Cervical CancerHPVDNA02NCT03853915
FDG-PET and Circulating HPV in Patients With Cervical Cancer Treated With Definitive Chemoradiation (II)
A study testing [18-F]- FDG - PET in people with Cervical Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Nearly all cervical cancers are caused by the human papilloma virus (HPV), which can be detected in cancer tissue by laboratory tests. There is evidence that the virus can also be detected from a blood sample to monitor the effects of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- [18-F]- FDG - PET
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 23 Apr 2019to 30 Dec 2027
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix, FIGO stage IB-IVA
- 3.1.2 Planned for radical radiotherapy and concurrent cisplatin chemotherapy.
- 3.1.3 Age ≥ 18 years.
Who cannot join
- Evidence of distant metastases (suspicious paraaortic nodes below the renal vessels allowed if they will be encompassed within the radiation field)
- Patients who have received any anticancer treatment for their cervical cancer.
- Other cervical cancer tumor histologies (e.g. small cell, serous)
- Contraindications to 18FDG PET-CT
- Contraindication to radiotherapy (e.g. severe Crohn's disease)
- Contraindication to chemotherapy (e.g. non-reversible renal failure)
- History of another invasive malignancy, except for non-melanoma skin cancer or tumors curatively treated with no evidence of disease for ≥ 5 years.
- Known pregnancy or lactating
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network, The Princess Margaret
Toronto, Ontario, M5G 2M9
Kathy Han, MD, 416 946 4501 ext. 2919, Kathy.Han@rmp.uhn.on.ca
Michael Milosevic, MD, 416 946 4501 ext. 2932, Mike.Milosevic@rmp.uhn.on.ca
About this study
Nearly all cervical cancers are caused by the human papilloma virus (HPV), which can be detected in cancer tissue by laboratory tests. There is evidence that the virus can also be detected from a blood sample to monitor the effects of treatment. Previous studies have shown that a special test called 18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET-CT) at 3 months after treatment may predict survival in cervical cancer.
The purpose of this study is to see how well the FDG-PET Scan and blood tests for HPV can detect leftover cervical cancer cells after treatment. This study is not a particular form of treatment and patients will receive standard of care treatment.
Read the detailed description
Cervical cancer is the 4th most common malignancy in women worldwide. A significant proportion of women with locally advanced cervical cancer are primarily managed with chemotherapy and radiotherapy which has improved the 5-year survival and disease-free survival; however both local and distant recurrences still remain to be challenges after treatment.
A prospective study has shown that metabolic response on post-therapy FDG-PET scan at 3 months to be predictive of progression-free and overall survival in patients with locally advanced cervical cancer. It may also predict patterns of failures for these patients.
HPV is recognized as a necessary cause of the vast majority of cervical cancer and HPV DNA has been detected in circulation from patients with cervical cancer and oropharyngeal cancer at diagnosis and at the time of relapse. Despite the promising potential of HPV DNA to monitor response and detect recurrence at an early stage, no study has evaluated serial HPV DNA and its association with PET response and survival.
We have recently reported preliminary data from a feasibility study (HPVDNA01) on 20 patients. Detectable HPV DNA at the end of cervical radiation therapy predated the clinical diagnosis of metastases and was associated with inferior progression-free survival. Also, 3 month plasma HPV DNA level was more accurate than 3-month FDG PET imaging in detecting leftover disease. This follow-up study aims to validate the clinical utility of plasma HPV DNA detection.
- Conditions
- Cervical Cancer
- Being tested
- [18-F]- FDG - PET
- Keywords
- Cervical Cancer, PET Scan, HPV DNA
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18-F]- FDG - PETDiagnostic test
[F-18]-FDG Injection is an intravenous diagnostic radiopharmaceutical used for Positron Emission Tomography. While this is not the subject of investigation in this study, [F-18]-FDG will be used in the PET imaging assessment of study participants during their 3 month follow-up post-treatment.
| Study group | Role | What they receive |
|---|---|---|
| FDG PET Scan | Experimental | [F-18] - FDG PET Scan and blood sample to measure HPV DNA Receives: Diagnostic Test: [18-F]- FDG - PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival rate
The progression-free survival rate of patients with and without detectable plasma HPV DNA post treatment
Measured: up to 5 years
Secondary outcomes (1)
Plasma HPV DNA levels
The accuracy of 3-month FDG-PET or 3-month HPV DNA for predicting relapse will be estimated.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start23 Apr 2019
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Newly diagnosed FIGO stage IB-IVA cervical cancer patients planned for definitive chemoradiation will be accrued to study and will have: 1. FDG PET Scan at 3 month time point. 2. Blood sample to measure HPV DNA at time point baseline, end of radiotherapy, 4-6 weeks and 3 months post completion of definitive radiotherapy.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853915
- Sponsor's protocol ID
- 18-6277
- Acronym
- HPVDNA02
- Status last verified
- Mar 2026
- First submitted
- 22 Feb 2019
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han K, Zou J, Zhao Z, Baskurt Z, Zheng Y, Barnes E, Croke J, Ferguson SE, Fyles A, Gien L, Gladwish A, Lecavalier-Barsoum M, Lheureux S, Lukovic J, Mackay H, Marchand EL, Metser U, Milosevic M, Taggar AS, Bratman SV, Leung E. Clinical Validation of Human Papilloma Virus Circulating Tumor DNA for Early Detection of Residual Disease After Chemoradiation in Cervical Cancer. J Clin Oncol. 2024 Feb 1;42(4):431-440. doi: 10.1200/JCO.23.00954. Epub 2023 Nov 16.
