Head and Neck CancerHPVNGSNCT06133790
Profiles of Expression in HPV+ Versus HPV Head and Neck Cancers
An observational study of Head and Neck Cancer, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Squamous cell cancers of the head and neck are classically correlated to excessive consumption of alcohol and tobacco and have a rather poor prognosis. However, the incidence of Head and Neck cancers in patients without alcohol-smoking risk factor has continued to increase in recent years, in relation to more and more… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- PCR - Immunohistochemistry - Immunolabelling
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 30 Jun 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with Head and Neck cancer and HPV diagnosis
Who may be able to join
- Patient with oropharyngeal squamous cell carcinoma or the oral cavity histologically proven.
- Primary tumor for which a biopsy or excision is required available and sufficient to carry out molecular analysis
Who cannot join
- Patient with Head and Neck cancer other than oropharyngeal or oral cavity squamous cells carcinomas
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Genomic Alterations and Profiles of Expression in HPV+ Versus HPV Head and Neck Cancers
Squamous cell cancers of the head and neck are classically correlated to excessive consumption of alcohol and tobacco and have a rather poor prognosis. However, the incidence of Head and Neck cancers in patients without alcohol-smoking risk factor has continued to increase in recent years, in relation to more and more frequent HPV contamination.
Some studies show a difference in the expression of certain genes within the two groups of tumors (HPV+ and HPV-) including some that confer sensitivity to certain chemotherapies and others to radiotherapy. However, patients with HPV+ Head and Neck cancers are treated according to the same referential as HPV- Head and Neck cancers. There is therefore a real need for studies identifying predictive markers in order to be able to offer patients a more effective suitable and less invasive treatment.
Read the detailed description
Head and neck cancers are the sixth most common cancer common worldwide causing more than 380,000 deaths each year. More than 90% of these cancers are carcinomas epidermoids arising from the mucosal surfaces of the cavity oral cavity, oropharynx and larynx.
Squamous cell cancers of the head and neck are classically correlated with risk factors linked to excessive consumption of alcohol and tobacco and have a rather poor prognosis (mainly HPV (Human Papilloma Virus) negative patients).
However, the incidence of Head and Neck cancers in patients without alcohol-smoking risk factor has continued to increase in recent years, in relation to more and more frequent HPV contamination. Evolution of oral sexual practices seems to be one of the explanations for the progression of these cases of oropharyngeal squamous cell carcinoma and oral cavity HPV positive.
Some studies show a difference in the expression of certain genes within the two groups of tumors (HPV+ and HPV-) including some that confer sensitivity to certain chemotherapies (CCND1, TYMS) and others to radiotherapy (RBBP4). However, patients with HPV+ Head and Neck cancers are treated according to the same referential as HPV- Head and Neck cancers. There is therefore a real need for studies identifying predictive markers in order to be able to offer patients a more effective suitable and less invasive treatment. This is the context of this research project.
- Conditions
- Head and Neck Cancer
- Being tested
- PCR - Immunohistochemistry - Immunolabelling
- 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.
PCR - Immunohistochemistry - ImmunolabellingGenetic
Genetic analysis will be conducted on biopsy to define molecular profile of head and neck tumors
| Study group | Role | What they receive |
|---|---|---|
| HPV + Group | Patients with positive HPV diagnosis Receives: Genetic: PCR - Immunohistochemistry - Immunolabelling | |
| HPV - Group | Patients with negative HPV diagnosis Receives: Genetic: PCR - Immunohistochemistry - Immunolabelling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular profile of oropharyngeal or oral cavity HPV positive and negative tumors
Molecular profile of tumors will be established with analysis of 87 "Hotspot" genes, full length analysis of 48 genes, copy number analysis of 43 genes and gene fusion (inter and intra genic) of 51 genes.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start1 Jan 2024
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Why it stopped: Feasibility issue
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 GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme PARIS, MD, Principal investigator, Hôpital privé de Clairval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133790
- Sponsor's protocol ID
- 2023-A00936-39
- Acronym
- HPVNGS
- Status last verified
- Aug 2026
- First submitted
- 23 Oct 2023
- Last updated
- 20 Aug 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Genomic Alterations and Profiles of Expression in HPV+ Versus HPV Head and Neck Cancers
- ClinicalTrials.gov ID
- NCT06133790
- Acronym / sponsor ID
- HPVNGS / 2023-A00936-39
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Feasibility issue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 15 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.
