Cervical CancerHPV-RICCONCT04683549
HPV Serum Level and FDG PET CT in Patients With Cervical Cancer Treated With Radical Radiochemotherapy
A study testing HPV serum level and FDG PET CT in patients with cervical cancer treated with radical radiochemotherapy in people with Cervical Cancer, run by The Greater Poland Cancer Centre at 1 site in Poland.
Trial summary
The main purpose of the study is to describe changes in plasma HPV DNA levels in patients with locally advanced cervical cancer during radical radiochemotherapy (CRT) and to correlate changes with response to treatment. Monitoring of the response to treatment will also be assessed in FDG PET CT imaging. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- HPV serum level and FDG PET CT in patients with cervical cancer treated with radical radiochemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 15 Jun 2020to 30 Jun 2024
- 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 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age Limits: more than 18Y Histologically confirmed squamous cell carcinoma, FIGO stage IB-IVA planned for radical radiochemotherapy Eastern Cooperative Oncology Group (ECOG) performance status 0,1,2
Who cannot join
- 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 Contraindication to radiochemotherapy Known pregnancy or lactating
Trial locations and contacts
1 site in 1 country.
Poland1 site
Greater Poland Cancer Centre / Oncological Gynecology Clinic
Poznan, Greater Poland Voivodeship, 61-866
About this study
Official title: HPV Serum Level and FDG PET CT in Patients With Cervical Cancer Treated With Radical Radiochemotherapy (HPV-RICCO - HPV Relation in Cervical Cancer Outcomes)
The main purpose of the study is to describe changes in plasma HPV DNA levels in patients with locally advanced cervical cancer during radical radiochemotherapy (CRT) and to correlate changes with response to treatment. Monitoring of the response to treatment will also be assessed in FDG PET CT imaging.
Read the detailed description
Ninety-five per cent of cervical cancer cases are caused by persistent infections with carcinogenic HPVs. Locally advanced stage IB2 to IVA cervical cancers are treated with definitive chemoradiation therapy (CRT). Despite known clinical prognostic factors of poor treatment outcome such as advanced stage and positive nodal status, we still don't know predictors of relapse.
HPV status will be assessed in the neoplastic tissue and DNA from the blood serum of patients with cervical cancer will be isolated and analyzed by real-time PCR. Plasma HPV DNA would identify patients with residual disease after CRT due to persistent detectable HPV. This would earlier detect high risk patients who would benefit from adjuvant therapy.
While metabolic response in post - therapy FDG PET CT is predictive of survival, there is usually 3 months waiting period time needed to perform this imaging. This pilot study will provide preliminary estimates of the correlation between plasma HPV DNA level, PET finding and clinical outcome in polish cervical cancer patients.
- Conditions
- Cervical Cancer
- Being tested
- HPV serum level and FDG PET CT in patients with cervical cancer treated with radical radiochemotherapy
- Keywords
- locally advanced cervical cancer, HPV, radiochemotherapy, FDG PET CT
- 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.
HPV serum level and FDG PET CT in patients with cervical cancer treated with radical radiochemotherapyDiagnostic test
Locally advanced non-operable newly diagnosed FIGO stage IB-IVA cervical cancer patients planned for definitive radiochemotherapy will be accrued to study and will have:
- FDG PET Scan before treatment and 3 months after treatment
- Pre- treatment DNA from the neoplastic time preserved in the form of paraffin blocks to determine HPV status
- Blood sample to measure HPV DNA at time point baseline (before treatment), in the middle of treatment and at the end of definitive radiochemotherapy,
- [F-18] - FDG PET scan before treatment and 3 months post completion of radiochemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| One-Arm HPV serum level and FDG PET CT | Other | HPV serum level and FDG PET CT in patients with cervical cancer treated with radical radiochemotherapy Receives: Diagnostic Test: HPV serum level and FDG PET CT in patients with cervical cancer treated with radical radiochemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
local control
Measured: 18 months
Response to treatment
Measured: 6 months
Secondary outcomes (2)
Progression-free survival
Measured: 18 months
Plasma HPV DNA levels
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 posted24 Dec 2020
- Study start15 Jun 2020
- Primary completion31 May 2022
- Study completion30 Jun 2024 (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.
