Anti-tumor Specific Immune Response in Head and Neck Cancers

Anti-tumor Specific Immune Response in Head and Neck Cancers: Condition:   Head and Neck Squamous Cell Carcinoma

Intervention:   Other: Blood sample

Sponsor:   Central Hospital, Nancy, France

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.

Condition	Intervention
Head and Neck Squamous Cell Carcinoma	Other: Blood sample

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Anti-tumor Specific Immune Response in Head and Neck Cancers

Resource links provided by NLM:

Genetics Home Reference related topics: head and neck squamous cell carcinoma

MedlinePlus related topics: Cancer Head and Neck Cancer

U.S. FDA Resources 

Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:

• Presence or absence of spontaneous responses against tumor-associated antigens (TAA) according to tumor stage [ Time Frame: day 0 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

• Functional signature of T cell responses (polyfunctionality index of lymphocytes) according to tumor stage [ Time Frame: day 0 ] [ Designated as safety issue: No ]
  Effector functions and phenotypes of T cells
• Number of CTCs according to tumor stage [ Time Frame: day 0 ] [ Designated as safety issue: No ]
• Polyfunctionality index of lymphocytes according to number of CTCs [ Time Frame: day 0 ] [ Designated as safety issue: No ]
• Disease free survival (survival without local or distant recurrence) according to Presence pr absence of CTCs at diagnosis [ Time Frame: 2 years after diagnosis ] [ Designated as safety issue: No ]
• 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood sample

Estimated Enrollment:	154
Study Start Date:	September 2016
Estimated Study Completion Date:	March 2020
Estimated Primary Completion Date:	March 2020 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
squamous cell carcinoma Patients affected by Head & Neck Squamous Cell Carcinoma. Blood sample at diagnosis, before any antitumor treatment	Other: Blood sample Blood sample with 6 tube of blood (40 mL), after diagnosis and before any specific anticancer treatment

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