of blood will be collected each time blood is drawn.

Diagnostic Test:
• HPV Genotyping (HPV DNA Test)
A test used to detect the type of HPV DNA found in the participant's blood and tumor tissue samples.
• Testing Archival Tumor Tissue
Tumor tissue will be tested in a lab for all cervical cancer participants and some participants with anal cancer as assessed by the lead study doctor. This tumor tissue sample will be from a previous biopsy that the participant received before the study per standard care; no new biopsy will be required for this study.

Other:
• Physical Exam
A physical exam will be given 12 months after radiation treatment. This physical exam may also include an anoscopy (a procedure to examine the anus using a device inserted into the anus) or sigmoidoscopy (a procedure that looks at the rectum and lower part of the colon using a device inserted into the anus).

Diagnostic Test:
• Positron Emission Tomography Scan (PET Scan)/ Computed Tomography Scan (CT Scan)
Tests that use computers and/or rotating x-rays to scan/create images of the body.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Participants With Detectable Circulating HPV DNA in Blood/Tumor Samples	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.	25 months
Secondary	Accuracy of HPV DNA Levels in Predicting Cancer Recurrence at 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.	24 months