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 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT01192204
Eligibility Criteria:
Inclusion Criteria:
1. Ages: 21 to 80
2. Microscopically confirmed premalignant oral epithelial disease
3. No previous history of cancer (with the exception of basal cell carcinoma of the skin)
4. Tobacco free for at least six weeks prior to entrance in the trial and remain tobacco-free for the three month duration of the study
5. Availability for necessary study follow-up evaluations (every 10 to 14 days during the trial)
6. Capable of providing informed consent.
Exclusion Criteria:
1. Previous history of cancer (with the exception of basal cell carcinoma of the skin)
2. Current use of tobacco products or refusal to remain tobacco-free for the three month duration of the study
3. Lack of microscopically confirmed premalignant oral epithelial changes
4. Microscopic diagnosis of oral squamous cell carcinoma
5. Previous history of radiation therapy on same side of the head and neck region
6. History of allergy to any kind of berry
7. Women who are determined to be pregnant or plan to be pregnant during the trial
8. Women who are nursing.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT01192204
Study Brief:
Protocol Section:
NCT01192204