Head and Neck CancerAIRC-ChioccaNCT06706973
Profiling and Targeting Epigenetic Marks to Improve Diagnosis and Therapeutic Approaches in Head and Neck Cancer
An observational study of Head and Neck Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial summary
Investigators have recently shown that epigenetic remodelling enzymes, such as HDAC inhibitors, are feasible drugs in HNC (8, 9). Preliminary data are indicating some deregulated epigenetics marks suggesting the corresponding histone modifiers as possible targets for the treatment of HNC, providing an attractive and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 6 Mar 2024to 4 Apr 2030
- How long will I take part?
- 24 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients that will undergo surgical tumor removal at the Otolaryngology - head and neck surgery unit of the IEO. Samples will be collected from at least 60 HNC primary tumors
Who may be able to join
None listed.
Who cannot join
- Previous radiotherapy, chemotherapy or immunotherapy for HNC
- Unable to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
European Institute of oncology
Milan, MI, 20141
About this study
Investigators have recently shown that epigenetic remodelling enzymes, such as HDAC inhibitors, are feasible drugs in HNC (8, 9). Preliminary data are indicating some deregulated epigenetics marks suggesting the corresponding histone modifiers as possible targets for the treatment of HNC, providing an attractive and feasible option to build upon. Our overarching hypothesis is that unique histone marks distinguish HPV+ and HPV- HNC and that specific histone modifiers are novel mediators of HNC tumorigenesis in an HPV specific manner
Read the detailed description
Head and neck cancer (HNC) is a highly heterogeneous disease, involving diverse anatomical sites including oral cavity, larynx and oropharynx. HNC risk factors include tobacco smoking and alcohol consumption and, especially for the subtype of oropharyngeal cancers (OPC), human papillomavirus (HPV) infection
- Conditions
- Head and Neck Cancer
- Keywords
- PROFILING AND TARGETING EPIGENETIC MARKS, HEAD AND NECK CANCER
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patient with head and neck SCC | Anatomic location: oral cavity, larynx, oropharynx |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROFILING AND TARGETING EPIGENETIC MARKS TO IMPROVE DIAGNOSIS AND THERAPEUTIC APPROACHES IN HEAD AND NECK CANCER
define and fully characterize histone Post-Translational Modifications (hPTMs) and differentially expressed chromatin modifiers in HPV+ vs HPV- HNC through cutting-edge methodologies
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start6 Mar 2024
- Primary completion4 Apr 2030 (estimated)
- Study completion4 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro
- Responsible party
- Sponsor
- Investigators
- Susanna Chiocca, Principal investigator, Istituto Europeo di Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706973
- Sponsor's protocol ID
- IEO 1972
- Acronym
- AIRC-Chiocca
- Status last verified
- Oct 2024
- First submitted
- 22 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profiling and Targeting Epigenetic Marks to Improve Diagnosis and Therapeutic Approaches in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT06706973
- Acronym / sponsor ID
- AIRC-Chiocca / IEO 1972
- Conditions
- Head and Neck Cancer
- Keywords
- PROFILING AND TARGETING EPIGENETIC MARKS, HEAD AND NECK CANCER
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 4 Apr 2030 (estimated)
- Study completion
- 4 Apr 2030 (estimated)
- First posted
- 27 Nov 2024 (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.
Investigators have recently shown that epigenetic remodelling enzymes, such as HDAC inhibitors, are feasible drugs in HNC (8, 9). Preliminary data are indicating some deregulated epigenetics marks suggesting the corresponding histone modifiers as possible targets for the treatment of HNC, providing an attractive and feasible option to build upon. Our overarching hypothesis is that unique histone marks distinguish HPV+ and HPV- HNC and that specific histone modifiers are novel mediators of HNC tumorigenesis in an HPV specific manner
Detailed description
Head and neck cancer (HNC) is a highly heterogeneous disease, involving diverse anatomical sites including oral cavity, larynx and oropharynx. HNC risk factors include tobacco smoking and alcohol consumption and, especially for the subtype of oropharyngeal cancers (OPC), human papillomavirus (HPV) infection
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with head and neck SCC | – | –Anatomic location: oral cavity, larynx, oropharynx |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients that will undergo surgical tumor removal at the Otolaryngology - head and neck surgery unit of the IEO. Samples will be collected from at least 60 HNC primary tumors
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Previous radiotherapy, chemotherapy or immunotherapy for HNC
- Unable to provide written informed consent
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
PROFILING AND TARGETING EPIGENETIC MARKS TO IMPROVE DIAGNOSIS AND THERAPEUTIC APPROACHES IN HEAD AND NECK CANCER
Time frame: 2 years
define and fully characterize histone Post-Translational Modifications (hPTMs) and differentially expressed chromatin modifiers in HPV+ vs HPV- HNC through cutting-edge methodologies
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 27 Nov 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.
Susanna Chiocca principal investigator
Istituto Europeo di Oncologia
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 Head and Neck Cancer, run by European Institute of Oncology 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 0 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: looking for participants now, as of the sponsor's last update on 27 Nov 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 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?
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 Susanna Chiocca, Doctor (00390257488835, susanna.chiocca@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROFILING AND TARGETING EPIGENETIC MARKS TO IMPROVE DIAGNOSIS AND THERAPEUTIC APPROACHES IN HEAD AND NECK CANCER (time frame: 2 years). 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 27 Nov 2024.