Please select the arm or intervention descriptions that belong to the clinical trial below.
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)
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.


Options:
A: Arm Label: Cohort A; Type: EXPERIMENTAL; Interventions: Procedure: Samples collection, Behavioral: Tobacco and alcohol status follow-up | Arm Label: Cohort B; Type: EXPERIMENTAL; Interventions: Procedure: Samples collection, Behavioral: Psychological and Sociological evaluation, Behavioral: Intensive and sustained smoking cessation program, Behavioral: Tobacco and alcohol status follow-up | Arm Label: Cohort C; Type: EXPERIMENTAL; Interventions: Procedure: Samples collection, Behavioral: Tobacco and alcohol status follow-up | Intervention Type: PROCEDURE; Name: Samples collection; Assigned to Arm(s): Cohort A, Cohort B, Cohort C | Intervention Type: BEHAVIORAL; Name: Psychological and Sociological evaluation; Assigned to Arm(s): Cohort B | Intervention Type: BEHAVIORAL; Name: Intensive and sustained smoking cessation program; Assigned to Arm(s): Cohort B | Intervention Type: BEHAVIORAL; Name: Tobacco and alcohol status follow-up; Assigned to Arm(s): Cohort A, Cohort B, Cohort C
B: Intervention Type: DRUG; Name: dianicline; Assigned to Arm(s): N/A
C: Arm Label: Treatment as Usual Group 1; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Treatment as Usual Group 2; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Intervention Group 1; Type: EXPERIMENTAL; Interventions: Behavioral: Computer Screening, Brief Intervention, Referral toTreatment | Arm Label: Intervention Group 2; Type: EXPERIMENTAL; Interventions: Behavioral: Computer Screening, Brief Intervention, Referral toTreatment | Intervention Type: BEHAVIORAL; Name: Computer Screening, Brief Intervention, Referral toTreatment; Assigned to Arm(s): Intervention Group 1, Intervention Group 2
D: Arm Label: varenicline; Type: EXPERIMENTAL; Interventions: Drug: varenicline | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: varenicline; Assigned to Arm(s): varenicline | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo

Answer: A