NCT03139058

Brief Summary

Tobacco and alcohol are the two major risk factors for upper respiratory tract cancer (VADS).

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

April 27, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
1.3 years until next milestone

Study Start

First participant enrolled

August 20, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

10 months

First QC Date

April 27, 2017

Last Update Submit

August 20, 2018

Conditions

Liver FibrosesLiver CirrhosesSquamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (1)

  • Determine the prevalence, by registry data analysis, of cirrhosis in patients with VADS cancer

    Determine the prevalence, by registry data analysis, of cirrhosis in patients with VADS cancer

    1 day

Study Arms (1)

prevalence of cirrhosis

OTHER

Study the prevalence of cirrhosis in patients with VADS cancer

Other: Evaluation of the hepatic fibrosis

Interventions

Evaluation of the hepatic fibrosisOTHER

Evaluation of the hepatic fibrosis stage by a hepatological assessment (Clinical, biological and imaging)

prevalence of cirrhosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient over 18 years of age
  • Supported in the department of Orl \& CCF or Maxillo-Faciale surgery of the CHU d'Amiens
  • Histological diagnosis of epidermoid carcinoma:
  • From the oral cavity
  • From the oropharynx
  • Hypopharynx
  • Larynx
  • Any stage of cancer
  • Affiliation to a social security scheme

You may not qualify if:

  • Patient already treated previously for a cancer of the VADS
  • Patient referred to in Articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Liver CirrhosisSquamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • Cyril PAGE, PhD

    CHU AMIENS PICARDIE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cyril PAGE, PhD

CONTACT

+33322668623page.cyril@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2017

First Posted

May 3, 2017

Study Start

August 20, 2018

Primary Completion

June 20, 2019

Study Completion

June 20, 2019

Last Updated

August 21, 2018

Record last verified: 2018-08

Locations

FR(1)