Oral Squamous Cell CarcinomasHOPESNCT07579507
Heterogeneity of Oral Carcinogenesis: From PrEneoplasia to Invasive Squamous Cell Carcinoma
A study testing Biospecimen and Blood sampling in people with Oral Squamous Cell Carcinomas and Oral Potentially Malignant Disorder, run by Centre Leon Berard at 1 site in France.
Trial summary
The goal of this project is to characterise the heterogeneity of all cell populations (tumour cells, stromal and immune microenvironment) present in the tumor and their normal (and OPMD) counterparts by scRNAseq in OSCC patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Squamous Cell Carcinomas, Oral Potentially Malignant Disorder
- What is being tested?
- Biospecimen and Blood sampling
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2026to Mar 2035
- 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
- I1: Male or female at least 18 years old.
- I2: For Cohort A: patients with OSCC who undergo surgery. For cohorts B and C: patients with OPMD.
- I3: Patient who has agreed to participate in this research and sign consent.
- I4: Patient affiliated to a medical insurance.
- I5: Patient who have not previously received any anticancer treatment (radiotherapy, chemotherapy, or immunotherapy)
Who cannot join
- NI1: For cohorts B and C: Patient at high risk of bleeding, such as those receiving anticoagulant or antiplatelet therapy, those with coagulation disorders, or those with a history of severe bleeding within the two weeks prior to enrollment.
- NI2: Pregnant or nursing woman.
- NI3: Contraindication to general anesthesia.
- NI4: Suspicion of rare tumor of particular histology other than squamous cell carcinoma (Sarcoma...).
- NI5: Patient under curatorial or guardianship or placed under the protection of justice.
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
Centre Léon Bérard
Lyon, 69008
Philippe Zrounba, M.D., 04 69 85 60 82, philippe.zrounba@lyon.unicancer.fr
Pierre-Eric Roux, M.D., +33(0)478782638, pierre-eric.roux@lyon.unicancer.fr
About this study
The goal of this project is to characterise the heterogeneity of all cell populations (tumour cells, stromal and immune microenvironment) present in the tumor and their normal (and OPMD) counterparts by scRNAseq in OSCC patients. Additionally, the study will evaluate the effectiveness of non-invasive cytobrushes as a diagnostic tool compared to traditional biopsies.
Read the detailed description
Epidermoid carcinomas of upper aerodigestive tract are the 8th most common cancers in the world. Worldwide, this represents more than 500.000 cases per year and 20.000 cases per year in France (statistics 2018-2020). Among these cancers, oral squamous cell carcinoma (OSCC) are the most common location, leading to significant morbidity and mortality.
OSCC treatment is based on surgery and/or radiotherapy and/or chemotherapy. Immune Check point Inhibitors (ICIs) targeting PD-1 have been approved for recurrent and metastasic OSCC. However, only 15-20% of these patients are treated thanks to this anti-PD-1. Thus, there is a real need to improve the efficacy of ICIs in the treatment of HNSCC. The scRNAseq is a method which allows to study the tumoral heterogeneity, the microenvironment and the dynamic and regulation mecanisms in cells cancer. This technology could improve patient stratification, identify pronostic biomarkers, constitute an important tool in the therapeutical take care and lead to understand tumoral evolution and develop new prevention strategies.
The project is organized into three cohorts:
- Cohort A (OSCC): Designed to compare malignant cells directly with their healthy and pre-malignant counterparts within the same patient.
- Cohort B (OPMD): Focused on patients with potentially malignant lesions but no active cancer.
- Cohort C (Cyto-OPMD): Validating a non-invasive sampling method. The goal is to determine if a cytobrush can provide the same high-quality genomic data as a biopsy.
By combining these approaches, the project aims to characterize the heterogeneity of all cell populations (tumour cells, stromal and immune microenvironment) to improve the global management of patients.
- Being tested
- Biospecimen, Blood sampling
- Keywords
- scRNAseq, Heterogeneity of all cell population, OPMD, OSCC, cytobrush, RNAseq bulk
- 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.
BiospecimenProcedure or surgery
- 1 or 2 tumoral specimen (depending on the size of the tumor).
- 1 specimen of the healthy oral mucosa.
- 1 OPMD specimen if applicable. The biospecimens will be collected at the time of the surgery organised for the standard routine medical care.
Blood samplingProcedure or surgery
Blood sampling (6 mL), taken from a routine biological exam.
BiospecimenProcedure or surgery
- 1 OPMD lesion specimen.