- 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
- Locally advanced non-operable newly diagnosed FIGO stage IB-IVA cervical cancer patients planned for definitive radiochemotherapy will be accrued to study and will have: 1. FDG PET Scan before treatment and 3 months after treatment 2. Pre- treatment DNA from the neoplastic time preserved in the form of paraffin blocks to determine HPV status 3. Blood sample to measure HPV DNA at time point baseline (before treatment), in the middle of treatment and at the end of definitive radiochemotherapy, 4. \[F-18\] - FDG PET scan before treatment and 3 months post completion of radiochemotherapy.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Greater Poland Cancer Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ewa Burchardt, PhD, MD, Principal investigator, Oncological Gynecology Clinic / GPCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683549
- Sponsor's protocol ID
- 15/06/2020/E/WCO/007
- Acronym
- HPV-RICCO
- Status last verified
- Dec 2023
- First submitted
- 21 Dec 2020
- Last updated
- 8 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV Serum Level and FDG PET CT in Patients With Cervical Cancer Treated With Radical Radiochemotherapy (HPV-RICCO - HPV Relation in Cervical Cancer Outcomes)
- ClinicalTrials.gov ID
- NCT04683549
- Acronym / sponsor ID
- HPV-RICCO / 15/06/2020/E/WCO/007
- Conditions
- Cervical Cancer
- Keywords
- locally advanced cervical cancer, HPV, radiochemotherapy, FDG PET CT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Greater Poland Cancer CentreUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 24 Dec 2020 (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.
The main purpose of the study is to describe changes in plasma HPV DNA levels in patients with locally advanced cervical cancer during radical radiochemotherapy (CRT) and to correlate changes with response to treatment. Monitoring of the response to treatment will also be assessed in FDG PET CT imaging.
Detailed description
Ninety-five per cent of cervical cancer cases are caused by persistent infections with carcinogenic HPVs. Locally advanced stage IB2 to IVA cervical cancers are treated with definitive chemoradiation therapy (CRT). Despite known clinical prognostic factors of poor treatment outcome such as advanced stage and positive nodal status, we still don't know predictors of relapse.
HPV status will be assessed in the neoplastic tissue and DNA from the blood serum of patients with cervical cancer will be isolated and analyzed by real-time PCR. Plasma HPV DNA would identify patients with residual disease after CRT due to persistent detectable HPV. This would earlier detect high risk patients who would benefit from adjuvant therapy.
While metabolic response in post - therapy FDG PET CT is predictive of survival, there is usually 3 months waiting period time needed to perform this imaging. This pilot study will provide preliminary estimates of the correlation between plasma HPV DNA level, PET finding and clinical outcome in polish cervical cancer patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Locally advanced non-operable newly diagnosed FIGO stage IB-IVA cervical cancer patients planned for definitive radiochemotherapy will be accrued to study and will have: 1. FDG PET Scan before treatment and 3 months after treatment 2. Pre- treatment DNA from the neoplastic time preserved in the form of paraffin blocks to determine HPV status 3. Blood sample to measure HPV DNA at time point baseline (before treatment), in the middle of treatment and at the end of definitive radiochemotherapy, 4. [F-18] - FDG PET scan before treatment and 3 months post completion of radiochemotherapy.
| Arm | Type | Receives |
|---|---|---|
| One-Arm HPV serum level and FDG PET CT | Other | Diagnostic Test: HPV serum level and FDG PET CT in patients with cervical cancer treated with radical radiochemotherapyHPV serum level and FDG PET CT in patients with cervical cancer treated with radical radiochemotherapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age Limits: more than 18Y Histologically confirmed squamous cell carcinoma, FIGO stage IB-IVA planned for radical radiochemotherapy Eastern Cooperative Oncology Group (ECOG) performance status 0,1,2
Key exclusion criteria (1 listed)
- 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 Contraindication to radiochemotherapy Known pregnancy or lactating
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 |
|---|---|---|
| HPV serum level and FDG PET CT in patients with cervical cancer treated with radical radiochemotherapyLocally advanced non-operable newly diagnosed FIGO stage IB-IVA cervical cancer patients planned for definitive radiochemotherapy will be accrued to study and will have: 1. FDG PET Scan before treatment and 3 months after treatment 2. Pre- treatment DNA from the neoplastic time preserved in the form of paraffin blocks to determine HPV status 3. Blood sample to measure HPV DNA at time point baseline (before treatment), in the middle of treatment and at the end of definitive radiochemotherapy, 4. [F-18] - FDG PET scan before treatment and 3 months post completion of radiochemotherapy. | Diagnostic test | One-Arm HPV serum level and FDG PET CT |
Primary outcome
local control
Time frame: 18 months
Response to treatment
Time frame: 6 months
2 secondary outcomes
Progression-free survival
Time frame: 18 months
Plasma HPV DNA levels
Time frame: Up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
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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.
Ewa Burchardt, PhD, MD principal investigator
Oncological Gynecology Clinic / GPCC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV serum level and FDG PET CT in patients with cervical cancer treated with radical radiochemotherapy in people with Cervical Cancer, run by The Greater Poland Cancer Centre at 1 site in Poland.
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 1 inclusion and 1 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 8 Jan 2024. 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 Poland. 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?
local control (time frame: 18 months). The study lists 2 primary outcomes in all. 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 8 Jan 2024.