Cervical CancerNCT02388698
FDG-PET and Circulating HPV in Patients With Cervical Cancer
A study testing Cervical swab, PET-CT and Plasma HPV in people with Cervical Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
The addition of concurrent chemotherapy to definitive radiation has improved the 5-year survival of women with locally advanced cervical cancer to 58%. To determine if plasma HPV DNA predates clinical recurrence and/or improves the accuracy of metabolic response on FDG-PET at 3 months post completion of radical… 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?
- Cervical swab, PET-CT and Plasma HPV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteCanada
- Study dates
- 23 Nov 2016to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- planned for radical radiotherapy and concurrent cisplatin chemotherapy.
- Age ≥ 18 years.
- Life expectancy of greater than 3 months.
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.
- Eastern Cooperative Oncology Group (ECOG) performance status > 2
- Other cervical cancer tumor histologies (e.g. small cell, serous)
- Contraindications to 18FDG PET-CT
- Inability to lie supine for radiation and/or 18FDG PET-CT
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- 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.
About this study
Official title: FDG-PET and Circulating HPV in Patients With Cervical Cancer Treated With Definitive Chemoradiation
The addition of concurrent chemotherapy to definitive radiation has improved the 5-year survival of women with locally advanced cervical cancer to 58%. To determine if plasma HPV DNA predates clinical recurrence and/or improves the accuracy of metabolic response on FDG-PET at 3 months post completion of radical chemo-radiation in patients with locally advanced cervical cancer. Post therapy FDG-PET can help predict progression free survival and overall survival. In addition plasma HPV can be used to monitor response and detect early recurrence. Prospective study will recruit 20 patients with locally advanced cervical cancer to determine if plasma HPV DNA predates clinical recurrence and/or improves the accuracy response on post-therapy FDG-PET scan at 3 months.
Read the detailed description
The addition of concurrent chemotherapy to definitive radiation has improved the 5-year survival of women with locally advanced cervical cancer to 58%, there is much room for improvement. Post-therapy FDG-PET at 3 months can help predict progression-free and overall survival. Tumors continually shed their DNA into the circulation, where it can be accessed to measure disease burden. Cervical cancer is caused by Human Papilloma Virus (HPV); plasma HPV DNA could be used to monitor response and detect recurrence early. While plasma HPV DNA has been shown to correlate with prognosis and predict recurrence in other cancers, there is limited data in locally advanced cervical cancer.
This prospective multi-institutional study will recruit 20 patients with locally advanced cervical cancer to determine if plasma HPV DNA predates clinical recurrence and/or improves the accuracy response on post-therapy FDG-PET scan at 3 months. Patients will undergo phlebotomy at the following time-points for the measurement of circulating HPV DNA levels: a) baseline; b) end of radiotherapy;c) 3 months post completion of chemoradiation, along with 3-month FDG-PET and d) at recurrence. This study will provide preliminary estimates of the correlation between plasma HPV DNA level, PET finding and clinical outcome, and inform sample size calculation for a larger study. If proven useful in the future, plasma HPV DNA could enable the identification of patients at high risk of recurrence and individualized treatment.
- Conditions
- Cervical Cancer
- Being tested
- Cervical swab, PET-CT, Plasma HPV
- Keywords
- HPV DNA, PET-CT, Recurrent cervical cancer, chemoradiation
- 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.
Cervical swabProcedure or surgery
Cervical Swab at baseline.
HPV testing at recurrence, if applicable.
PET-CTRadiation
PET-CT will be completed 3 month post chemoradiation.
Plasma HPVBiological
Plasma HPV will be drawn at baseline, post radiation, 3 month post chemoradiation and at progression (if necessary).
| Study group | Role | What they receive |
|---|---|---|
| Cervical Swab, PET-CT and plasma HPV | Experimental | Participants will have a cervical swab, and plasma HPV at baseline. In addition, a plasma HPV test drawn after completion of radiation. 3 months post chemoradiation, patients will have a PET-CT and plasma HPV completed. Plasma HPV will be drawn at progression/recurrence, if applicable. Receives: Procedure: Cervical swab; Radiation: PET-CT; Biological: Plasma HPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in plasma HPV DNA to 3 months.
