Clinical trial NCT02881918: Anti-tumor Specific Immune Response in Head and Neck Cancers
Official title: Anti-tumor Specific Immune Response in Head and Neck Cancers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Squamous Cell Carcinoma
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-29
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Head \& Neck Squamous Cell Carcinoma before any medical or surgical treatment specifically directed against cancer

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* History of neoplasia, synchronous cancer, auto-immune disease, organ transplantation, chemotherapy
* HIV infection
* Corticotherapy during 15 days before blood sampling

Primary outcomes:
measure: Presence or absence of spontaneous responses against tumor-associated antigens (TAA) according to tumor stage
timeFrame: day 0
Secondary outcomes:
measure: Functional signature of T cell responses (polyfunctionality index of lymphocytes) according to tumor stage
timeFrame: day 0
measure: Number of CTCs according to tumor stage
timeFrame: day 0
measure: Polyfunctionality index of lymphocytes according to number of CTCs
timeFrame: day 0
measure: Disease free survival (survival without local or distant recurrence) according to Presence pr absence of CTCs at diagnosis
timeFrame: 2 years after diagnosis
measure: Disease free survival (survival without local or distant recurrence) according to Presence or absence of spontaneous responses against TAA
timeFrame: 2 years after diagnosis
Other outcomes:
Locations:
city: Besancon
country: France
facility: Service d'ORL - CHRU BESANCON
city: Dijon
country: France
facility: Service d'ORL - CHRU DIJON
city: Reims
country: France
facility: Service d'ORL - CHRU REIMS
city: Strasbourg
country: France
facility: Service d'ORL - CHRU STRASBOURG
city: Vandoeuvre les Nancy
country: France
facility: Institut de Cancérologie Alexis Vautrin
city: Vandoeuvre les Nancy
country: France
facility: Service ORL - Institut Louis Mathieu - CHRU NANCY
Study officials:
affiliation: Service de ORL, Institut Louis Mathieu, CHRU de Nancy
name: Patrice GALLET
role: PRINCIPAL_INVESTIGATOR
References: