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 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT07218068
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 years and older
* Willing and able to provide signed and dated consent form
* Presence of at least 4 natural erupted teeth remaining in the mouth after completion of pre-RT dental management
* Diagnosed with head and neck squamous cell carcinoma (SCC) or a salivary gland cancer (SGC), and intends to receive external beam radiation therapy (RT) with curative intent (tumor eradication), with or without concomitant chemotherapy;
OR
* Diagnosed with a non-SCC, non-SGC malignancy of the head and neck region, and intends to receive RT, with or without concomitant chemotherapy. The participant must be expected to receive at least 4500 cGy to one of the following sites:
1. base of tongue
2. buccal/labial mucosa
3. epiglottis
4. floor of mouth
5. gingiva/alveolar ridge
6. hard palate
7. hypopharynx
8. larynx
9. lip
10. mandible
11. maxilla
12. maxillary sinus
13. nasal cavity
14. nasopharynx
15. neck
16. oral cavity
17. oral tongue
18. oropharynx
19. paranasal sinus/orbit
20. parotid gland
21. pharynx
22. retromolar trigone
23. soft palate
24. sublingual gland
25. submandibular gland
26. tonsil;
* Willing to comply with all study procedures
* Willing to participate for the duration of the study
* RT follow-up planned for one of the selected AH Oncology Specialist Follow-up Sites.
Exclusion Criteria:
* Receiving palliative RT
* History of prior curative RT to the head and neck region to eradicate a malignancy.
* Incarcerated at the time of screening
* Anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07218068
Study Brief:
Protocol Section:
NCT07218068