PREDICTIVE BIOMARKERSNCT06097936
New Prognostic and Predictive Biomarkers for HPV-associated Oropharyngeal Cancer
An observational study of PREDICTIVE BIOMARKERS and Evaluation of HPV-specific E5 Transcript Expression in a Cohort of Patients With HPV-associated OPC, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
The study involves the coexistence of a retrospective part, in which a group of patients with HPV-associated OPC for whom follow-up data of at least 2 years after diagnosis are available, designed in order to evaluate the expression of HPV16-specific E5 transcript as well as that of pEGFR and HLA, and a multicenter… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- PREDICTIVE BIOMARKERS, Evaluation of HPV-specific E5 Transcript Expression in a Cohort of Patients With HPV-associated OPC, HPV 16 Positive Oropharyngeal Tumors (OPC)
- What is being tested?
- HPV-ASSOCIATED OROPHARYNGEAL CANCER
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2021to 1 Apr 2024
- Phase
- Observational
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The control group will be enlisted from among the subjects referred to the IRE outpatient clinic and/or the outpatient clinics of the LILT Provincial Committees collaborating with the Project to undergo a screening/checkup visit. Samples will be collected in a mouthwash (i.e., Listerine) and stored in suitable solution to preserve nucleic acids (i.e., PreservCyt Transport Medium) and sent by courier from the peripheral centers to the IFOs where they will be appropriately analyzed.
Who may be able to join
- Male subjects
- age > 18 years
- current and/or former smokers
- reporting at least 5 (Souza 2017) lifetime oral sex partners
- Written informed consent
Who cannot join
- Oral pathology
- inability to understand and sign an informed consent form
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
"Regina Elena" National Cancer Institute
Rome, 00144
Aldo Venuti, MD, ND, aldo.venuti@ifo.it
About this study
The study involves the coexistence of a retrospective part, in which a group of patients with HPV-associated OPC for whom follow-up data of at least 2 years after diagnosis are available, designed in order to evaluate the expression of HPV16-specific E5 transcript as well as that of pEGFR and HLA, and a multicenter prospective part, involving the enrollment of a control group, enrolled at the ENT outpatient clinic of the IRE and the outpatient clinics of the relevant LILT provincial committees, to better elucidate the role of HPV16-E5 in identifying potentially transforming infections due to the presence of HPV.
- Conditions
- PREDICTIVE BIOMARKERS, Evaluation of HPV-specific E5 Transcript Expression in a Cohort of Patients With HPV-associated OPC, HPV 16 Positive Oropharyngeal Tumors (OPC)
- Being tested
- HPV-ASSOCIATED OROPHARYNGEAL CANCER
- Keywords
- HPV 16, oropharyngeal tumors (OPC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV-ASSOCIATED OROPHARYNGEAL CANCERDiagnostic test
The study involves the coexistence of a retrospective part, in which a group of patients with HPV-associated OPC for whom follow-up data of at least 2 years after diagnosis are available, designed in order to evaluate the expression of HPV16-specific E5 transcript as well as that of pEGFR and HLA, and a multicenter prospective part, involving the enrollment of a control group, enrolled at the ENT outpatient clinic of the IRE and the outpatient clinics of the relevant LILT provincial committees, to better elucidate the role of HPV16-E5 in identifying potentially transforming infections due to the presence of HPV.
| Study group | Role | What they receive |
|---|---|---|
| HPV Patients | Not described Receives: Diagnostic Test: HPV-ASSOCIATED OROPHARYNGEAL CANCER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of specific mRNA for the E5 oncoprotein in HPV-associated OPC samples
The expected results concern the identification of OPC subgroups correlated with the expression of HPV16 E5.RNA will be extracted from FFPE with a commercial RNeasy kit (QIAGEN) and reverse transcribed into cDNA.
The synthesized cDNA will be subjected to real-time PCR with specific primers, already designed by the Beacon Design software (BioRad) to include the splicing site (880-3358) of the specific E5 transcript.
The relative amount of genes will be determined by the ΔΔCt method normalized to housekeeping genes.
