Head and Neck Squamous Cell CarcinomaCORISATNCT02881918
Anti-tumor Specific Immune Response in Head and Neck Cancers
An observational study of Head and Neck Squamous Cell Carcinoma, run by Central Hospital, Nancy, France at 6 sites in France.
Trial summary
The purpose is the description of anti-tumor immune responses in general and according to clinical stage and disease free survival (DFS: survival without recurrence (local or distant)) in patients with Head \& Neck Squamous Cell Carcinoma Secondary purposes are: Study of relationship between anti-tumor immune response… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Blood sample
- How many people
- 154 participants
- Where
- 6 sitesFrance
- Study dates
- 14 Mar 2017to Mar 2021
- 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: Patients with Head \& Neck Squamous Cell Carcinoma before any medical or surgical treatment specifically directed against cancer
Who may be able to join
- Patient with Head \& Neck Squamous Cell Carcinoma after extension assessment, regardless of clinical stage (TNM UICC stage I-IV), before any medical or surgical treatment specifically directed against cancer (radiotherapy, surgery, chemotherapy or targeted therapy)
- Consent to participate to the study, non-opposition
- Affiliation to social security
Who cannot join
- History of neoplasia, synchronous cancer, auto-immune disease, organ transplantation, chemotherapy
- HIV infection
- Corticotherapy during 15 days before blood sampling
Trial locations and contacts
6 sites in 1 country.
Marcelo DE CARVALHO contact
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Service d'ORL - CHRU BESANCON
Besançon
Olivier MAUVAIS
- Not yet recruiting
Service d'ORL - CHRU DIJON
Dijon
- Not yet recruiting
Service d'ORL - CHRU REIMS
Reims
- Recruiting
Service d'ORL - CHRU STRASBOURG
Strasbourg
Philippe SCHULTZ
- Recruiting
Institut de Cancérologie Alexis Vautrin
Vandœuvre-lès-Nancy
Gilles DOLIVET
- Recruiting
Service ORL - Institut Louis Mathieu - CHRU NANCY
Vandœuvre-lès-Nancy
Patrice GALLET
About this study
The purpose is the description of anti-tumor immune responses in general and according to clinical stage and disease free survival (DFS: survival without recurrence (local or distant)) in patients with Head \& Neck Squamous Cell Carcinoma
Secondary purposes are:
- Study of relationship between anti-tumor immune response and qualitative (yes/no) and quantitative (number) presence of circulating tumor cells (CTCs);
- Study of relationship between qualitative (yes/no) and quantitative (number) presence of CTCs and clinical stage as well as DFS
- Study of relationship between anti-tumor immune response and clinical stage as well as DFS.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Blood sample
- Medical subject headings
- 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.
Blood sampleOther
Blood sample with 6 tube of blood (40 mL), after diagnosis and before any specific anticancer treatment
| Study group | Role | What they receive |
|---|---|---|
| squamous cell carcinoma | Patients affected by Head \& Neck Squamous Cell Carcinoma. Blood sample at diagnosis, before any antitumor treatment Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of spontaneous responses against tumor-associated antigens (TAA) according to tumor stage
Measured: day 0
Secondary outcomes (5)
Functional signature of T cell responses (polyfunctionality index of lymphocytes) according to tumor stage
Effector functions and phenotypes of T cells
Measured: day 0
Number of CTCs according to tumor stage
Measured: day 0
Polyfunctionality index of lymphocytes according to number of CTCs
Measured: day 0
Disease free survival (survival without local or distant recurrence) according to Presence pr absence of CTCs at diagnosis
Measured: 2 years after diagnosis
Disease free survival (survival without local or distant recurrence) according to Presence or absence of spontaneous responses against TAA
Measured: 2 years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study start14 Mar 2017
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (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 Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrice GALLET, Principal investigator, Service de ORL, Institut Louis Mathieu, CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881918
- Sponsor's protocol ID
- PSS2016 / CORISAT-GALLET/SR
- Acronym
- CORISAT
- Status last verified
- Jan 2018
- First submitted
- 19 Aug 2016
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-tumor Specific Immune Response in Head and Neck Cancers
- ClinicalTrials.gov ID
- NCT02881918
- Acronym / sponsor ID
- CORISAT / PSS2016 / CORISAT-GALLET/SR
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 29 Aug 2016 (estimated)
- 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 purpose is the description of anti-tumor immune responses in general and according to clinical stage and disease free survival (DFS: survival without recurrence (local or distant)) in patients with Head \& Neck Squamous Cell Carcinoma
Secondary purposes are:
- Study of relationship between anti-tumor immune response and qualitative (yes/no) and quantitative (number) presence of circulating tumor cells (CTCs);
- Study of relationship between qualitative (yes/no) and quantitative (number) presence of CTCs and clinical stage as well as DFS
- Study of relationship between anti-tumor immune response and clinical stage as well as DFS.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| squamous cell carcinoma | – | Other: Blood samplePatients affected by Head \& Neck Squamous Cell Carcinoma. Blood sample at diagnosis, before any antitumor treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Head \& Neck Squamous Cell Carcinoma before any medical or surgical treatment specifically directed against cancer
Key inclusion criteria (3 listed)
- Patient with Head \& Neck Squamous Cell Carcinoma after extension assessment, regardless of clinical stage (TNM UICC stage I-IV), before any medical or surgical treatment specifically directed against cancer (radiotherapy, surgery, chemotherapy or targeted therapy)
- Consent to participate to the study, non-opposition
- Affiliation to social security
Key exclusion criteria (3 listed)
- History of neoplasia, synchronous cancer, auto-immune disease, organ transplantation, chemotherapy
- HIV infection
- Corticotherapy during 15 days before blood sampling
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 |
|---|---|---|
| Blood sampleBlood sample with 6 tube of blood (40 mL), after diagnosis and before any specific anticancer treatment | Other | squamous cell carcinoma |
Primary outcome
Presence or absence of spontaneous responses against tumor-associated antigens (TAA) according to tumor stage
Time frame: day 0
5 secondary outcomes
Functional signature of T cell responses (polyfunctionality index of lymphocytes) according to tumor stage
Time frame: day 0
Number of CTCs according to tumor stage
Time frame: day 0
Polyfunctionality index of lymphocytes according to number of CTCs
Time frame: day 0
Disease free survival (survival without local or distant recurrence) according to Presence pr absence of CTCs at diagnosis
Time frame: 2 years after diagnosis
Disease free survival (survival without local or distant recurrence) according to Presence or absence of spontaneous responses against TAA
Time frame: 2 years after diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruiting
Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
Squamous Cell Cancer of Head and Neck (SCCHN)
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.
Marcelo DE CARVALHO contact
Patrice GALLET principal investigator
Service de ORL, Institut Louis Mathieu, CHRU de Nancy
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Squamous Cell Carcinoma, run by Central Hospital, Nancy, France at 6 sites 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 3 inclusion and 3 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 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrice GALLET (03 83 15 54 17 ext. +33, patrice.gallet@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of spontaneous responses against tumor-associated antigens (TAA) according to tumor stage (time frame: day 0). 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 26 Jan 2018.