Cervical CancerNCT04857528
Detecting HPV DNA in Anal and Cervical Cancers
An observational study of Cervical Cancer and Anal Cancer, run by University of Chicago at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Cancer, Anal Cancer, HPV-Related Anal Squamous Cell Carcinoma
- What is being tested?
- Radiation Treatment With or Without Chemotherapy, Blood Sample Collection and HPV Genotyping (HPV DNA Test)
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Oct 2020to 15 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60612
Meredith Russell, mrussel3@uic.edu
Christina Son
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Clinical Trials Intake, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Christina Son, MD
About this study
Official title: 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.
- Conditions
- Cervical Cancer, Anal Cancer, HPV-Related Anal Squamous Cell Carcinoma, HPV-Related Cervical Carcinoma, HPV-Related Carcinoma, Uterine Cervical Cancer
- Being tested
- Radiation Treatment With or Without Chemotherapy, Blood Sample Collection, HPV Genotyping (HPV DNA Test), Testing Archival Tumor Tissue, Physical Exam
- Keywords
- HPV, radiation treatment, cervical cancer, anal cancer, uterine cervix
- Medical subject headings
- Uterine Cervical Neoplasms, Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation Treatment With or Without ChemotherapyRadiation
Standard care radiation treatment.
Blood Sample CollectionOther
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)Diagnostic test
A test used to detect the type of HPV DNA found in the participant's blood and tumor tissue samples.
Testing Archival Tumor TissueDiagnostic test
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 ExamOther
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)Diagnostic test
Tests that use computers and/or rotating x-rays to scan/create images of the body.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Participants With Detectable Circulating HPV DNA in Blood/Tumor Samples
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.
Measured: 25 months
Secondary outcomes (1)
Accuracy of HPV DNA Levels in Predicting Cancer Recurrence at 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start6 Oct 2020
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina Son, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857528
- Sponsor's protocol ID
- IRB20-0410
- Status last verified
- Mar 2026
- First submitted
- 8 Apr 2021
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating HPV DNA in Cancers of the Anus and Uterine Cervix Treated With Definitive Radiation Therapy
- ClinicalTrials.gov ID
- NCT04857528
- Acronym / sponsor ID
- IRB20-0410
- Conditions
- Cervical Cancer, Anal Cancer, HPV-Related Anal Squamous Cell Carcinoma, HPV-Related Cervical Carcinoma, HPV-Related Carcinoma, Uterine Cervical Cancer
- Keywords
- HPV, radiation treatment, cervical cancer, anal cancer, uterine cervix
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) | – | 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)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation Treatment With or Without ChemotherapyStandard care radiation treatment. | Radiation | Prospective (Participants Who Will Receive Radiation Treatment for HPV-Related Cancer During Study) |
| Blood Sample CollectionResearchers 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. | Other | Prospective (Participants Who Will Receive Radiation Treatment for HPV-Related Cancer During Study) |
| 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 | Prospective (Participants Who Will Receive Radiation Treatment for HPV-Related Cancer During Study) |
| Testing Archival Tumor TissueTumor 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. | Diagnostic test | Prospective (Participants Who Will Receive Radiation Treatment for HPV-Related Cancer During Study) |
| Physical ExamA 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). | Other | Prospective (Participants Who Will Receive Radiation Treatment for HPV-Related Cancer During Study) |
| 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. | Diagnostic test | Prospective (Participants Who Will Receive Radiation Treatment for HPV-Related Cancer During Study) |
Primary outcome
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.
1 secondary outcome
Accuracy of HPV DNA Levels in Predicting Cancer Recurrence at 24 Months
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina Son, MD principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Anal Cancer, run by University of Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Son, MD (773-702-6870, cson@radonc.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Participants With Detectable Circulating HPV DNA in Blood/Tumor Samples (time frame: 25 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.