Measured: Sample collection period: 6 months Total duration of the study: 12 months
Secondary outcomes (1)
Presence of specific mRNA for the E5 oncoprotein in HPV-associated OPC samples
the primary outcome is necessary for a subsequent larger study in which the expression of E5 will be evaluated together with that of EGFR and HLA and associated with prognosis and different responses to therapy
Measured: Sample collection period: 6 months Total duration of the study: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start15 Mar 2021
- Primary completion13 Dec 2022
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PREDICTIVE BIOMARKERSStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, Lega Italiana per la Lotta contro i Tumori
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097936
- Sponsor's protocol ID
- RS1443/20(2442)
- Status last verified
- Jun 2023
- First submitted
- 28 Mar 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Prognostic and Predictive Biomarkers for HPV-associated Oropharyngeal Cancer
- ClinicalTrials.gov ID
- NCT06097936
- Acronym / sponsor ID
- RS1443/20(2442)
- Conditions
- PREDICTIVE BIOMARKERS, Evaluation of HPV-specific E5 Transcript Expression in a Cohort of Patients With HPV-associated OPC, HPV 16 Positive Oropharyngeal Tumors (OPC)
- Keywords
- HPV 16, oropharyngeal tumors (OPC)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- University of California, San Diego, Lega Italiana per la Lotta contro i Tumori
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 24 Oct 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.
The study involves the coexistence of a retrospective part, in which a group of patients with HPV-associated OPC for whom follow-up data of at least 2 years after diagnosis are available, designed in order to evaluate the expression of HPV16-specific E5 transcript as well as that of pEGFR and HLA, and a multicenter prospective part, involving the enrollment of a control group, enrolled at the ENT outpatient clinic of the IRE and the outpatient clinics of the relevant LILT provincial committees, to better elucidate the role of HPV16-E5 in identifying potentially transforming infections due to the presence of HPV.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV Patients | – | Diagnostic Test: HPV-ASSOCIATED OROPHARYNGEAL CANCER |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The control group will be enlisted from among the subjects referred to the IRE outpatient clinic and/or the outpatient clinics of the LILT Provincial Committees collaborating with the Project to undergo a screening/checkup visit. Samples will be collected in a mouthwash (i.e., Listerine) and stored in suitable solution to preserve nucleic acids (i.e., PreservCyt Transport Medium) and sent by courier from the peripheral centers to the IFOs where they will be appropriately analyzed.
Key inclusion criteria (5 listed)
- Male subjects
- age > 18 years
- current and/or former smokers
- reporting at least 5 (Souza 2017) lifetime oral sex partners
- Written informed consent
Key exclusion criteria (2 listed)
- Oral pathology
- inability to understand and sign an informed consent form
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-ASSOCIATED OROPHARYNGEAL CANCERThe study involves the coexistence of a retrospective part, in which a group of patients with HPV-associated OPC for whom follow-up data of at least 2 years after diagnosis are available, designed in order to evaluate the expression of HPV16-specific E5 transcript as well as that of pEGFR and HLA, and a multicenter prospective part, involving the enrollment of a control group, enrolled at the ENT outpatient clinic of the IRE and the outpatient clinics of the relevant LILT provincial committees, to better elucidate the role of HPV16-E5 in identifying potentially transforming infections due to the presence of HPV. | Diagnostic test | HPV Patients |
Primary outcome
Presence of specific mRNA for the E5 oncoprotein in HPV-associated OPC samples
Time frame: Sample collection period: 6 months Total duration of the study: 12 months
The expected results concern the identification of OPC subgroups correlated with the expression of HPV16 E5.RNA will be extracted from FFPE with a commercial RNeasy kit (QIAGEN) and reverse transcribed into cDNA. The synthesized cDNA will be subjected to real-time PCR with specific primers, already designed by the Beacon Design software (BioRad) to include the splicing site (880-3358) of the specific E5 transcript. The relative amount of genes will be determined by the ΔΔCt method normalized to housekeeping genes.
1 secondary outcome
Presence of specific mRNA for the E5 oncoprotein in HPV-associated OPC samples
Time frame: Sample collection period: 6 months Total duration of the study: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: Undecided
Related trials for PREDICTIVE BIOMARKERS
RecruitingObservational study
Bariatric Surgery and Gut Microbiota Changes Over Time
Obese Patients, Obese Patients With Bariatric Surgery
Not yet recruitingObservational study
Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection
Renal Transplantation; Complication, Renal Transplant
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
RecruitingPhase 2/3
Tissue Analysis After Tumor Ablation for Liver Metastases Leading to Immediate Retreatment
Liver Metastases
RecruitingObservational study
Prospective Multicenter Cohort Study of Clinical and Molecular Biomarkers in Colorectal Cancer
Colorectal Neoplasms
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.
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 PREDICTIVE BIOMARKERS and Evaluation of HPV-specific E5 Transcript Expression in a Cohort of Patients With HPV-associated OPC, run by Regina Elena Cancer Institute at 1 site in Italy.
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 5 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: status not confirmed, as of the sponsor's last update on 24 Oct 2023. 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of specific mRNA for the E5 oncoprotein in HPV-associated OPC samples (time frame: Sample collection period: 6 months Total duration of the study: 12 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 24 Oct 2023.