Squamous cell cancers of the head and neck are classically correlated to excessive consumption of alcohol and tobacco and have a rather poor prognosis. However, the incidence of Head and Neck cancers in patients without alcohol-smoking risk factor has continued to increase in recent years, in relation to more and more frequent HPV contamination.
Some studies show a difference in the expression of certain genes within the two groups of tumors (HPV+ and HPV-) including some that confer sensitivity to certain chemotherapies and others to radiotherapy. However, patients with HPV+ Head and Neck cancers are treated according to the same referential as HPV- Head and Neck cancers. There is therefore a real need for studies identifying predictive markers in order to be able to offer patients a more effective suitable and less invasive treatment.
Detailed description
Head and neck cancers are the sixth most common cancer common worldwide causing more than 380,000 deaths each year. More than 90% of these cancers are carcinomas epidermoids arising from the mucosal surfaces of the cavity oral cavity, oropharynx and larynx.
Squamous cell cancers of the head and neck are classically correlated with risk factors linked to excessive consumption of alcohol and tobacco and have a rather poor prognosis (mainly HPV (Human Papilloma Virus) negative patients).
However, the incidence of Head and Neck cancers in patients without alcohol-smoking risk factor has continued to increase in recent years, in relation to more and more frequent HPV contamination. Evolution of oral sexual practices seems to be one of the explanations for the progression of these cases of oropharyngeal squamous cell carcinoma and oral cavity HPV positive.
Some studies show a difference in the expression of certain genes within the two groups of tumors (HPV+ and HPV-) including some that confer sensitivity to certain chemotherapies (CCND1, TYMS) and others to radiotherapy (RBBP4). However, patients with HPV+ Head and Neck cancers are treated according to the same referential as HPV- Head and Neck cancers. There is therefore a real need for studies identifying predictive markers in order to be able to offer patients a more effective suitable and less invasive treatment. This is the context of this research project.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPV + Group | – | Genetic: PCR - Immunohistochemistry - ImmunolabellingPatients with positive HPV diagnosis |
| HPV - Group | – | Genetic: PCR - Immunohistochemistry - ImmunolabellingPatients with negative HPV diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Head and Neck cancer and HPV diagnosis
Key inclusion criteria (2 listed)
- Patient with oropharyngeal squamous cell carcinoma or the oral cavity histologically proven.
- Primary tumor for which a biopsy or excision is required available and sufficient to carry out molecular analysis
Key exclusion criteria (1 listed)
- Patient with Head and Neck cancer other than oropharyngeal or oral cavity squamous cells carcinomas
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 |
|---|---|---|
| PCR - Immunohistochemistry - ImmunolabellingGenetic analysis will be conducted on biopsy to define molecular profile of head and neck tumors | Genetic | HPV + Group, HPV - Group |
Primary outcome
Molecular profile of oropharyngeal or oral cavity HPV positive and negative tumors
Time frame: 1 day
Molecular profile of tumors will be established with analysis of 87 "Hotspot" genes, full length analysis of 48 genes, copy number analysis of 43 genes and gene fusion (inter and intra genic) of 51 genes.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 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. This study is not recruiting at the moment.
Jérôme PARIS, MD principal investigator
Hôpital privé de Clairval
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 GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 2 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: withdrawn, as of the sponsor's last update on 20 Aug 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 France. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Molecular profile of oropharyngeal or oral cavity HPV positive and negative tumors (time frame: 1 day). 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 20 Aug 2026.