A Clinical and Biological Umbrella Protocol for Smoker or Non-smoker Patients With OPML or HNSCC (NCT03276819) | Clinical Trial Compass
TerminatedNot Applicable
A Clinical and Biological Umbrella Protocol for Smoker or Non-smoker Patients With OPML or HNSCC
Stopped: Early termination of the study, since July 31, 2020 for insufficient recruitment
France53 participantsStarted 2018-02-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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)
✕. 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