- 1 specimen of the healthy oral mucosa (facultative). The biospecimens will be collected during standard routine medical care.
BiospecimenProcedure or surgery
- 1 cytobrush sample.
- 1 OPMD lesion specimen. Samples must be collected in sequence (first the cytobrush, then the biopsy collected during standard routine medical care.).
| Study group | Role | What they receive |
|---|---|---|
| OSCC clinical-biological cohort | Other | A clinical-biological cohort of 50 patients with OSCC. Blood sample and biospecimen at the time of a standard surgery. Receives: Procedure: Biospecimen; Procedure: Blood sampling |
| OPMD clinical-biological cohort | Other | A clinical-biological cohort of 50 patients with OPMD. Biospecimen at the time of a standard care. Receives: Procedure: Biospecimen |
| Cyto-OPMD clinical-biological cohort | Other | A clinical-biological cohort of 50 patients with OPMD (Cyto-OPMD). Biospecimen via cytobrush and biopsy at the time of a standard care. Receives: Procedure: Biospecimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the heterogeneity of all cell populations (tumor cells, stromal and immune microenvironment) in OSCC and OPMD using scRNA-seq.
Evaluation of transcriptomic data from all cell populations to define gene expression profiles and specific signatures.
Measured: 4 years
Secondary outcomes (4)
Description of the functional interactions among tumor, stromal, and immune subpopulations.
Describe the functional interactions between tumor, stromal, and immune subpopulations identified by scRNA-seq and bulk RNA-seq using in vitro models and co-culture assays. Cellular responses will be assessed using transcriptomic analysis and phenotypic characterization.
Measured: 4 years
Correlation between refined patient stratification (based on tumor, stromal and immune sub-population) and the impact on the response to ex-vivo treatments.
Correlation between tumor, stromal and immune sub-populations likely to refine patient stratification and the impact on the response to ex-vivo treatments.
Measured: 4 years
Identification of prognostic and predictive biomarkers for oral squamous cell carcinoma evolution.
Correlation of gene expression profiles with disease progression to identify prognostic and predictive biomarkers in scRNAseq and bulk RNAseq datasets.
Measured: 4 years
Evaluation of cytobrushing as a non-invasive sampling method for diagnostic yield equivalence to tissue biopsy in OPMD patients.
Comparative assessment of cytobrushing and tissue biopsy to establish diagnostic equivalence and evaluate the reduction of clinical constraints in the sampling of OPMD lesions.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study startJun 2026 (estimated)
- Primary completionMar 2035 (estimated)
- Study completionMar 2035 (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 CarcinomasStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Zrounba, M.D., Principal investigator, philippe.zrounba@lyon.unicancer.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579507
- Sponsor's protocol ID
- ET26-077 HOPES
- Acronym
- HOPES
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 12 May 2026
- 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heterogeneity of Oral Carcinogenesis: From PrEneoplasia to Invasive Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07579507
- Acronym / sponsor ID
- HOPES / ET26-077 HOPES
- Keywords
- scRNAseq, Heterogeneity of all cell population, OPMD, OSCC, cytobrush, RNAseq bulk
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Mar 2035 (estimated)
- Study completion
- Mar 2035 (estimated)
- First posted
- 12 May 2026 (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 goal of this project is to characterise the heterogeneity of all cell populations (tumour cells, stromal and immune microenvironment) present in the tumor and their normal (and OPMD) counterparts by scRNAseq in OSCC patients. Additionally, the study will evaluate the effectiveness of non-invasive cytobrushes as a diagnostic tool compared to traditional biopsies.
Detailed description
Epidermoid carcinomas of upper aerodigestive tract are the 8th most common cancers in the world. Worldwide, this represents more than 500.000 cases per year and 20.000 cases per year in France (statistics 2018-2020). Among these cancers, oral squamous cell carcinoma (OSCC) are the most common location, leading to significant morbidity and mortality.
OSCC treatment is based on surgery and/or radiotherapy and/or chemotherapy. Immune Check point Inhibitors (ICIs) targeting PD-1 have been approved for recurrent and metastasic OSCC. However, only 15-20% of these patients are treated thanks to this anti-PD-1. Thus, there is a real need to improve the efficacy of ICIs in the treatment of HNSCC. The scRNAseq is a method which allows to study the tumoral heterogeneity, the microenvironment and the dynamic and regulation mecanisms in cells cancer. This technology could improve patient stratification, identify pronostic biomarkers, constitute an important tool in the therapeutical take care and lead to understand tumoral evolution and develop new prevention strategies.
