Heterogeneity of Oral Carcinogenesis: From PrEneoplasia to Invasive Squamous Cell Carcinoma
HOPES
1 other identifier
interventional
150
1 country
1
Brief 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. Additionally, the study will evaluate the effectiveness of non-invasive cytobrushes as a diagnostic tool compared to traditional biopsies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2026
CompletedFirst Posted
Study publicly available on registry
May 12, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2035
May 12, 2026
May 1, 2026
8.8 years
May 5, 2026
May 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
4 years
Secondary Outcomes (4)
Description of the functional interactions among tumor, stromal, and immune subpopulations.
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.
4 years
Identification of prognostic and predictive biomarkers for oral squamous cell carcinoma evolution.
4 years
Evaluation of cytobrushing as a non-invasive sampling method for diagnostic yield equivalence to tissue biopsy in OPMD patients.
4 years
Study Arms (3)
OSCC clinical-biological cohort
OTHERA clinical-biological cohort of 50 patients with OSCC. Blood sample and biospecimen at the time of a standard surgery.
OPMD clinical-biological cohort
OTHERA clinical-biological cohort of 50 patients with OPMD. Biospecimen at the time of a standard care.
Cyto-OPMD clinical-biological cohort
OTHERA clinical-biological cohort of 50 patients with OPMD (Cyto-OPMD). Biospecimen via cytobrush and biopsy at the time of a standard care.
Interventions
Blood sampling (6 mL), taken from a routine biological exam.
* 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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Léon Bérard
Lyon, 69008, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe Zrounba, M.D.
philippe.zrounba@lyon.unicancer.fr
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2026
First Posted
May 12, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
March 1, 2035
Study Completion (Estimated)
March 1, 2035
Last Updated
May 12, 2026
Record last verified: 2026-05