Anti-tumor Specific Immune Response in Head and Neck Cancers

• Conditions: Head and Neck Squamous Cell Carcinoma
• Interventions: Other: Blood sample

• Registration Number: NCT02881918
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-08-24
• Study First Posted: 2016-08-29
• Study Start: 2017-03-14
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-01-26
• Primary Completion: 2021-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 154

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
squamous cell carcinoma	Blood sample	Patients affected by Head \& Neck Squamous Cell Carcinoma. Blood sample at diagnosis, before any antitumor treatment

Primary Outcome Measures

Name	Time	Method
Presence or absence of spontaneous responses against tumor-associated antigens (TAA) according to tumor stage	day 0

Secondary Outcome Measures

Name	Time	Method
Disease free survival (survival without local or distant recurrence) according to Presence pr absence of CTCs at diagnosis	2 years after diagnosis
Functional signature of T cell responses (polyfunctionality index of lymphocytes) according to tumor stage	day 0	Effector functions and phenotypes of T cells
Number of CTCs according to tumor stage	day 0
Disease free survival (survival without local or distant recurrence) according to Presence or absence of spontaneous responses against TAA	2 years after diagnosis
Polyfunctionality index of lymphocytes according to number of CTCs	day 0

Trial Locations

Locations (6)

Service d'ORL - CHRU BESANCON; 🇫🇷 Besancon, France

Service d'ORL - CHRU DIJON; 🇫🇷 Dijon, France

Service ORL - Institut Louis Mathieu - CHRU NANCY; 🇫🇷 Vandoeuvre les Nancy, France

Service d'ORL - CHRU REIMS; 🇫🇷 Reims, France

Service d'ORL - CHRU STRASBOURG; 🇫🇷 Strasbourg, France

Institut de Cancérologie Alexis Vautrin; 🇫🇷 Vandoeuvre les Nancy, France