Oral Squamous Cell CarcinomaEPSACONCT05791149
Epigenetic Biomarkers in the Saliva for the Diagnosis of Squamous Cells Carcinoma of the Oral Cavity
A study testing saliva tube in people with Oral Squamous Cell Carcinoma and Maxillo-facial Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Head and neck squamous cell carcinoma (HNSCC) are malignant tumors originating from the epithelial mucosa of the upper aerodigestive tract. The oral cavity is the most frequent location of HNSCC (oral squamous cell carcinoma: OSCC). Tobacco use and alcohol consumption are the greatest risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Squamous Cell Carcinoma, Maxillo-facial Surgery, Biomarkers
- What is being tested?
- saliva tube
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2022to Oct 2027
- Phase
- Interventional
- 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
Who may be able to join
- Patient group:
- Patients from the maxillofacial surgery department treated for a histologically confirmed squamous cell carcinoma of the oral cavity
- Patients whose first-line treatment decision at the multidisciplinary meeting in the service of Maxillofacial Surgery is surgery
- Patients who have not yet been treated surgically or by neoadjuvant treatment
- Patients over 18 years old
- Patients who have provided free and informed consent in writing
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- Patients benefiting from a social security scheme
- Control group:
- Patients in the maxillofacial surgery department not covered for head and neck cancer
- Patients over 18 years old
- Patients who have provided free and informed consent in writing
- Patients benefiting from a social security scheme
- Control group homogeneous with the patient group according to age, sex, tobacco and alcohol consumption
Who cannot join
- Patients with other types of cancer
- Patients under the age of 18
- Pregnant or breastfeeding women
- Patients under guardianship, curators, legal protection or deprived of liberty
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Amiens University Hospital
Amiens, Picardie, 80054
Zuzana Saidak, MD, 03 22 08 70 84, saidak.zuzana@chu-amiens.fr
Stéphanie Dakpé, Pr
About this study
Head and neck squamous cell carcinoma (HNSCC) are malignant tumors originating from the epithelial mucosa of the upper aerodigestive tract. The oral cavity is the most frequent location of HNSCC (oral squamous cell carcinoma: OSCC). Tobacco use and alcohol consumption are the greatest risk factors. The Hauts de France region has one of the highest incidence rates of OSCC. The overall survival of patients with OSCC remains low, with a 5-year overall survival rate of around 60%. In addition to the oncological prognosis, OSCCs and their treatment have a significant impact on the quality of life of patients. An early diagnosis of OSCC is recommended, but it remains difficult. It can be for example challenging to diagnose OSCC in a context of oral premalignant lesions. Identifying objective biomarkers of malignancy would be an advantage and would allow better progress in the field of precision medicine and surgery for these tumors.
The investigators propose to establish the diagnostic use of an optimized DNA methylation profile detected in the saliva of OSCC patients by comparing these epigenetic marks before and after tumor resection.
Read more
The investigators will construct a consolidated signature of 4 genes whose DNA is subject to methylation and gene expression is restricted to cancer cells, by crossing TCGA analysis with single-cell analysis (single-cell RNA sequencing).
The investigators propose to analyse DNA methylation of the corresponding genes in the saliva of n=30 OSCC patients recruited for primary surgical resection in the Department of Maxillofacial Surgery vs controls. In addition, the investigators will examine the methylation profiles before / after complete excisional surgery of OSCC. This pilot study will aim to validate the analysis of DNA methylation markers in saliva of OSCC, with the aim of improving the diagnostic precision of OSCC and, secondly, to compare these markers before and after treatment by primary surgery.