To determine if HPV DNA predates clinical recurrence and/or improves the accuracy of metabolic response on FDG-PET scan at 3 months post completion of radical chemoradiation in patients with locally advanced cervical cancer
Measured: Pre treatment and within the first 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study start23 Nov 2016
- Primary completionDec 2019
- Study completionDec 2023 (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 Sunnybrook Health Sciences CentreThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Responsible party
- Principal investigator, Dr. Eric Leung, Sunnybrook Health Sciences Centre
- Investigators
- Eric Leung, MD, Principal investigator, Sunnybrook Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388698
- Sponsor's protocol ID
- HPVDNA01
- Status last verified
- Sep 2021
- First submitted
- 24 Feb 2015
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. 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
- ClinicalTrials.gov ID
- NCT02388698
- Acronym / sponsor ID
- HPVDNA01
- Conditions
- Cervical Cancer
- Keywords
- HPV DNA, PET-CT, Recurrent cervical cancer, chemoradiation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- 23 Nov 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Mar 2015 (estimated)
- 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.
The addition of concurrent chemotherapy to definitive radiation has improved the 5-year survival of women with locally advanced cervical cancer to 58%. To determine if plasma HPV DNA predates clinical recurrence and/or improves the accuracy of metabolic response on FDG-PET at 3 months post completion of radical chemo-radiation in patients with locally advanced cervical cancer. Post therapy FDG-PET can help predict progression free survival and overall survival. In addition plasma HPV can be used to monitor response and detect early recurrence. Prospective study will recruit 20 patients with locally advanced cervical cancer to determine if plasma HPV DNA predates clinical recurrence and/or improves the accuracy response on post-therapy FDG-PET scan at 3 months.
Detailed description
The addition of concurrent chemotherapy to definitive radiation has improved the 5-year survival of women with locally advanced cervical cancer to 58%, there is much room for improvement. Post-therapy FDG-PET at 3 months can help predict progression-free and overall survival. Tumors continually shed their DNA into the circulation, where it can be accessed to measure disease burden. Cervical cancer is caused by Human Papilloma Virus (HPV); plasma HPV DNA could be used to monitor response and detect recurrence early. While plasma HPV DNA has been shown to correlate with prognosis and predict recurrence in other cancers, there is limited data in locally advanced cervical cancer.
This prospective multi-institutional study will recruit 20 patients with locally advanced cervical cancer to determine if plasma HPV DNA predates clinical recurrence and/or improves the accuracy response on post-therapy FDG-PET scan at 3 months. Patients will undergo phlebotomy at the following time-points for the measurement of circulating HPV DNA levels: a) baseline; b) end of radiotherapy;c) 3 months post completion of chemoradiation, along with 3-month FDG-PET and d) at recurrence. This study will provide preliminary estimates of the correlation between plasma HPV DNA level, PET finding and clinical outcome, and inform sample size calculation for a larger study. If proven useful in the future, plasma HPV DNA could enable the identification of patients at high risk of recurrence and individualized treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical Swab, PET-CT and plasma HPV | Experimental | Procedure: Cervical swab, Radiation: PET-CT, Biological: Plasma HPVParticipants will have a cervical swab, and plasma HPV at baseline. In addition, a plasma HPV test drawn after completion of radiation. 3 months post chemoradiation, patients will have a PET-CT and plasma HPV completed. Plasma HPV will be drawn at progression/recurrence, if applicable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix, FIGO stage IB-IVA
- planned for radical radiotherapy and concurrent cisplatin chemotherapy.
- Age ≥ 18 years.
- Life expectancy of greater than 3 months.
Key exclusion criteria (10 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.
- Eastern Cooperative Oncology Group (ECOG) performance status > 2
- Other cervical cancer tumor histologies (e.g. small cell, serous)
- Contraindications to 18FDG PET-CT
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 |
|---|---|---|
| Cervical swabCervical Swab at baseline. HPV testing at recurrence, if applicable. | Procedure or surgery | Cervical Swab, PET-CT and plasma HPV |
| PET-CTPET-CT will be completed 3 month post chemoradiation. | Radiation | Cervical Swab, PET-CT and plasma HPV |
| Plasma HPVPlasma HPV will be drawn at baseline, post radiation, 3 month post chemoradiation and at progression (if necessary). | Biological | Cervical Swab, PET-CT and plasma HPV |
Primary outcome
Change from baseline in plasma HPV DNA to 3 months.
Time frame: Pre treatment and within the first 3 months post treatment
To determine if HPV DNA predates clinical recurrence and/or improves the accuracy of metabolic response on FDG-PET scan at 3 months post completion of radical chemoradiation in patients with locally advanced cervical cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
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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. This study is not recruiting at the moment.
Eric Leung, MD principal investigator
Sunnybrook Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical swab, PET-CT and Plasma HPV in people with Cervical Cancer, run by Sunnybrook Health Sciences Centre 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 22 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in plasma HPV DNA to 3 months. (time frame: Pre treatment and within the first 3 months post treatment). 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 22 Sep 2021.