Neoplasms

All Conditions

Symptoms and General Pathology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Carcinoma

Carcinoma, Squamous Cell

Neoplastic Cells, Circulating

Oropharyngeal Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Neoplasm Metastasis

Neoplastic Processes

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

All Drugs and Chemicals

Antibodies

Immunoglobulins

adults with squamous cell carcinoma of the oropharynx with a curative aim

The collection and analysis of CTCs will be carried out in the following 6 steps: A blood sample will be taken: a maximum volume of 30 ml on 3 x 10 ml BD Vacutainer® EDTA tubes is required for the study.

CTCs will be enumerated and characterized by immunofluorescence after immunostaining with the following antibodies: anticytokeratin, anti-CD44, anti-N-cadherin and anti-PD-L1.

• - Secondary criterion(s) : Different tumor and clinical parameters will be analysed to find a correlation with CTC detection Gene expression profiles will be analyzed using the RNAseq single-cell at different times: before treatment, at interim times, and in case of relapse in order to establish correlations between patients at high risk of relapse and their molecular profiles

CTC detection

Philouze Pierre, Dr

Gauthier Arnaud, Dr

PHILOUZE Pierre, Dr

GAUTHIER Arnaud, Dr

Head and neck cancers (HNSCC) are primarily squamous cell cancers represented by tumors of the upper aerodigestive tract. Locally advanced stages (stages III and IV) account for 50 to 70% of all presentations. The three main risk factors are smoking, alcohol and oropharyngeal infection with human papilloma virus (HPV).

Apart from HPV status, there is no biomarker for the prognosis in HSNCC patients. Circulating Tumor Cells (CTCs) can provide "real-time" information on tumor behavior and are already used in various cancers (colon, lung). Their detection has limited sensitivity and biomarkers cannot be used for early diagnosis, but may be useful during follow-up to assess local, regional or metastatic early tumor recurrence.

By using blood samples at different times (at diagnosis, after initial treatment and during follow-up), we will be able to measure the variation in quantification and establish a predictive role of these CTCs for the response to treatment.

Our hypothesis is that CTCs may have a key role, in addition to clinical and radiological examination, in detecting early tumor relapse.

We believe that the joint consideration of clinical parameters, treatment strategy and quantification of CTCs could optimize patient follow-up and management.

The CTC extraction system, ClearCell® FX from Biolidics, is an automated microfluidic enrichment system. It has the advantage of recovering fully intact and viable CTCs from a standard blood sample. The gentle sorting principle allows to preserve cell integrity and thus the expression of surface antigens. The CTCs thus isolated can then be re-cultured or analyzed by immunostaining. This high-performance technique, in operation since December 2017 in the Biochemistry Department of Pr Claire Rodriguez-Lafrasse (HCL), has demonstrated its usefulness in lung cancer.

Transcriptomic analysis of CTCs can be performed at the scale of a cell after isolation of the CTCs. CTCs can then be sequenced in RNAseq either in bulk (pool of cells) or cell by cell on our Illumina (Nextseq) sequencer, in order to define the heterogeneity of the tumor. Transcriptome analysis then provides information on the state of the cell as to its position in the epithelio-mesenchymal transition thanks to a molecular signature by phenotype. A priori-free characterization is therefore possible thanks to the RNAseq single-cell. This highly sensitive and innovative technique will allow the study of the gene expression profile of CTCs.

Prospective Study for the Prognostic and Predictive Role of Circulating Tumor Cells in Patients With Oropharyngeal Squamous Cell Carcinoma: CTCO (Circulating Tumor Cells in the Oropharynx)

The CTCs will be extracted using Biolidic's ClearCell automaton which uses a microfluidic technique.

The CTCs will be enumerated and characterized in immunofluorescence after immunostaining with the following antibodies: anticytokeratin, anti-CD44, anti-N-cadherin and anti-PD-L1.

Hospices Civils de Lyon

Digestive System Diseases

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Immunomodulating Agents

Advancd gastric cancer patients received anti-HER2 \& immunotherapy ± chemotherapy

Advancd gastric cancer patients received anti-HER2 ± chemotherapy.

Tissue and peripheral blood sample of 100 gastric cancer patients will be collected at the baseline and time point response of therapy.

Samples including blood and tissue collection

Peripheral blood collected from patients will be administrated to CTC detection.

DNA extraction from patients' peripheral blood will be measured by 741 panel DNA sequence.

ctDNA detection

Tissue collected from patients will be digested into single cell suspension and administrated to 10×genomics single cell RNA sequence.

10×genomics single cell RNA sequence

DNA will be extracted from patients' tissue and administrated to whole exon sequence.

Whole exon sequence

Peripheral blood collected from patients will be administrated to proximity extension assay .

Proteomics detection

Zhang Xiaotian, MD

Shen Lin, Professor

Shen Lin, professor

Dynamic multiomics explore the efficacy and mechanism of anti-HER2 \& immunotherapy of HER2 Positive GC

The investigators will recruit 100 HER2 positive advanced gastric cancer patients.Blood and tumor tissue will be collected at treatment baseline, every time point response till disease progression. All samples will be processed by next-generation sequence , 10× genomics single-cell sequence ,whole exon sequence, proteome detection and CTC detection to explore the efficacy and mechanism of anti-HER2 \& immunotherapy of HER2 positive GC.

Dynamic Multiomics Evaluation of Anti-HER2 and Immunotherapy in HER2 Positive Gastric Cancer

Numbers of CTC and proportions of HER2 or PD-L1 positive CTC collected at treatment baseline and every time point response will be calculated and recorded. Proportions of HER2 and PD-L1 positive CTC will be compared between two groups.

NGS will be proceeded to detect the ctDNA variations features at treatment baseline and every time point response will be recorded and compared between two groups.

single cell digested from tumor tissue will be administrated to 10× genomics single cell transcriptome sequence. Proportions of lymphocytes, stromal cells, tumor cells assessed by single cell transcriptome sequence at treatment baseline, the second time point response and disease progression time point will be recorded and compared between two groups.

DNA extracted from tumor tissue will be administrated to whole exon sequence.Variation features at treatment baseline, the second time point response and disease progression time point will be recorded and compared between two groups.

96 tumor associated proteins' expression level of tumor at treatment baseline, second time point response and disease progression time point will be recorded and compared between two groups.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Study for the Prognostic and Predictive Role of Circulating Tumor Cells in Patients With Oropharyngeal Squamous Cell Carcinoma: CTCO (Circulating Tumor Cells in the Oropharynx)	NCT04696744	Circulating Tum... Oropharyngeal C...	CTC detection	18 Years -	Hospices Civils de Lyon
Prospective Study for the Prognostic and Predictive Role of Circulating Tumor Cells in Patients With Oropharyngeal Squamous Cell Carcinoma: CTCO (Circulating Tumor Cells in the Oropharynx)	NCT04696744	Circulating Tum... Oropharyngeal C...	CTC detection	18 Years -	Hospices Civils de Lyon
Dynamic Multiomics Evaluation of Anti-HER2 and Immunotherapy in HER2 Positive Gastric Cancer	NCT05348161	HER2 Positive A...	Samples includi... CTC detection ctDNA detection 10×genomics sin... Whole exon sequ... Proteomics dete...	18 Years - 80 Years	Peking University

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