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A Clinical and Biological Umbrella Protocol for Smoker or Non-smoker Patients With OPML or HNSCC

NCT03276819 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2020-10-08

No results posted yet for this study

Summary

This is a multicenter minimal risk or burden prospective 3-cohort follow-up and monitoring study that aims to collect clinical, socio-psychological, medico-economics data and biospecimens for patients with oral potentially malignant lesions (OPML) or resectable head and neck squamous cell carcinoma (HNSCC) :

* Cohort A: OPML patients.
* Cohort B (specific design): smokers (adults who have smoked at least 100 cigarettes in their lifetime) motivated to quit - either current smokers (who currently smokes cigarettes every day (daily) or some days (nondaily)) or former smokers (adults who have smoked at least 100 cigarettes in their lifetime, but say they currently do not smoke) who stops smoking within 3 months prior to the diagnosis - with a resectable HNSCC requiring postoperative radiotherapy or chemoradiation.
* Cohort C: Patients with resectable HNSCC non-eligible to cohort B.

The primary objective of this study is the identification of biomarkers (predictive of malignant transformation or second primary tumor) and new strategies for prevention and therapy, mainly through extensive genomic, epigenomic and immune characterization of OPML and HNSCC.

Conditions

  • Premalignant Lesion
  • Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions

PROCEDURE

Samples collection

OPML biopsy or resection, biopsy of normal oral mucosa, surgical specimen of HNSCC, saliva samples, buccal brushes, blood samples

BEHAVIORAL

Psychological and Sociological evaluation

Cohort B ....

BEHAVIORAL

Intensive and sustained smoking cessation program

Evaluation of efficacy of the smoking cessation program (intensive and sustained versus minimal)

BEHAVIORAL

Tobacco and alcohol status follow-up

Evaluation of the tobacco and alcohol status all along the study (questionnaires)

Sponsors & Collaborators

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • Pierre SAINTIGNY, Dr · Centre Léon Bérard, Lyon, France

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03276819 on ClinicalTrials.gov