The project is organized into three cohorts:
- Cohort A (OSCC): Designed to compare malignant cells directly with their healthy and pre-malignant counterparts within the same patient.
- Cohort B (OPMD): Focused on patients with potentially malignant lesions but no active cancer.
- Cohort C (Cyto-OPMD): Validating a non-invasive sampling method. The goal is to determine if a cytobrush can provide the same high-quality genomic data as a biopsy.
By combining these approaches, the project aims to characterize the heterogeneity of all cell populations (tumour cells, stromal and immune microenvironment) to improve the global management of patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OSCC clinical-biological cohort | Other | Procedure: Biospecimen, Procedure: Blood samplingA clinical-biological cohort of 50 patients with OSCC. Blood sample and biospecimen at the time of a standard surgery. |
| OPMD clinical-biological cohort | Other | Procedure: BiospecimenA clinical-biological cohort of 50 patients with OPMD. Biospecimen at the time of a standard care. |
| Cyto-OPMD clinical-biological cohort | Other | Procedure: BiospecimenA clinical-biological cohort of 50 patients with OPMD (Cyto-OPMD). Biospecimen via cytobrush and biopsy at the time of a standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- I1: Male or female at least 18 years old.
- I2: For Cohort A: patients with OSCC who undergo surgery. For cohorts B and C: patients with OPMD.
- I3: Patient who has agreed to participate in this research and sign consent.
- I4: Patient affiliated to a medical insurance.
- I5: Patient who have not previously received any anticancer treatment (radiotherapy, chemotherapy, or immunotherapy)
Key exclusion criteria (5 listed)
- NI1: For cohorts B and C: Patient at high risk of bleeding, such as those receiving anticoagulant or antiplatelet therapy, those with coagulation disorders, or those with a history of severe bleeding within the two weeks prior to enrollment.
- NI2: Pregnant or nursing woman.
- NI3: Contraindication to general anesthesia.
- NI4: Suspicion of rare tumor of particular histology other than squamous cell carcinoma (Sarcoma...).
- NI5: Patient under curatorial or guardianship or placed under the protection of justice.
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 |
|---|---|---|
| Biospecimen* 1 or 2 tumoral specimen (depending on the size of the tumor). * 1 specimen of the healthy oral mucosa. * 1 OPMD specimen if applicable. The biospecimens will be collected at the time of the surgery organised for the standard routine medical care. | Procedure or surgery | OSCC clinical-biological cohort |
| Blood samplingBlood sampling (6 mL), taken from a routine biological exam. | Procedure or surgery | OSCC clinical-biological cohort |
| Biospecimen* 1 OPMD lesion specimen. * 1 specimen of the healthy oral mucosa (facultative). The biospecimens will be collected during standard routine medical care. | Procedure or surgery | OPMD clinical-biological cohort |
| Biospecimen* 1 cytobrush sample. * 1 OPMD lesion specimen. Samples must be collected in sequence (first the cytobrush, then the biopsy collected during standard routine medical care.). | Procedure or surgery | Cyto-OPMD clinical-biological cohort |
Primary outcome
Characterization of the heterogeneity of all cell populations (tumor cells, stromal and immune microenvironment) in OSCC and OPMD using scRNA-seq.
Time frame: 4 years
Evaluation of transcriptomic data from all cell populations to define gene expression profiles and specific signatures.
4 secondary outcomes
Description of the functional interactions among tumor, stromal, and immune subpopulations.
Time frame: 4 years
Correlation between refined patient stratification (based on tumor, stromal and immune sub-population) and the impact on the response to ex-vivo treatments.
Time frame: 4 years
Identification of prognostic and predictive biomarkers for oral squamous cell carcinoma evolution.
Time frame: 4 years
Evaluation of cytobrushing as a non-invasive sampling method for diagnostic yield equivalence to tissue biopsy in OPMD patients.
Time frame: 4 years
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 12 May 2026.
Related trials for Oral Squamous Cell Carcinomas
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
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.
Philippe Zrounba, M.D. principal investigator
philippe.zrounba@lyon.unicancer.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen and Blood sampling in people with Oral Squamous Cell Carcinomas and Oral Potentially Malignant Disorder, run by Centre Leon Berard 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 12 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 Philippe Zrounba, M.D. (04 69 85 60 82 ext. +33, philippe.zrounba@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of the heterogeneity of all cell populations (tumor cells, stromal and immune microenvironment) in OSCC and OPMD using scRNA-seq. (time frame: 4 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 12 May 2026.