Status:
TERMINATED
A Clinical and Biological Umbrella Protocol for Smoker or Non-smoker Patients With OPML or HNSCC
Lead Sponsor:
Centre Leon Berard
Conditions:
Premalignant Lesion
Head and Neck Squamous Cell Carcinoma (HNSCC)
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
The long-term goal of this study is to reduce the incidence of HNSCC which may impact as well other smoking-related cancers. It may be interesting to foster excellent translational research towards th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2020
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03276819
Start Date
February 1 2018
End Date
July 31 2020
Last Update
October 8 2020
Active Locations (10)
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1
Centre Hospitalier Annecy genevois
Annecy, France, 74374
2
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63003
3
CHU de Grenoble
Grenoble, France, 38043
4
Centre Léon Bérard
Lyon, France, 69373