Detecting HPV DNA in Anal and Cervical Cancers

Sponsor

University of Chicago (Other)

Overall Status

Recruiting

CT.gov ID

NCT04857528

Collaborator

(none)

Enrollment

Locations

37.3

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Anal Cancer HPV-Related Anal Squamous Cell Carcinoma HPV-Related Cervical Carcinoma HPV-Related Carcinoma Uterine Cervical Cancer	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 Diagnostic Test: Positron Emission Tomography Scan (PET Scan)/ Computed Tomography Scan (CT Scan)

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 6, 2020

Anticipated Primary Completion Date :

Nov 15, 2023

Anticipated Study Completion Date :

Nov 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Retrospective (Participants Who Have Already Been Treated for HPV-Related Cancer Before Study) 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) 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.	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. Diagnostic Test: 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.

Arm

Intervention/Treatment

Retrospective (Participants Who Have Already Been Treated for HPV-Related Cancer Before Study)

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)

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.

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.

Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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