Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2025-12-24 @ 9:31 PM
NCT ID:
NCT04452032
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years old
2. ECOG performance status ≤2
3. Female and Male
4. Newly diagnosed, histologically or cytologically confirmed head and neck squamous cell carcinoma (oropharynx, oral cavity, larynx, hypopharynx or cavum)
5. Results of previous pre-treatment imaging (PET-CT and cervicofacial MRI and/or CT/scan)
6. Eligible for treatment based on (chemo-)radiotherapy (with or without a surgical treatment)
7. Agree to wear, three times per week, fluoride dental splint after RT
8. HPV/p 16 testing results available at the time of screening (only for subjects with oropharynx cancer)
9. Serum pregnancy test (for subjects of childbearing potential) negative within 7 days prior to the 1st radiotherapy treatment
10. Women of childbearing potential must agree to use of one effective method of contraception prior study entry and during the course of the study.
11. Completion of all necessary screening procedures within 30 days prior to 1st radiotherapy treatment.
12. Signed Informed Consent form (ICF) obtained prior to any study related procedure.
13. Ability to understand and complete the questionnaires (language proficiency, cognitive functioning) as judged by the principal investigator upon screening
Note: Subject from the SwallPEG trial can participate in the StomRay study if they meet all of the previous eligibility criteria.
Exclusion Criteria:
1. Subject having less than ten teeth on dental arch
2. Life expectancy less than 12 months
3. History of previous head and neck irradiation
4. Prior or current treatment with bisphosphonates or denosumab
5. Presence of too many metal artefacts on the RT simulation scan preventing precise teeth contouring
6. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.
7. Pregnancy and/or lactating women
8. Subjects with imperfect amelogenesis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04452032
Study Brief:
Protocol Section:
NCT04452032