Cervical Cancer, Anal Cancer, HPV-Related Anal Squamous Cell Carcinoma, HPV-Related Cervical Carcinoma, HPV-Related Carcinoma, Uterine Cervical Cancer
Conditions
Keywords
HPV, radiation treatment, cervical cancer, anal cancer, uterine cervix
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.
Interventions
RADIATIONRadiation Treatment With or Without Chemotherapy
Standard care radiation treatment.
OTHERBlood 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_TESTHPV Genotyping (HPV DNA Test)
A test used to detect the type of HPV DNA found in the participant's blood and tumor tissue samples.
DIAGNOSTIC_TESTTesting 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.
OTHERPhysical 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_TESTPositron 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.
Sponsors
University of Chicago
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTChristina Son, MD
PRINCIPAL_INVESTIGATORChristina Son, MD
University of Chicago
Outcome results
None listed