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 | Completed

• 1 other identifier: 69HCL20_0446
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Circulating Tumor Cell; Oropharyngeal Cancer

Keywords

CTC; Oropharynx; HNSCC

Outcome Measures

Primary Outcomes (4)

• characterization of CTCs

  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.

  Day 1

• characterization of CTCs

  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.

  Month 4

• characterization of CTCs

  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.

  Month 10

• characterization of CTCs

  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.

  Month 18

Study Arms (1)

CTCO

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

Biological: CTC detection

Interventions

CTC detection BIOLOGICAL

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

CTCO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

adult subjects with squamous cell carcinoma of the oropharynx with a curative treatment scheduled

You may qualify if:

• Over 18 years of age
• Squamous cell carcinoma proven on biopsy
• Oropharyngeal location
• Curative treatment by Surgery followed by radiotherapy (chemotherapy) Or Radiochemotherapy Or Induction chemotherapy (+/- surgery) + radiotherapy
• Did not object to their participation in the study

You may not qualify if:

• Carcinoma of the nasopharynx, larynx, oral cavity or hypopharynx
• Pregnant or breastfeeding woman

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service ORL Chirurgie Cervico-faciale (Pr Philippe CERUSE)

Lyon, 69004, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Neoplastic Cells, Circulating; Oropharyngeal Neoplasms; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Philouze Pierre, Dr

  Service ORL Chirurgie Cervico-faciale

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: January 6, 2021
• Study Start: June 23, 2021
• Primary Completion: March 17, 2023
• Study Completion: March 17, 2023
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)