NCT07579507|Not Yet Recruiting
Heterogeneity of Oral Carcinogenesis: From PrEneoplasia to Invasive Squamous Cell Carcinoma
HOPES
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HOPES
Sponsor study identifier
interventional
150
1 country
1
Study Start
June 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 5, 2026
Actual (reported)May 12, 2026
Actual (reported)June 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
A clinical-biological cohort of 50 patients with OSCC. Blood sample and biospecimen at the time of a standard surgery.
A clinical-biological cohort of 50 patients with OPMD. Biospecimen at the time of a standard care.
A clinical-biological cohort of 50 patients with OPMD (Cyto-OPMD). Biospecimen via cytobrush and biopsy at the time of a standard care.
* 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 sampling (6 mL), taken from a routine biological exam.
Centre Léon Bérard
Lyon, 69008, France
Philippe Zrounba, M.D.
philippe.zrounba@lyon.unicancer.fr
First Submitted
May 5, 2026
First Posted
May 12, 2026
Study Start
June 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 2035
EstimatedcDNA and Residual Disease After Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinomas
* 1 OPMD lesion specimen. * 1 specimen of the healthy oral mucosa (facultative). The biospecimens will be collected during standard routine medical care.
* 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.).
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Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 12, 2026
Record last verified: 2026-05
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Source: ClinicalTrials.gov.
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