Heterogeneity of Oral Carcinogenesis: From PrEneoplasia to Invasive Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen, Blood sampling, Biospecimen, Biospecimen.
- Who it may be relevant to
- Registry conditions: Oral Squamous Cell Carcinomas, Oral Potentially Malignant Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure 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 Blood sampling
Blood sampling (6 mL), taken from a routine biological exam. - Procedure Biospecimen
* 1 OPMD lesion specimen. * 1 specimen of the healthy oral mucosa (facultative). The biospecimens will be collected during standard routine medical care. - Procedure 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.).
Primary outcome measures
- 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]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- Centre Léon Bérard — Lyon
Identifiers
NCT: NCT07579507 · ET26-077 HOPES