Oropharyngeal Squamous Cell CarcinomaNCT06138483
A New Mutational and Epigenetic Signature to Predict Early OPSCC Relapse
An observational study of Oropharyngeal Squamous Cell Carcinoma, run by Centro di Riferimento Oncologico - Aviano at 5 sites in Italy.
Trial summary
Inclusion of new biomarkers to improve the personalized treatment approach for HPV-positive and -negative oropharyngeal squamous cell carcinoma (OPSCC) patients is urgently needed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Squamous Cell Carcinoma
- How many people
- 267 participants
- Where
- 5 sitesItaly
- Study dates
- 19 Apr 2019to 30 Jun 2025
- 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
- All sexes
- Adult, Older adult
Study population: Caucasian patients, with newly diagnosed, previously untreated, histologically confirmed stage III-IVa OPSCC
Who may be able to join
- newly diagnosed, previously untreated, histologically confirmed stage III-IVa OPSCC, according to AJCC 7th Edition,
- managed with definitive treatment modality (either radical surgery plus adjuvant radiotherapy ± chemotherapy or definitive chemo-radiotherapy)
- minimum follow up of 2 years or who had disease recurrence within 2 years after the end of treatment.
- neoplastic lesion contains ≥ 70% neoplastic cells
Who cannot join
- Patients:
- with distant metastases at diagnosis,
- who have been managed with palliative intent;
- with previous history of head and neck cancer are not eligible
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites, 5 recruiting
- Recruiting
Centro di Riferimento Oncologico (CRO), IRCCS
Aviano
Elisabetta Fratta, MD, efratta@cro.it
Elisabetta Fratta, PhD
- Recruiting
Ospedale San Martino di Belluno - ULSS 1 Dolomiti
Belluno
Carlo Furlan, MD, carlo.furlan@aulss1.veneto.it
- Recruiting
Ospedale dell'Angelo - Mestre - Ulss 3 Serenissima
Mestre
Doriano Politi, MD, doriano.politi@aulss3.veneto.it
- Recruiting
Ospedale Santa Maria degli Angeli - ASFO
Pordenone
Vittorio Giacomarra, vittorio.giacomarra@asfo.sanita.fvg.it
- Recruiting
Ospedale di Treviso - ULSS 2 Marca Trevigiana
Treviso
Paolo Boscolo-Rizzo, MD, segorltv@aulss2.veneto.it
About this study
Inclusion of new biomarkers to improve the personalized treatment approach for HPV-positive and -negative oropharyngeal squamous cell carcinoma (OPSCC) patients is urgently needed. Emerging evidences suggest that mutations in epigenetic regulators, as well as epigenetic changes, deeply influence the biology of OPSCC, thus representing attractive targets for the definition of novel molecular markers for this malignancy. Based on these considerations, our project aims to retrospectively identify a new mutational and epigenetic signature to identify OPSCC patients at high risk of early relapse, and to set up a new multicenter prospective study in order to validate it
- Conditions
- Oropharyngeal Squamous Cell Carcinoma
- Keywords
- Oropharyngeal Squamous Cell Carcinoma
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What is being measured
The primary outcome is the main question the study is designed to answer.
risk of recurrence
risk of recurrence in patients with a negative prognostic epigenetic signature compared to patients with a positive one
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start19 Apr 2019
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal Squamous Cell CarcinomaStudies 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
- Prospective
- Enrolment
- 267 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabetta Fratta, PhD, Principal investigator, Centro di Riferimento Oncologico (CRO), IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138483
- Sponsor's protocol ID
- CRO 2019.13
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 18 Nov 2023
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Mutational and Epigenetic Signature to Predict Early OPSCC Relapse
- ClinicalTrials.gov ID
- NCT06138483
- Acronym / sponsor ID
- CRO 2019.13
- Conditions
- Oropharyngeal Squamous Cell Carcinoma
- Keywords
- Oropharyngeal Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 267 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 18 Nov 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.
Inclusion of new biomarkers to improve the personalized treatment approach for HPV-positive and -negative oropharyngeal squamous cell carcinoma (OPSCC) patients is urgently needed. Emerging evidences suggest that mutations in epigenetic regulators, as well as epigenetic changes, deeply influence the biology of OPSCC, thus representing attractive targets for the definition of novel molecular markers for this malignancy. Based on these considerations, our project aims to retrospectively identify a new mutational and epigenetic signature to identify OPSCC patients at high risk of early relapse, and to set up a new multicenter prospective study in order to validate it
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Caucasian patients, with newly diagnosed, previously untreated, histologically confirmed stage III-IVa OPSCC
Key inclusion criteria (4 listed)
- newly diagnosed, previously untreated, histologically confirmed stage III-IVa OPSCC, according to AJCC 7th Edition,
- managed with definitive treatment modality (either radical surgery plus adjuvant radiotherapy ± chemotherapy or definitive chemo-radiotherapy)
- minimum follow up of 2 years or who had disease recurrence within 2 years after the end of treatment.
- neoplastic lesion contains ≥ 70% neoplastic cells
Key exclusion criteria (4 listed)
- with distant metastases at diagnosis,
- who have been managed with palliative intent;
- with previous history of head and neck cancer are not eligible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
risk of recurrence
Time frame: 18 months
risk of recurrence in patients with a negative prognostic epigenetic signature compared to patients with a positive one
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- 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. This study is not recruiting at the moment.
Elisabetta Fratta, PhD principal investigator
Centro di Riferimento Oncologico (CRO), IRCCS
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharyngeal Squamous Cell Carcinoma, run by Centro di Riferimento Oncologico - Aviano at 5 sites 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 4 inclusion and 4 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Contact Elisabetta Fratta, PhD (+390434659569, efratta@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
risk of recurrence (time frame: 18 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 18 Nov 2023.