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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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)
Exclusion criteria
. 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