Cervical CancerNCT05774561
Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring
An observational study of Cervical Cancer and Cervical Dysplasia, run by The Institute of Molecular and Translational Medicine, Czech Republic at 1 site in Czechia.
Trial summary
This trial will evaluate the possible benefits and the performance of liquid biopsies in HPV-associated cancer treatment monitoring. This study aims to find a combination of an adequately sensitive and specific sampling method and biomarkers for early risk stratification of disease recurrence. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cervical Cancer, Cervical Dysplasia, Oropharyngeal Cancer
- What is being tested?
- Arm A - Diagnostic test: HPV detection in liquid biopsies and Arm B - Diagnostic test: HPV detection in liquid biopsies
- How many people
- 480 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2022to 1 Dec 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Oropharyngeal cancer patients, Cervical cancer patients
Who may be able to join
- Women diagnosed with CC/HSIL. Men and women diagnosed with OPC. Patients must agree with study enrollment and must sign study informed consent.
Who cannot join
- No exclusion criteria are set.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Olomouc
Olomouc, 77900
Marian Hajduch, MD, PhD., +420 585 632 083, marian.hajduch@upol.cz
Vladimira Koudelakova, MSc., PhD., +420 585 632 089, vladimira.koudelakova@upol.cz
About this study
Official title: Liquid Biopsies - a Possible Tool for Treatment Monitoring and Early Recurrence Detection in HPV-associated Diseases
This trial will evaluate the possible benefits and the performance of liquid biopsies in HPV-associated cancer treatment monitoring. This study aims to find a combination of an adequately sensitive and specific sampling method and biomarkers for early risk stratification of disease recurrence.
Read the detailed description
Although the cancers associated with human papillomavirus (HPV) infection are currently almost entirely preventable, a significant part of the Czech population suffers from these diseases. The most common HPV-associated cancers are cervical cancer (CC) and oropharyngeal cancer (OPC). In these, the severe problem is successful monitoring of the treatment effectiveness and early disease recurrence detection. It is, therefore, necessary to find a non-invasive method that could specifically and timely identify patients at risk of recurrence and thus enable patients with quality and less burdensome medical care. The use of liquid biopsies (LB), which the study focuses on, looks most promising.
This study is divided into two arms, with each arm including both prospective and retrospective parts. Into prospective parts will be enrolled only newly diagnosed CC/HSIL (high-grade cervical intraepithelial lesions) or OPC patients. In contrast, the retrospective part will enroll patients in post-treatment follow-up. In both study arms, fresh tumor tissues will be sampled from patients in prospective parts before treatment, and archived Formalin Fixed Paraffin Embedded (FFPE) tissue samples will be obtained from patients of retrospective parts.
Regarding the liquid biopsies, pre \& post-treatment sampling of LB will be performed. Subsequently, regular sample acquisition will be performed during follow-up according to the standard medical practice in both prospective and retrospective parts. Oropharyngeal swabs, gargle lavage,exhaled breath condensate (EBC), and blood samples will be collected from OPC patients. Blood collection and self-sampling of cervicovaginal swabs will be performed in patients with CC/HSIL. All samples, excluding blood samples, will be tested for the presence of the most prevalent high-risk and low-risk HPV genotypes. The circulating tumor (ct) HPV DNA will be monitored in blood samples. Additionally, the mutation profile of the primary tumors will be examined in fresh and FFPE samples.
The dynamics of HPV DNA will be monitored throughout all follow-up samples and correlated with the obtained clinical data. A created panel of frequently altered genes will be used for alterations monitoring in liquid biopsies. In the final analysis of laboratory and clinical results, we assume a finding of a clinically usable algorithm that could predict the risk of disease recurrence for a particular patient.
- Being tested
- Arm A - Diagnostic test: HPV detection in liquid biopsies, Arm B - Diagnostic test: HPV detection in liquid biopsies
- Keywords
- human papillomavirus, HPV, liquid biopsies, cervicovaginal swab, cervical cancer, oropharyngeal cancer
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia, Oropharyngeal Neoplasms, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm A - Diagnostic test: HPV detection in liquid biopsiesDiagnostic test
Patients will be asked to perform self-collection of gargle lavage samples. Oropharyngeal swabs, breath condensate, and blood samples will be taken by trained clinicians.
Arm B - Diagnostic test: HPV detection in liquid biopsiesDiagnostic test
Patients will be asked to perform cervicovaginal self-sampling using Evalyn Brush. Blood samples will be taken by trained clinicians.
