Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
20 participants
OBSERVATIONAL
2020-10-06
2027-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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).
No interventions assigned to this group
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 Treatment With or Without Chemotherapy
Standard care radiation treatment.
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.
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.
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).
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.
Interventions
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Radiation Treatment With or Without Chemotherapy
Standard care radiation treatment.
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.
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.
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).
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.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Planned to undergo radiation therapy as definitive treatment, with or without concurrent systemic therapy
Exclusion Criteria
* Planned to undergo radiation therapy as an adjuvant or post-operative therapy
18 Years
ALL
No
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Christina Son, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Illinois at Chicago
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Countries
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Other Identifiers
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IRB20-0410
Identifier Type: -
Identifier Source: org_study_id
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