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

NCT03276819 | Terminated

• 1 other identifier: IHNPACT Umbrella
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 10

Brief 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)

Keywords

Oral potentially malignant lesions (OPML); Head and neck squamous cell carcinoma (HNSCC); Biomarkers; Smoking cessation program; Loss of heterozigoty (LOH); Medico-economics; Sociology; Psychology

Outcome Measures

Primary Outcomes (1)

• Biomarkers

  Prevalence of LOH and/or other candidate biomarkers in OPML and normal mucosa : study of their spatial and temporal dynamic changes and explore their association with the risk of developing oral cavity squamous cell carcinoma, recurrent disease or second primary tumor (blood samples, buccal biopsies, buccal cells)

  Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 from inclusion

Secondary Outcomes (11)

• alcohol quit

  Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 from inclusion

• smoking quit

  Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 from inclusion

• cannabis quit

  Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 from inclusion

• Preclinical models of oral mucosa

  Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 from inclusion

• Preclinical models of OPML

  Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 from inclusion

Other Outcomes (5)

• Cost of the cessation program

  Month 12 (M12) after randomization

• Correlation between LOH status and smoking cessation

  Month 6 and month 12 (M6, M12) after randomization

• Prevalence of a panel of constitutional genomic variants in genes known to be associated with nicotine dependance

  Day 0 (at randomization)

Study Arms (3)

Cohort A

EXPERIMENTAL

Samples collection and Tobacco and alcohol status follow-up for patient with OPML: Follow-up of the lesions (pictures, biopsies, brushes), malignant transformation oversight, smoking and alcohol status follow-up (questionnaires), blood and saliva samples

Procedure: Samples collection; Behavioral: Tobacco and alcohol status follow-up

Cohort B

EXPERIMENTAL

Samples collection; Psychological and Sociological evaluation; Intensive and sustained smoking cessation program; Tobacco and alcohol status follow-up for patient with resectable HNSCC requiring postoperative radiotherapy or chemoradiation and which are either current smokers motivated to quit or reformed smokers within 3 months before the diagnosis of a resectable HNSCC. Randomization 1:1, arm 1 = minimal tobacco cessation intervention, arm 2 = intensive and sustained smoking cessation program. Smoking and alcohol status follow-up, adhesion to the smoking cessation program, tumoral follow-up, second malignant lesion, tumoral collection, blood biomarkers research

Procedure: Samples collection; Behavioral: Psychological and Sociological evaluation; Behavioral: Intensive and sustained smoking cessation program; Behavioral: Tobacco and alcohol status follow-up

Cohort C

EXPERIMENTAL

Samples collection and Tobacco and alcohol status follow-up for patients with resectable HNSCC wich are not eligible to cohort B Smoking and alcohol status follow-up (questionnaires), tumoral follow-up, second malignant lesion and OPML lesion appearance oversight, tumoral collection, blood biomarkers research

Procedure: Samples collection; Behavioral: Tobacco and alcohol status follow-up

Interventions

Samples collection PROCEDURE

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

Cohort A; Cohort B; Cohort C

Psychological and Sociological evaluation BEHAVIORAL

Cohort B ....

Cohort B

Intensive and sustained smoking cessation program BEHAVIORAL

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

Cohort B

Tobacco and alcohol status follow-up BEHAVIORAL

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

Cohort A; Cohort B; Cohort C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years at the day of consenting to the study (or at the day of randomization for cohort B patients not included in the global study)
• Patients with OPML: at least one lesion ≥ 5 mm (Cohort A only)
• Patients with surgically resectable HNSCC not treated with preoperative chemotherapy, pT1-4 N0-3 M0 (Cohort B only)
• Patients with surgically resectable HNSCC not treated with preoperative chemotherapy and non-eligible to cohort B (Cohort C only)
• PS ECOG ≤ 1
• Treatment plan incorporating surgery and radiation therapy (or at the day of randomization for cohort B patients not included in the global study)
• Smoker = Adult who have smoked at least 100 cigarettes in his/her lifetime (Cohort B only)
• Current smoker (who currently smokes cigarettes every day (daily) or some days (nondaily)) or former smoker (who says he/she doesn't smoke) who stops smoking within 3 months prior to diagnosis (Cohort B only)
• Motivation to quit smoking evaluated by the Richmond test (Cohort B only)
• Without subordination motivation to quit smoking (Cohort B only)
• Covered by a medical insurance
• Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrolment

You may not qualify if:

• Non-stabilized cognitive disorder
• Synchronous malignancy (Cohort A only)
• History of malignant disease outside the upper aerodigestive tract, except skin carcinoma
• Substance use disorder other than smoking (cigarette and cannabis) and alcohol (Cohort B only)
• Use of nicotine replacement therapy, bupropion, varenicline on last 3 months (Cohort B only)
• Undergoing on last 3 months' behavioral and cognitive therapy for smoking cessation (Cohort B only)
• Patient included in a clinical trial evaluating interventions for smoking cessation (Cohort B only)
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• Pregnant or breastfeeding woman

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (10)

Centre Hospitalier Annecy genevois

Annecy, 74374, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

CHU de Grenoble

Grenoble, 38043, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

CHU de Montpellier, Hôpital Gui De Chauliac

Montpellier, 34295, France

Location

AP-HP, Hôpital de la Pitié Salpêtrière

Paris, 75013, France

Location

Hospices Civils de Lyon, Hôpital Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU de Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (1)

• Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.

  PMID: 33605440 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Tobacco Products; Ethanol

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Alcohols; Organic Chemicals

Study Officials

• Pierre SAINTIGNY, Dr

  Centre Léon Bérard, Lyon, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cohort A : Patients with OPML Cohort B : Patients with resectable HNSCC requiring postoperative radiotherapy or chemoradiation and which are either current smokers motivated to quit or reformed smokers within 3 months before the diagnosis of a resectable HNSCC Cohort C : Patients with resectable HNSCC wich are not eligible to cohort B

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 8, 2017
• Study Start: February 1, 2018
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

FR (10)