Circulating Tumor CellCTCONCT04696744
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)
An observational study of Circulating Tumor Cell and Oropharyngeal Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Circulating Tumor Cell, Oropharyngeal Cancer
- What is being tested?
- CTC detection
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2021to 17 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult subjects with squamous cell carcinoma of the oropharynx with a curative treatment scheduled
Who may be able to join
- 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
Who cannot join
- Carcinoma of the nasopharynx, larynx, oral cavity or hypopharynx
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
France1 site
Service ORL Chirurgie Cervico-faciale (Pr Philippe CERUSE)
Lyon, 69004
About this study
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.
Read more
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
- Being tested
- CTC detection
- Keywords
- CTC, Oropharynx, HNSCC
- Medical subject headings
- Neoplastic Cells, Circulating, Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTC detectionBiological
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
| Study group | Role | What they receive |
|---|---|---|
| CTCO | adults with squamous cell carcinoma of the oropharynx with a curative aim Receives: Biological: CTC detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start23 Jun 2021
- Primary completion17 Mar 2023
- Study completion17 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulating Tumor CellStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philouze Pierre, Dr, Principal investigator, Service ORL Chirurgie Cervico-faciale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696744
- Sponsor's protocol ID
- 69HCL20_0446
- Acronym
- CTCO
- Status last verified
- Mar 2026
- First submitted
- 21 Dec 2020
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04696744
- Acronym / sponsor ID
- CTCO / 69HCL20_0446
- Conditions
- Circulating Tumor Cell, Oropharyngeal Cancer
- Keywords
- CTC, Oropharynx, HNSCC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTCO | – | Biological: CTC detectionadults with squamous cell carcinoma of the oropharynx with a curative aim |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult subjects with squamous cell carcinoma of the oropharynx with a curative treatment scheduled
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Carcinoma of the nasopharynx, larynx, oral cavity or hypopharynx
- Pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTC detectionThe 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 | Biological | CTCO |
Primary outcome
characterization of CTCs
Time frame: Day 1
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.
characterization of CTCs
Time frame: Month 4
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.
characterization of CTCs
Time frame: Month 10
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.
characterization of CTCs
Time frame: Month 18
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philouze Pierre, Dr principal investigator
Service ORL Chirurgie Cervico-faciale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circulating Tumor Cell and Oropharyngeal Cancer, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
characterization of CTCs (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.