Oral Squamous Cell CarcinomasHOASISNCT06861036
Heterogeneity of Oral Squamous Cell Carcinoma Analysis by Single Cell RNA Sequencing
A study testing Biospecimen and Blood sampling in people with Oral Squamous Cell Carcinomas, 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 leucoplasic) 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
- 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
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2025to 15 May 2028
- 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. Patient with OSCC and undergoing surgery at the Centre Léon Bérard.
- I3. Patient who has agreed to participate in this research and sign consent.
- I4. Patient affiliated to a medical insurance.
Who cannot join
- NI1. Pregnant or nursing woman.
- NI2. Contraindication to general anesthesia.
- NI3. Suspicion of rare tumor of particular histology other than squamous cell carcinoma (Sarcoma...).
- NI4. 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., philippe.zrounba@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 leucoplasic) counterparts by scRNAseq in OSCC patients.
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 aim of the study is to characterise the heterogeneity of all cell populations (tumour cells, stromal and immune microenvironment) present in the tumor and their normal (and leucoplasic) counterparts by scRNAseq in OSCC patients.
- Conditions
- Oral Squamous Cell Carcinomas
- Being tested
- Biospecimen, Blood sampling
- Keywords
- scRNAseq, Heterogeneity of all cell population, OSCC
- 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 leucoplakia 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
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 (tumour cells, stromal and immune microenvironment) present in the tumor and their normal (and leucoplasic) counterparts by scRNAseq in OSCC patients.
Transcriptomic data from scRNAseq for all cell populations
Measured: 3 years
Secondary outcomes (3)
Description of the functional interactions among tumor, stromal, and immune subpopulations identified by scRNAseq
Describe the functional interactions between tumor, stromal, and immune subpopulations using ex vivo culture models and co-culture assays. Cellular responses will be assessed using transcriptomic analysis and phenotypic characterization.
Measured: 3 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: 3 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: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start15 May 2025 (estimated)
- Primary completion15 May 2028 (estimated)
- Study completion15 May 2028 (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
- Not applicable
- Intervention model
- Single group
- Model description
- A clinical-biological cohort of patients with OSCC. Samples: * 1 blood sample (6 mL) * 1 or 2 tumoral specimen (depending on the size of the tumor) * 1 specimen of the healthy oral mucosa * 1 leucoplakia specimen if applicable. The biospecimens will be collected at the time of the surgery scheduled in the standard routine medical care.
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT06861036
- Sponsor's protocol ID
- ET22-338 HOASIS
- Acronym
- HOASIS
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 6 Mar 2025
- 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 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heterogeneity of Oral Squamous Cell Carcinoma Analysis by Single Cell RNA Sequencing
- ClinicalTrials.gov ID
- NCT06861036
- Acronym / sponsor ID
- HOASIS / ET22-338 HOASIS
- Conditions
- Oral Squamous Cell Carcinomas
- Keywords
- scRNAseq, Heterogeneity of all cell population, OSCC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 15 May 2028 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 6 Mar 2025 (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 leucoplasic) counterparts by scRNAseq in OSCC patients.
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 aim of the study is to characterise the heterogeneity of all cell populations (tumour cells, stromal and immune microenvironment) present in the tumor and their normal (and leucoplasic) counterparts by scRNAseq in OSCC patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A clinical-biological cohort of patients with OSCC. Samples: * 1 blood sample (6 mL) * 1 or 2 tumoral specimen (depending on the size of the tumor) * 1 specimen of the healthy oral mucosa * 1 leucoplakia specimen if applicable. The biospecimens will be collected at the time of the surgery scheduled in the standard routine medical care.
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- I1. Male or female at least 18 years old.
- I2. Patient with OSCC and undergoing surgery at the Centre Léon Bérard.
- I3. Patient who has agreed to participate in this research and sign consent.
- I4. Patient affiliated to a medical insurance.
Key exclusion criteria (4 listed)
- NI1. Pregnant or nursing woman.
- NI2. Contraindication to general anesthesia.
- NI3. Suspicion of rare tumor of particular histology other than squamous cell carcinoma (Sarcoma...).
- NI4. 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 leucoplakia specimen if applicable. The biospecimens will be collected at the time of the surgery organised for the standard routine medical care. | Procedure or surgery | Clinical-biological cohort |
| Blood samplingBlood sampling (6 mL), taken from a routine biological exam. | Procedure or surgery | Clinical-biological cohort |
Primary outcome
Characterization of the heterogeneity of all cell populations (tumour cells, stromal and immune microenvironment) present in the tumor and their normal (and leucoplasic) counterparts by scRNAseq in OSCC patients.
Time frame: 3 years
Transcriptomic data from scRNAseq for all cell populations
3 secondary outcomes
Description of the functional interactions among tumor, stromal, and immune subpopulations identified by scRNAseq
Time frame: 3 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: 3 years
Identification of prognostic and predictive biomarkers for oral squamous cell carcinoma evolution
Time frame: 3 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 6 Mar 2025.
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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.
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, 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 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: opening soon, as of the sponsor's last update on 6 Mar 2025. 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. ((0)4 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 (tumour cells, stromal and immune microenvironment) present in the tumor and their normal (and leucoplasic) counterparts by scRNAseq in OSCC patients. (time frame: 3 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 6 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.