Anti-tumor Specific Immune Response in Head and Neck Cancers | NCT02881918

Studies
Anti-tumor Specific Immune Response in Head and Neck Cancers

NCT02881918

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Jan 26, 2018Actual

Enrollment

154Estimated

Phase

Not provided

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

Blood sample

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 14, 2017Actual

Primary Completion Date

Mar 2021Estimated

Completion Date

Mar 2021Estimated

First Submitted Date

Aug 19, 2016

First Submission Date that Met QC Criteria

Aug 24, 2016

First Posted Date

Aug 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2018

Last Update Posted Date

Jan 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

154Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
squamous cell carcinoma		Patients affected by Head & Neck Squamous Cell Carcinoma. Blood sample at diagnosis, before any antitumor treatment	Other: Blood sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sample	Other	Blood sample with 6 tube of blood (40 mL), after diagnosis and before any specific anticancer treatment	squamous cell carcinoma

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Functional signature of T cell responses (polyfunctionality index of lymphocytes) according to tumor stage	Effector functions and phenotypes of T cells	day 0
Number of CTCs according to tumor stage

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with Head & Neck Squamous Cell Carcinoma before any medical or surgical treatment specifically directed against cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patrice GALLET	Contact	03 83 15 54 17	+33	patrice.gallet@yahoo.fr
Marcelo DE CARVALHO	Contact

Overall Officials

Name	Affiliation	Role
Patrice GALLET	Service de ORL, Institut Louis Mathieu, CHRU de Nancy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'ORL - CHRU BESANCON	Recruiting	Besançon			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000077195	Squamous Cell Carcinoma of Head and Neck

Ancestor Terms

ID	Term
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided