NCT02881918

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
154

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

March 14, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

4 years

First QC Date

August 19, 2016

Last Update Submit

January 24, 2018

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Presence or absence of spontaneous responses against tumor-associated antigens (TAA) according to tumor stage

    day 0

Secondary Outcomes (5)

  • Functional signature of T cell responses (polyfunctionality index of lymphocytes) according to tumor stage

    day 0

  • Number of CTCs according to tumor stage

    day 0

  • Polyfunctionality index of lymphocytes according to number of CTCs

    day 0

  • Disease free survival (survival without local or distant recurrence) according to Presence pr absence of CTCs at diagnosis

    2 years after diagnosis

  • Disease free survival (survival without local or distant recurrence) according to Presence or absence of spontaneous responses against TAA

    2 years after diagnosis

Study Arms (1)

squamous cell carcinoma

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

Other: Blood sample

Interventions

Blood sampleOTHER

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

squamous cell carcinoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • History of neoplasia, synchronous cancer, auto-immune disease, organ transplantation, chemotherapy
  • HIV infection
  • Corticotherapy during 15 days before blood sampling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Service d'ORL - CHRU BESANCON

Besançon, France

RECRUITING

Service d'ORL - CHRU DIJON

Dijon, France

NOT YET RECRUITING

Service d'ORL - CHRU REIMS

Reims, France

NOT YET RECRUITING

Service d'ORL - CHRU STRASBOURG

Strasbourg, France

RECRUITING

Institut de Cancérologie Alexis Vautrin

Vandœuvre-lès-Nancy, France

RECRUITING

Service ORL - Institut Louis Mathieu - CHRU NANCY

Vandœuvre-lès-Nancy, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Patrice GALLET

    Service de ORL, Institut Louis Mathieu, CHRU de Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrice GALLET

CONTACT

03 83 15 54 17patrice.gallet@yahoo.fr

Marcelo DE CARVALHO

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2016

First Posted

August 29, 2016

Study Start

March 14, 2017

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

January 26, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)