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NCT Number: NCT06861036

Heterogeneity of Oral Squamous Cell Carcinoma Analysis by Single Cell RNA Sequencing

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Léon Bérard

Lyon, 69008, France

Location contact

Philippe Zrounba, M.D.

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Biospecimen

Procedure
  • 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 sampling

Procedure

Blood sampling (6 mL), taken from a routine biological exam.

Primary outcomes

  1. 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

Secondary outcomes

  1. Description of the functional interactions among tumor, stromal, and immune subpopulations identified by scRNAseq

    Time frame: 3 years

    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.

  2. 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

    Correlation between tumor, stromal and immune sub-populations likely to refine patient stratification and the impact on the response to ex-vivo treatments.

  3. Identification of prognostic and predictive biomarkers for oral squamous cell carcinoma evolution

    Time frame: 3 years

    Correlation of gene expression profiles with disease progression to identify prognostic and predictive biomarkers in scRNAseq and bulk RNAseq datasets

Study contacts

Contact information is provided by the study sponsor or research team.

Karène Mahtouk, Ph.D.

CONTACT

[email protected]

04 69 85 60 82 ext. +33

Philippe Zrounba, M.D.

CONTACT

[email protected]

(0)4 69 85 60 82 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Acronym: HOASIS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 6, 2025
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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