Anti-tumor Specific Immune Response in Head and Neck Cancers

NCT ID: NCT02881918

Last Updated: 2018-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

154 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-14

Study Completion Date

2021-03-31

Brief Summary

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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

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Conditions

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Head and Neck Squamous Cell Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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squamous cell carcinoma

Patients affected by Head \& Neck Squamous Cell Carcinoma. Blood sample at diagnosis, before any antitumor treatment

Blood sample

Intervention Type OTHER

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

Interventions

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Blood sample

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrice GALLET

Role: PRINCIPAL_INVESTIGATOR

Service de ORL, Institut Louis Mathieu, CHRU de Nancy

Locations

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Service d'ORL - CHRU BESANCON

Besançon, , France

Site Status RECRUITING

Service d'ORL - CHRU DIJON

Dijon, , France

Site Status NOT_YET_RECRUITING

Service d'ORL - CHRU REIMS

Reims, , France

Site Status NOT_YET_RECRUITING

Service d'ORL - CHRU STRASBOURG

Strasbourg, , France

Site Status RECRUITING

Institut de Cancérologie Alexis Vautrin

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Service ORL - Institut Louis Mathieu - CHRU NANCY

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrice GALLET

Role: CONTACT

03 83 15 54 17 ext. +33

Marcelo DE CARVALHO

Role: CONTACT

Facility Contacts

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Olivier MAUVAIS

Role: primary

Philippe SCHULTZ

Role: primary

Gilles DOLIVET

Role: primary

Patrice GALLET

Role: primary

Other Identifiers

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PSS2016 / CORISAT-GALLET/SR

Identifier Type: -

Identifier Source: org_study_id

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