Head and Neck Squamous Cell Carcinoma (HNSCC) Clinical Trial
— UMBRELLAOfficial title:
A Clinical and Biological Umbrella Protocol for Smoker or Non-smoker Patients With Oral Potentially Malignant Lesions (OPML) or Head and Neck Squamous Cell Carcinoma (HNSCC) (IHNPACT UMBRELLA)
Verified date | October 2020 |
Source | Centre Leon Berard |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 53 |
Est. completion date | July 31, 2020 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. 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) 2. Patients with OPML: at least one lesion = 5 mm (Cohort A only) 3. Patients with surgically resectable HNSCC not treated with preoperative chemotherapy, pT1-4 N0-3 M0 (Cohort B only) 4. Patients with surgically resectable HNSCC not treated with preoperative chemotherapy and non-eligible to cohort B (Cohort C only) 5. PS ECOG = 1 6. Treatment plan incorporating surgery and radiation therapy (or at the day of randomization for cohort B patients not included in the global study) 7. Smoker = Adult who have smoked at least 100 cigarettes in his/her lifetime (Cohort B only) 8. 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) 9. Motivation to quit smoking evaluated by the Richmond test (Cohort B only) 10. Without subordination motivation to quit smoking (Cohort B only) 11. Covered by a medical insurance 12. Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrolment Exclusion Criteria: 1. Non-stabilized cognitive disorder 2. Synchronous malignancy (Cohort A only) 3. History of malignant disease outside the upper aerodigestive tract, except skin carcinoma 4. Substance use disorder other than smoking (cigarette and cannabis) and alcohol (Cohort B only) 5. Use of nicotine replacement therapy, bupropion, varenicline on last 3 months (Cohort B only) 6. Undergoing on last 3 months' behavioral and cognitive therapy for smoking cessation (Cohort B only) 7. Patient included in a clinical trial evaluating interventions for smoking cessation (Cohort B only) 8. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 9. Pregnant or breastfeeding woman |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Annecy genevois | Annecy | |
France | CHU de Clermont-Ferrand | Clermont-Ferrand | |
France | CHU de Grenoble | Grenoble | |
France | Centre Léon Bérard | Lyon | |
France | CHU de Montpellier, Hôpital Gui De Chauliac | Montpellier | |
France | AP-HP, Hôpital de la Pitié Salpêtrière | Paris | |
France | Hospices Civils de Lyon, Hôpital Lyon Sud | Pierre-Bénite | |
France | CHU de Nancy | Vandœuvre-lès-Nancy | |
France | Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | |
France | Institut Gustave Roussy | Villejuif |
Lead Sponsor | Collaborator |
---|---|
Centre Leon Berard |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cost of the cessation program | Cost of the cessation programs (Cohort B only): addictologist visits, nicotine replacement therapy, behaviorial and cognitive thérapies, psychological interventions... | Month 12 (M12) after randomization | |
Other | Correlation between LOH status and smoking cessation | - To analyze the LOH status at baseline (normal mucosa on resected specimen and tumor) and the dynamics of LOH changes in oral brushes (baseline, M6 and M12) to evaluate whether they may serve as a surrogate of smoking cessation (Cohort B only) | Month 6 and month 12 (M6, M12) after randomization | |
Other | Prevalence of a panel of constitutional genomic variants in genes known to be associated with nicotine dependance | Prevalence of a panel of constitutional genomic variants in genes known to be associated with nicotine dependance in patients refusing assistance for smoking cessation in comparison with patients willing to quit (Cohort B only) | Day 0 (at randomization) | |
Other | Psychological evaluation | to determine psychological characteristics of patients, with a focus on patients who refuse assistance for smoking cessation in comparison with patients willing to quit, to decipher reasons for acceptance or refusal to enter an intensive smoking cessation program and to identify patients representations for their smoking/alcohol addiction and how patients understand their level of risk and cope/react with it (Cohort B only) | Within 2 months after randomization | |
Other | Sociological evaluation | to determine sociological characteristics of patients, with a focus on patients who refuse assistance for smoking cessation in comparison with patients willing to quit, to decipher reasons for acceptance or refusal to enter an intensive smoking cessation program and to identify patients representations for their smoking/alcohol addiction and how patients understand their level of risk and cope/react with it (Cohort B only) | After randomization and Month 6 after randomization | |
Primary | 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 | alcohol quit | Evaluation of alcohol quit rates for addicted patients (cohorts A and C only) | Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 from inclusion | |
Secondary | smoking quit | Evaluation of smoking quit rates for addicted patients (cohorts A and C only) | Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 from inclusion | |
Secondary | cannabis quit | Evaluation of cannabis quit rates for addicted patients (cohorts A and C only) | Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 from inclusion | |
Secondary | Preclinical models of oral mucosa | Patient-derived preclinical models of oral normal mucosa from smokers/drinkers and non smokers/non drinkers | Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 from inclusion | |
Secondary | Preclinical models of OPML | Patient-derived preclinical models of OPML from smokers/drinkers and non smokers/non drinkers | Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 from inclusion | |
Secondary | Preclinical models of HNSCC | Patient-derived preclinical models of HNSCC from smokers/drinkers and non smokers/non drinkers | Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 from inclusion | |
Secondary | Efficacy of intensive and sustained smoking cessation program | Evaluation of the efficacy of an experimental, intensive and sustained smoking cessation program, versus minimal tobacco cessation intervention, in helping patients with HNSCC to achieve long-term abstinence (at 12 months after randomization), middle term-abstinence (at least 6 months after randomisation) or to reduce cigarette consumption by at least 50% of baseline levels (cohort B only) | Month 6, Month 12 after randomization | |
Secondary | Time to smoking resumption | Evaluation of the time to smoking resumption (i;e; delay between randomization and smoking resumption) for the patients unable to achieve abstinence in the 2 arms (cohort B only) | Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 after randomization | |
Secondary | Health-related quality of life | Evaluation of the health-related quality of life using quality of life questionnaire QLQ-C30 assessment (cohort B only) | Month 6, Month 12 after randomization | |
Secondary | Health-related quality of life | Evaluation of the health-related quality of life using quality of life questionnaire QLQ-H&N35 assessment (cohort B only) | Month 6, Month 12 after randomization | |
Secondary | Patients' preference to the 2 smoking cessation programs | Evaluation of the patients' preference by assessement of the rate of patients who refuse the intensive and sustained smoking cessation program. | Month 12 after randomization |
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