PubMed 37972346
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FDG-PET and Circulating HPV in Patients With Cervical Cancer Treated With Definitive Chemoradiation (II)
- ClinicalTrials.gov ID
- NCT03853915
- Acronym / sponsor ID
- HPVDNA02 / 18-6277
- Conditions
- Cervical Cancer
- Keywords
- Cervical Cancer, PET Scan, HPV DNA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 26 Feb 2019 (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.
Nearly all cervical cancers are caused by the human papilloma virus (HPV), which can be detected in cancer tissue by laboratory tests. There is evidence that the virus can also be detected from a blood sample to monitor the effects of treatment. Previous studies have shown that a special test called 18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET-CT) at 3 months after treatment may predict survival in cervical cancer.
The purpose of this study is to see how well the FDG-PET Scan and blood tests for HPV can detect leftover cervical cancer cells after treatment. This study is not a particular form of treatment and patients will receive standard of care treatment.
Detailed description
Cervical cancer is the 4th most common malignancy in women worldwide. A significant proportion of women with locally advanced cervical cancer are primarily managed with chemotherapy and radiotherapy which has improved the 5-year survival and disease-free survival; however both local and distant recurrences still remain to be challenges after treatment.
A prospective study has shown that metabolic response on post-therapy FDG-PET scan at 3 months to be predictive of progression-free and overall survival in patients with locally advanced cervical cancer. It may also predict patterns of failures for these patients.
HPV is recognized as a necessary cause of the vast majority of cervical cancer and HPV DNA has been detected in circulation from patients with cervical cancer and oropharyngeal cancer at diagnosis and at the time of relapse. Despite the promising potential of HPV DNA to monitor response and detect recurrence at an early stage, no study has evaluated serial HPV DNA and its association with PET response and survival.
We have recently reported preliminary data from a feasibility study (HPVDNA01) on 20 patients. Detectable HPV DNA at the end of cervical radiation therapy predated the clinical diagnosis of metastases and was associated with inferior progression-free survival. Also, 3 month plasma HPV DNA level was more accurate than 3-month FDG PET imaging in detecting leftover disease. This follow-up study aims to validate the clinical utility of plasma HPV DNA detection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Newly diagnosed FIGO stage IB-IVA cervical cancer patients planned for definitive chemoradiation will be accrued to study and will have: 1. FDG PET Scan at 3 month time point. 2. Blood sample to measure HPV DNA at time point baseline, end of radiotherapy, 4-6 weeks and 3 months post completion of definitive radiotherapy.
| Arm | Type | Receives |
|---|---|---|
| FDG PET Scan | Experimental | Diagnostic Test: [18-F]- FDG - PET[F-18] - FDG PET Scan and blood sample to measure HPV DNA |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix, FIGO stage IB-IVA
- 3.1.2 Planned for radical radiotherapy and concurrent cisplatin chemotherapy.
- 3.1.3 Age ≥ 18 years.
Key exclusion criteria (8 listed)
- Evidence of distant metastases (suspicious paraaortic nodes below the renal vessels allowed if they will be encompassed within the radiation field)
- Patients who have received any anticancer treatment for their cervical cancer.
- Other cervical cancer tumor histologies (e.g. small cell, serous)
- Contraindications to 18FDG PET-CT
- Contraindication to radiotherapy (e.g. severe Crohn's disease)
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 |
|---|---|---|
| [18-F]- FDG - PET[F-18]-FDG Injection is an intravenous diagnostic radiopharmaceutical used for Positron Emission Tomography. While this is not the subject of investigation in this study, [F-18]-FDG will be used in the PET imaging assessment of study participants during their 3 month follow-up post-treatment. | Diagnostic test | FDG PET Scan |
Primary outcome
Progression-free survival rate
Time frame: up to 5 years
The progression-free survival rate of patients with and without detectable plasma HPV DNA post treatment
1 secondary outcome
Plasma HPV DNA levels
Time frame: Up to 3 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 5 Mar 2026.
- Derived from this study: PubMed 37972346Han K, Zou J, Zhao Z, Baskurt Z, Zheng Y, Barnes E, Croke J, Ferguson SE, Fyles A, Gien L, Gladwish A, Lecavalier-Barsoum M, Lheureux S, Lukovic J, Mackay H, Marchand EL, Metser U, Milosevic M, Taggar AS, Bratman SV, Leung E. Clinical Validation of Human Papilloma Virus Circulating Tumor DNA for Early Detection of Residual Disease After Chemoradiation in Cervical Cancer. J Clin Oncol. 2024 Feb 1;42(4):431-440. doi: 10.1200/JCO.23.00954. Epub 2023 Nov 16.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18-F]- FDG - PET in people with Cervical Cancer, run by University Health Network, Toronto at 1 site in Canada.
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 8 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 5 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 1 site in Canada. 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 Kathy Han, MD (416 946 4501 ext. 2919, kathy.han@rmp.uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival rate (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03853915, which also lists 1 linked publication.
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 5 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.