- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04857528
Detecting HPV DNA in Anal and Cervical Cancers
January 26, 2024 updated by: University of Chicago
Circulating HPV DNA in Cancers of the Anus and Uterine Cervix Treated With Definitive Radiation Therapy
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
- 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 Type
Observational
Enrollment (Estimated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christina Son, MD
- Phone Number: 773-702-6870
- Email: cson@radonc.uchicago.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago
-
Principal Investigator:
- Christina Son, MD
-
Contact:
- Clinical Trials Intake
- Phone Number: 855-702-8222
- Email: cancerclinicaltrials@bsd.uchicago.edu
-
Chicago, Illinois, United States, 60612
- Recruiting
- University of Illinois at Chicago
-
Contact:
- Meredith Russell
- Email: mrussel3@uic.edu
-
Principal Investigator:
- Christina Son
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
Standard care radiation treatment.
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.
A test used to detect the type of HPV DNA found in the participant's blood and tumor tissue samples.
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.
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).
Tests that use computers and/or rotating x-rays to scan/create images of the body.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
25 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christina Son, MD, University of Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 6, 2020
Primary Completion (Estimated)
November 15, 2027
Study Completion (Estimated)
November 15, 2027
Study Registration Dates
First Submitted
April 8, 2021
First Submitted That Met QC Criteria
April 20, 2021
First Posted (Actual)
April 23, 2021
Study Record Updates
Last Update Posted (Actual)
January 29, 2024
Last Update Submitted That Met QC Criteria
January 26, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Anus Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
- Carcinoma
- Anus Neoplasms
Other Study ID Numbers
- IRB20-0410
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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