Anti-tumor Specific Immune Response in Head and Neck Cancers

Head and Neck Squamous Cell Carcinoma Clinical Trial

— CORISAT  

Official title:

Anti-tumor Specific Immune Response in Head and Neck Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02881918
• Other study ID #: PSS2016 / CORISAT-GALLET/SR
• Status: Recruiting
• Phase: N/A
• First received: August 19, 2016
• Last updated: January 24, 2018
• Start date: March 14, 2017
• Est. completion date: March 2021

Study information

• Verified date: January 2018
• Source: Central Hospital, Nancy, France
• Contact: Patrice GALLET
• Phone: 03 83 15 54 17
• Email: patrice.gallet[@]yahoo.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma

Intervention

Other:
• Blood sample
Blood sample with 6 tube of blood (40 mL), after diagnosis and before any specific anticancer treatment

Locations

Country	Name	City	State
France	Service d'ORL - CHRU BESANCON	Besancon
France	Service d'ORL - CHRU DIJON	Dijon
France	Service d'ORL - CHRU REIMS	Reims
France	Service d'ORL - CHRU STRASBOURG	Strasbourg
France	Institut de Cancérologie Alexis Vautrin	Vandoeuvre les Nancy
France	Service ORL - Institut Louis Mathieu - CHRU NANCY	Vandoeuvre les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of spontaneous responses against tumor-associated antigens (TAA) according to tumor stage		day 0
Secondary	Functional signature of T cell responses (polyfunctionality index of lymphocytes) according to tumor stage	Effector functions and phenotypes of T cells	day 0
Secondary	Number of CTCs according to tumor stage		day 0
Secondary	Polyfunctionality index of lymphocytes according to number of CTCs		day 0
Secondary	Disease free survival (survival without local or distant recurrence) according to Presence pr absence of CTCs at diagnosis		2 years after diagnosis
Secondary	Disease free survival (survival without local or distant recurrence) according to Presence or absence of spontaneous responses against TAA		2 years after diagnosis