Clinical trial · Interventional
A Clinical and Biological Umbrella Protocol for Smoker or Non-smoker Patients With OPML or HNSCC
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Early termination of the study, since July 31, 2020 for insufficient recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma (HNSCC) | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Premalignant Lesion | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensive and sustained smoking cessation program | Behavioral | — | UNRESOLVED |
| Psychological and Sociological evaluation | Behavioral | — | UNRESOLVED |
| Samples collection | Procedure | — | UNRESOLVED |
| Tobacco and alcohol status follow-up | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort A
- description
- Samples collection and Tobacco and alcohol status follow-up for patient with OPML: Follow-up of the lesions (pictures, biopsies, brushes), malignant transformation oversight, smoking and alcohol status follow-up (questionnaires), blood and saliva samples
- interventionNames
- Procedure: Samples collection
- Behavioral: Tobacco and alcohol status follow-up
- type
- EXPERIMENTAL
- label
- Cohort B
- description
- Samples collection; Psychological and Sociological evaluation; Intensive and sustained smoking cessation program; Tobacco and alcohol status follow-up for patient with resectable HNSCC requiring postoperative radiotherapy or chemoradiation and which are either current smokers motivated to quit or reformed smokers within 3 months before the diagnosis of a resectable HNSCC. Randomization 1:1, arm 1 = minimal tobacco cessation intervention, arm 2 = intensive and sustained smoking cessation program. Smoking and alcohol status follow-up, adhesion to the smoking cessation program, tumoral follow-up, second malignant lesion, tumoral collection, blood biomarkers research
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHolliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4. PMID 33605440