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Detecting HPV DNA in Anal and Cervical Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04857528
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : June 10, 2021
Information provided by (Responsible Party):
University of Chicago

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
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)

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Study Type : Observational
Estimated 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 : October 6, 2020
Estimated Primary Completion Date : November 15, 2023
Estimated Study Completion Date : November 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Group/Cohort 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.

Primary Outcome Measures :
  1. Rate of Participants With Detectable Circulating HPV DNA in Blood/Tumor Samples [ Time Frame: 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 :
  1. Accuracy of HPV DNA Levels in Predicting Cancer Recurrence at 24 Months [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be identified and selected from patients receiving treatment in the Departments of Radiation Oncology at University of Chicago and all participating sites where this study is being conducted including. Individuals from the public who have an HPV-associated cancer and fit the listed inclusion criteria can also be considered for participation in this study.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04857528

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Contact: Christina Son, MD 773-702-6870

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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Clinical Trials Intake    855-702-8222   
Principal Investigator: Christina Son, MD         
Sponsors and Collaborators
University of Chicago
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Principal Investigator: Christina Son, MD University of Chicago
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Responsible Party: University of Chicago Identifier: NCT04857528    
Other Study ID Numbers: IRB20-0410
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Chicago:
radiation treatment
cervical cancer
anal cancer
uterine cervix
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Anus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Anus Diseases
Uterine Cervical Diseases
Uterine Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases