Head and Neck CancerNCT06199947
Study of the Role of Oncostatin M in Head and Neck Squamous Cell Carcinoma
A study testing Biopsies and Blood collection in people with Head and Neck Cancer and Cytokine, run by Poitiers University Hospital.
Trial summary
The ROMCOR study will be interested in the impact and the role of oncostatin M (OSM), a cytokine belonging to IL-6 superfamily, in the physiopathology of head and neck squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Head and Neck Cancer, Cytokine
- What is being tested?
- Biopsies and Blood collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Dec 2025
- Phase
- Interventional
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years of age;
- with suspected squamous cell carcinoma of the oral cavity, oropharynx or pharyngolarynx (any stage);
- with healthy, untreated contralateral mucosa and no contraindications to biopsy;
- with no history of any type of cancer;
- with a WHO performance status index of 0 to 2 inclusive ;
- able to receive treatment according to current European Society of Medical Oncology guidelines ;
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- without guardianship, curatorship or subordination;
- benefiting from a Social Security scheme or benefiting from one through a third party;
- have given informed consent to participate in the study.
Who cannot join
- previously pre-treated in the ear, nose, throat sphere by radiotherapy or having already received anti-cancer chemotherapy;
- on long-term immunosuppressive therapy, defined as taking an immunosuppresseur, identified as such in the ATC classification, for 7 days, cortico-therapy > 7.5mg/day for more than 3 months, treatment or history of anti-CD20 treatment within the year, or regular plasmatic exchange or gamma globulin infusion;
- benefiting from enhanced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection;
- pregnant or breast-feeding women of childbearing age (menopause must be documented and more than 2 years old) who refuse or do not have an effective method of contraception (hormonal/mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy) for the duration of the study.
- final diagnosis of non-squamous cell carcinoma
Trial locations and contacts
No sites are listed yet.
About this study
The ROMCOR study will be interested in the impact and the role of oncostatin M (OSM), a cytokine belonging to IL-6 superfamily, in the physiopathology of head and neck squamous cell carcinoma. The study team will study the impact of the presence of OSM and its main receptor OSM-R2 on several survival outcomes (overall survival, progression free survival) by multiple technics such as immunohistochemistry, transcriptomic in situ assays and spatial transcriptomic. Furthermore, the study team will try to show a link between serum level of several cytokines and in situ tumoral OSM.
- Conditions
- Head and Neck Cancer, Cytokine
- Being tested
- Biopsies and Blood collection
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsies and Blood collectionOther
Each participant will have 2 additionnal biopsies during his/her diagnostic endoscopy plus two blood test during his/her inclusion
| Study group | Role | What they receive |
|---|---|---|
| Samples | Experimental | Not described Receives: Other: Biopsies and Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To analyze the relative expression of OSM, several inflammatory cytokines and their receptors in head and neck squamous cell carcinomas (SCC).
The relative expression of transcripts for OSM, OSM-R, as well as the main inflammatory cytokines and their receptors (LIFR, Gp130, IL-31, IL6, IL-1β, TNF-α, IL-4, IL-10, IL-34, CXCL8, CXCL2, IL-17 and GCSF) will be compared between tumor and non-tumor biopsy samples.
These comparisons will also be stratified by disease stage (localized, locally advanced, metastatic).
Cytokine expression will be studied by RT-qPCR after RNA extraction and retro-transcription on frozen tissue biopsies (tumor and non-tumor) in nitrogen, and the value will be expressed in relation to the expression of two common housekeeping genes, GADPH and Actin B.
Measured: 1 month
Secondary outcomes (8)
Analysis of the tumor immune cell microenvironment that secret OSM in head and neck squamous cell carcinoma with the cell-selectine RNA sequencing method.
To know what type of cells secrete OSM in the microenvironment, we will use GeoMx Nanostring (c) technique. It consists of a selective RNA or protein sequecing of immunofluorescence labelled cells on parrafine embedded tissues. Investigators will then label OSM-secreting cells with anti-OSM fluorochrome and collect it to be sequenced
Measured: 1 month
Relative expression by RT-qPCR of epithelial-mesenchymal transition (EMT) transcripts will be compared in tumoral mucosa versus normal mucosa of patients
Investigators will study the following genes : SNAI1, SERPIN B3, TGM2, ZEB1, YAP-1, FAT-1, CK13, VIM, OCT-4, SOX-2, CD-44, BMI-1 and KLF-4
Measured: 1 month
Correlation between relative expression of OSM and OSM-R by RT-qPCR and the relative expression of epithelial-mesenchymal transition transcripts in tumoral mucosa
Investigators will study the following genes : SNAI1, SERPIN B3, TGM2, ZEB1, YAP-1, FAT-1, CK13, VIM, OCT-4, SOX-2, CD-44, BMI-1 and KLF-4
Measured: 1 month
Caracterisation of the prognostic impact of tissue-level immunohistochemistry expression of OSM and OSM-R at diagnosis on progression-free survival.
Tissues will be classified as OSM positive (positive staining) or negative (no staining) and OSM-R positive or negative. Progression-free survival of positive and negative patients will be compared.
PFS will be defined as a composite criterion :progression of the mesurable target > 20%, progression > 20% AND at least 5mm and emergence of new lesions PFS will be mesured at 12 and 18 months
Measured: 18 month
Caracterisation of the prognostic impact of transcriptomic expression of OSM and OSM-R at diagnosis on progression-free survival.
Biopsies will be classified as OSM / OSM-R overexpressing tissue (ratio : relative expression of OSM and OSM-R in tumoral mucosa / relative expression of OSM and OSM-R in normal mucosa by RT-qPCR is above the median) or underexpressing tissue (ratio under the median).
Progression-free survival of overexpressing and underexpressing patients will be compared.
PFS will be defined as a composite criterion :progression of the mesurable target > 20%, progression > 20% AND at least 5mm and emergence of new lesions PFS will be mesured at 12 and 18 months
Measured: 18 month
Correlation between serum concentrations of OSM and several circulating inflammatory cytokines and their respective expression in tumor tissue in head and neck squamous cell carcinoma at diagnosis.
OSM and other cytokines (LIFR, le Gp130, l'IL-31, l'IL6, l'IL-1β, le TNF-α, l'IL-4, l'IL-10, l'IL-34, le CXCL8, le CXCL2, l'IL-17 et le GCSF) will be analysed by the semi-quantitative ELISA technique on patients's sera.
Same cytokines will be assessed in tumoral mucosa by RT-qPCR. Comparison between their relative expression by RT-qPCR and their serum concentration will be study
Measured: 1 month
Caracterisation of the prognostic impact of serum OSM concentrations at diagnosis on progression-free survival
Patients will be classified as high serum concentration of OSM at baseline or low serum concentration at baseline (concentration cut-off not known in literature) using the semi-quantitative ELISA technique.
Progression-free survival of overexpressing and underexpressing patients will be compared.
PFS will be defined as a composite criterion :progression of the mesurable target > 20%, progression > 20% AND at least 5mm and emergence of new lesions PFS will be mesured at 12 and 18 months
Measured: 1 month
Caracterisation of the relationship between changes in serum cytokine concentrations (between the time of diagnosis and 3 months after the end of initial treatment) and early response to treatment (3 months after the end of initial treatment).
For each cytokines dosed in serum, we will describe if the variation of their concentrations (R= T0 - (T0+Dt/T0))*100 ) as an impact on the response at 3 month (defined as the V2 visit).
Reponse rate is defined as (RECIST v1.1) :
complete response : no residual disease is clinically or radiologically assessable at 3 month partial response : decrease of the mesurable targets of more than 30% but still assessable stable disease : modification of the mesurable targets between a decrease of less than 30% and a progression of less than 20% progression : progression of the mesurable targets of more than 20%
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study startFeb 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199947
- Sponsor's protocol ID
- ROMCOR
- Status last verified
- Jan 2024
- First submitted
- 14 Nov 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Role of Oncostatin M in Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06199947
- Acronym / sponsor ID
- ROMCOR
- Conditions
- Head and Neck Cancer, Cytokine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Jan 2024 (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.
The ROMCOR study will be interested in the impact and the role of oncostatin M (OSM), a cytokine belonging to IL-6 superfamily, in the physiopathology of head and neck squamous cell carcinoma. The study team will study the impact of the presence of OSM and its main receptor OSM-R2 on several survival outcomes (overall survival, progression free survival) by multiple technics such as immunohistochemistry, transcriptomic in situ assays and spatial transcriptomic. Furthermore, the study team will try to show a link between serum level of several cytokines and in situ tumoral OSM.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Samples | Experimental | Other: Biopsies and Blood collection |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- over 18 years of age;
- with suspected squamous cell carcinoma of the oral cavity, oropharynx or pharyngolarynx (any stage);
- with healthy, untreated contralateral mucosa and no contraindications to biopsy;
- with no history of any type of cancer;
- with a WHO performance status index of 0 to 2 inclusive ;
Key exclusion criteria (5 listed)
- previously pre-treated in the ear, nose, throat sphere by radiotherapy or having already received anti-cancer chemotherapy;
- on long-term immunosuppressive therapy, defined as taking an immunosuppresseur, identified as such in the ATC classification, for 7 days, cortico-therapy > 7.5mg/day for more than 3 months, treatment or history of anti-CD20 treatment within the year, or regular plasmatic exchange or gamma globulin infusion;
- benefiting from enhanced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection;
- pregnant or breast-feeding women of childbearing age (menopause must be documented and more than 2 years old) who refuse or do not have an effective method of contraception (hormonal/mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy) for the duration of the study.
- final diagnosis of non-squamous cell carcinoma
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 |
|---|---|---|
| Biopsies and Blood collectionEach participant will have 2 additionnal biopsies during his/her diagnostic endoscopy plus two blood test during his/her inclusion | Other | Samples |
Primary outcome
To analyze the relative expression of OSM, several inflammatory cytokines and their receptors in head and neck squamous cell carcinomas (SCC).
Time frame: 1 month
The relative expression of transcripts for OSM, OSM-R, as well as the main inflammatory cytokines and their receptors (LIFR, Gp130, IL-31, IL6, IL-1β, TNF-α, IL-4, IL-10, IL-34, CXCL8, CXCL2, IL-17 and GCSF) will be compared between tumor and non-tumor biopsy samples. These comparisons will also be stratified by disease stage (localized, locally advanced, metastatic). Cytokine expression will be studied by RT-qPCR after RNA extraction and retro-transcription on frozen tissue biopsies (tumor and non-tumor) in nitrogen, and the value will be expressed in relation to the expression of two common housekeeping genes, GADPH and Actin B.
8 secondary outcomes
Analysis of the tumor immune cell microenvironment that secret OSM in head and neck squamous cell carcinoma with the cell-selectine RNA sequencing method.
Time frame: 1 month
Relative expression by RT-qPCR of epithelial-mesenchymal transition (EMT) transcripts will be compared in tumoral mucosa versus normal mucosa of patients
Time frame: 1 month
Correlation between relative expression of OSM and OSM-R by RT-qPCR and the relative expression of epithelial-mesenchymal transition transcripts in tumoral mucosa
Time frame: 1 month
Caracterisation of the prognostic impact of tissue-level immunohistochemistry expression of OSM and OSM-R at diagnosis on progression-free survival.
Time frame: 18 month
Caracterisation of the prognostic impact of transcriptomic expression of OSM and OSM-R at diagnosis on progression-free survival.
Time frame: 18 month
Correlation between serum concentrations of OSM and several circulating inflammatory cytokines and their respective expression in tumor tissue in head and neck squamous cell carcinoma at diagnosis.
Time frame: 1 month
Caracterisation of the prognostic impact of serum OSM concentrations at diagnosis on progression-free survival
Time frame: 1 month
Caracterisation of the relationship between changes in serum cytokine concentrations (between the time of diagnosis and 3 months after the end of initial treatment) and early response to treatment (3 months after the end of initial treatment).
Time frame: 18 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsies and Blood collection in people with Head and Neck Cancer and Cytokine, run by Poitiers University Hospital.
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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BAINAUD MATTHIEU, Dr (+33549444125, matthieu.bainaud@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To analyze the relative expression of OSM, several inflammatory cytokines and their receptors in head and neck squamous cell carcinomas (SCC). (time frame: 1 month). 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 10 Jan 2024.