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Oropharyngeal cancer patients | In total, approx. 200 OPC cancer patients will be enrolled in the study Arm A, with both prospective and retrospective parts enrolling 100 OPC patients. The Arm A will enroll patients from the Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Olomouc. Pre-treatment primary samples of fresh or FFPE tissue samples will be collected. Liquid biopsies (gargle lavage, oropharyngeal smear, breath condensate, and blood sample) will be collected. Obtained samples will be tested by CE-IVD (device complies with European in vitro diagnostic Directive) marked HPV diagnostic test. A laboratory developed digital droplet PCR assay will be used for ct HPV DNA detection. Sampling will be performed at pre \& post treatment check-ups, and every 3 months for 3 years and every 6 months for 2 years. Receives: Diagnostic Test: Arm A - Diagnostic test: HPV detection in liquid biopsies | |
| Arm B - Cervical cancer patients | Into the study Arm B will be enrolled 80 patients with CC and 120 patients with HSIL, and 80 patients will be enrolled into the retrospective part. The Arm B will enroll patients from the Department of Gynecology and Obstetrics, University Hospital Olomouc. Pre-treatment primary samples of fresh or FFPE tissue samples will be collected. Liquid biopsies (cervicovaginal swab and blood sample) will be collected. Obtained samples will be tested by CE-IVD marked HPV diagnostic test. A laboratory developed digital droplet PCR assay will be used for ct HPV DNA detection. Sampling will be performed at pre \& post treatment check-ups, and every 3 months for 2 years and every 6 months for 3 years. Receives: Diagnostic Test: Arm B - Diagnostic test: HPV detection in liquid biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamics of HPV infection in cervical cancer patients during 4-year follow-up.
HPV-status in liquid biopsies collected during pre-treatment, post-treatment and follow-up check-ups.
Measured: 4 years
Dynamics of HPV infection in oropharyngeal cancer patients during 4-year follow-up.
HPV-status in liquid biopsies collected during pre-treatment, post-treatment and follow-up check-ups.
Measured: 4 years
Dynamics of circulating tumor (ct) HPV DNA in oropharyngeal cancer patients.
Correlation of plasmatic ct HPV DNA level with cancer patient´s prognosis.
Measured: 4 years
Dynamics of circulating tumor (ct) HPV DNA in cervical cancer patients
Correlation of plasmatic ct HPV DNA level with patient´s prognosis
Measured: 4 years
Analysis of the mutational landscape of oropharyngeal cancer cases.
Correlation of tumor mutational burden (TMB) with cancer patient´s prognosis.
Measured: 4 years
Analysis of the mutational landscape of cervical cancer cases.
Correlation of tumor mutational burden (TMB) with cancer patient´s prognosis.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start1 Jun 2022
- Primary completion31 May 2027 (estimated)
- Study completion1 Dec 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.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Cancer Research, Czech Republic, University Hospital Olomouc
- Responsible party
- Sponsor
- Investigators
- Marian Hajduch, MD., PhD., Study director, IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774561
- Sponsor's protocol ID
- NU-23-03-00255
- Status last verified
- Nov 2026
- First submitted
- 24 Jan 2023
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsies - a Possible Tool for Treatment Monitoring and Early Recurrence Detection in HPV-associated Diseases
- ClinicalTrials.gov ID
- NCT05774561
- Acronym / sponsor ID
- NU-23-03-00255
- Keywords
- human papillomavirus, HPV, liquid biopsies, cervicovaginal swab, cervical cancer, oropharyngeal cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech RepublicUniversity, hospital or other
- Collaborators
- National Institute for Cancer Research, Czech Republic, University Hospital Olomouc
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 17 Mar 2023 (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 trial will evaluate the possible benefits and the performance of liquid biopsies in HPV-associated cancer treatment monitoring. This study aims to find a combination of an adequately sensitive and specific sampling method and biomarkers for early risk stratification of disease recurrence.
Detailed description
Although the cancers associated with human papillomavirus (HPV) infection are currently almost entirely preventable, a significant part of the Czech population suffers from these diseases. The most common HPV-associated cancers are cervical cancer (CC) and oropharyngeal cancer (OPC). In these, the severe problem is successful monitoring of the treatment effectiveness and early disease recurrence detection. It is, therefore, necessary to find a non-invasive method that could specifically and timely identify patients at risk of recurrence and thus enable patients with quality and less burdensome medical care. The use of liquid biopsies (LB), which the study focuses on, looks most promising.
This study is divided into two arms, with each arm including both prospective and retrospective parts. Into prospective parts will be enrolled only newly diagnosed CC/HSIL (high-grade cervical intraepithelial lesions) or OPC patients. In contrast, the retrospective part will enroll patients in post-treatment follow-up. In both study arms, fresh tumor tissues will be sampled from patients in prospective parts before treatment, and archived Formalin Fixed Paraffin Embedded (FFPE) tissue samples will be obtained from patients of retrospective parts.
Regarding the liquid biopsies, pre \& post-treatment sampling of LB will be performed. Subsequently, regular sample acquisition will be performed during follow-up according to the standard medical practice in both prospective and retrospective parts. Oropharyngeal swabs, gargle lavage,exhaled breath condensate (EBC), and blood samples will be collected from OPC patients. Blood collection and self-sampling of cervicovaginal swabs will be performed in patients with CC/HSIL. All samples, excluding blood samples, will be tested for the presence of the most prevalent high-risk and low-risk HPV genotypes. The circulating tumor (ct) HPV DNA will be monitored in blood samples. Additionally, the mutation profile of the primary tumors will be examined in fresh and FFPE samples.