- Conditions
- Oral Squamous Cell Carcinoma, Maxillo-facial Surgery, Biomarkers, Saliva, DNA Methylation, Epigenetics
- Being tested
- saliva tube
- Keywords
- Oral Squamous Cell Carcinoma, Maxillo-facial surgery, Biomarkers, Saliva, DNA Methylation, epigenetics
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saliva tubeDiagnostic test
1 tube of saliva (~2 ml) will be collected from all patients enrolled in the study. For operated OSCC patients a second tube will be collected during the routine hospital visit 4 weeks after surgery
| Study group | Role | What they receive |
|---|---|---|
| OSCC patients | Experimental | Not described Receives: Diagnostic Test: saliva tube |
| controls | Active comparator | Not described Receives: Diagnostic Test: saliva tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of methylated gene in both groups : control and OSCC patients
Measured: one year
Secondary outcomes (2)
Percentage of methylated gene in OSCC patients before surgery
Measured: one year
Percentage of methylated gene in OSCC patients after surgery
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start3 Mar 2022
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791149
- Sponsor's protocol ID
- PI2022_843_0042
- Acronym
- EPSACO
- Status last verified
- May 2026
- First submitted
- 17 Mar 2023
- Last updated
- 13 May 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic Biomarkers in the Saliva for the Diagnosis of Squamous Cells Carcinoma of the Oral Cavity
- ClinicalTrials.gov ID
- NCT05791149
- Acronym / sponsor ID
- EPSACO / PI2022_843_0042
- Conditions
- Oral Squamous Cell Carcinoma, Maxillo-facial Surgery, Biomarkers, Saliva, DNA Methylation, Epigenetics
- Keywords
- Oral Squamous Cell Carcinoma, Maxillo-facial surgery, Biomarkers, Saliva, DNA Methylation, epigenetics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 30 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.
Head and neck squamous cell carcinoma (HNSCC) are malignant tumors originating from the epithelial mucosa of the upper aerodigestive tract. The oral cavity is the most frequent location of HNSCC (oral squamous cell carcinoma: OSCC). Tobacco use and alcohol consumption are the greatest risk factors. The Hauts de France region has one of the highest incidence rates of OSCC. The overall survival of patients with OSCC remains low, with a 5-year overall survival rate of around 60%. In addition to the oncological prognosis, OSCCs and their treatment have a significant impact on the quality of life of patients. An early diagnosis of OSCC is recommended, but it remains difficult. It can be for example challenging to diagnose OSCC in a context of oral premalignant lesions. Identifying objective biomarkers of malignancy would be an advantage and would allow better progress in the field of precision medicine and surgery for these tumors.
The investigators propose to establish the diagnostic use of an optimized DNA methylation profile detected in the saliva of OSCC patients by comparing these epigenetic marks before and after tumor resection.
The investigators will construct a consolidated signature of 4 genes whose DNA is subject to methylation and gene expression is restricted to cancer cells, by crossing TCGA analysis with single-cell analysis (single-cell RNA sequencing).
The investigators propose to analyse DNA methylation of the corresponding genes in the saliva of n=30 OSCC patients recruited for primary surgical resection in the Department of Maxillofacial Surgery vs controls. In addition, the investigators will examine the methylation profiles before / after complete excisional surgery of OSCC. This pilot study will aim to validate the analysis of DNA methylation markers in saliva of OSCC, with the aim of improving the diagnostic precision of OSCC and, secondly, to compare these markers before and after treatment by primary surgery.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSCC patients | Experimental | Diagnostic Test: saliva tube |
| controls | Active comparator | Diagnostic Test: saliva tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient group:
- Patients from the maxillofacial surgery department treated for a histologically confirmed squamous cell carcinoma of the oral cavity
- Patients whose first-line treatment decision at the multidisciplinary meeting in the service of Maxillofacial Surgery is surgery
- Patients who have not yet been treated surgically or by neoadjuvant treatment
- Patients over 18 years old
Key exclusion criteria (4 listed)
- Patients with other types of cancer
- Patients under the age of 18
- Pregnant or breastfeeding women
- Patients under guardianship, curators, legal protection or deprived of liberty
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 |
|---|---|---|
| saliva tube1 tube of saliva (~2 ml) will be collected from all patients enrolled in the study. For operated OSCC patients a second tube will be collected during the routine hospital visit 4 weeks after surgery | Diagnostic test | OSCC patients, controls |
Primary outcome
Percentage of methylated gene in both groups : control and OSCC patients
Time frame: one year
2 secondary outcomes
Percentage of methylated gene in OSCC patients before surgery
Time frame: one year
Percentage of methylated gene in OSCC patients after surgery
Time frame: one year
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 13 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing saliva tube in people with Oral Squamous Cell Carcinoma and Maxillo-facial Surgery, run by Centre Hospitalier Universitaire, Amiens 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 13 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: looking for participants now, as of the sponsor's last update on 13 May 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?
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 Zuzana SAIDAK, PhD (03 22 08 70 84, saidak.zuzana@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of methylated gene in both groups : control and OSCC patients (time frame: one year). 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 13 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.