The dynamics of HPV DNA will be monitored throughout all follow-up samples and correlated with the obtained clinical data. A created panel of frequently altered genes will be used for alterations monitoring in liquid biopsies. In the final analysis of laboratory and clinical results, we assume a finding of a clinically usable algorithm that could predict the risk of disease recurrence for a particular patient.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A - Oropharyngeal cancer patients | – | Diagnostic Test: Arm A - Diagnostic test: HPV detection in liquid biopsiesIn total, approx. 200 OPC cancer patients will be enrolled in the study Arm A, with both prospective and retrospective parts enrolling 100 OPC patients. The Arm A will enroll patients from the Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Olomouc. Pre-treatment primary samples of fresh or FFPE tissue samples will be collected. Liquid biopsies (gargle lavage, oropharyngeal smear, breath condensate, and blood sample) will be collected. Obtained samples will be tested by CE-IVD (device complies with European in vitro diagnostic Directive) marked HPV diagnostic test. A laboratory developed digital droplet PCR assay will be used for ct HPV DNA detection. Sampling will be performed at pre \& post treatment check-ups, and every 3 months for 3 years and every 6 months for 2 years. |
| Arm B - Cervical cancer patients | – | Diagnostic Test: Arm B - Diagnostic test: HPV detection in liquid biopsiesInto the study Arm B will be enrolled 80 patients with CC and 120 patients with HSIL, and 80 patients will be enrolled into the retrospective part. The Arm B will enroll patients from the Department of Gynecology and Obstetrics, University Hospital Olomouc. Pre-treatment primary samples of fresh or FFPE tissue samples will be collected. Liquid biopsies (cervicovaginal swab and blood sample) will be collected. Obtained samples will be tested by CE-IVD marked HPV diagnostic test. A laboratory developed digital droplet PCR assay will be used for ct HPV DNA detection. Sampling will be performed at pre \& post treatment check-ups, and every 3 months for 2 years and every 6 months for 3 years. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oropharyngeal cancer patients, Cervical cancer patients
Key inclusion criteria (1 listed)
- Women diagnosed with CC/HSIL. Men and women diagnosed with OPC. Patients must agree with study enrollment and must sign study informed consent.
Key exclusion criteria (1 listed)
- No exclusion criteria are set.
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 |
|---|---|---|
| Arm A - Diagnostic test: HPV detection in liquid biopsiesPatients will be asked to perform self-collection of gargle lavage samples. Oropharyngeal swabs, breath condensate, and blood samples will be taken by trained clinicians. | Diagnostic test | Arm A - Oropharyngeal cancer patients |
| Arm B - Diagnostic test: HPV detection in liquid biopsiesPatients will be asked to perform cervicovaginal self-sampling using Evalyn Brush. Blood samples will be taken by trained clinicians. | Diagnostic test | Arm B - Cervical cancer patients |
Primary outcome
Dynamics of HPV infection in cervical cancer patients during 4-year follow-up.
Time frame: 4 years
HPV-status in liquid biopsies collected during pre-treatment, post-treatment and follow-up check-ups.
Dynamics of HPV infection in oropharyngeal cancer patients during 4-year follow-up.
Time frame: 4 years
HPV-status in liquid biopsies collected during pre-treatment, post-treatment and follow-up check-ups.
Dynamics of circulating tumor (ct) HPV DNA in oropharyngeal cancer patients.
Time frame: 4 years
Correlation of plasmatic ct HPV DNA level with cancer patient´s prognosis.
Dynamics of circulating tumor (ct) HPV DNA in cervical cancer patients
Time frame: 4 years
Correlation of plasmatic ct HPV DNA level with patient´s prognosis
Analysis of the mutational landscape of oropharyngeal cancer cases.
Time frame: 4 years
Correlation of tumor mutational burden (TMB) with cancer patient´s prognosis.
Analysis of the mutational landscape of cervical cancer cases.
Time frame: 4 years
Correlation of tumor mutational burden (TMB) with cancer patient´s prognosis.
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 Nov 2026.
- 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.
Marian Hajduch, MD., PhD. study director
IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry
1 site 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 Cervical Dysplasia, run by The Institute of Molecular and Translational Medicine, Czech Republic at 1 site in Czechia.
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: looking for participants now, as of the sponsor's last update on 5 Nov 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 Czechia. 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 Marian Hajduch, MD., PhD. (+420 585 632 083, marian.hajduch@upol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamics of HPV infection in cervical cancer patients during 4-year follow-up. (time frame: 4 years). The study lists 6 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 5 Nov 2026.