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 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT00101335
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of oral leukoplakia with hyperplasia or dysplasia
* Documented by baseline biopsy of oral lesions suspicious for leukoplakia
* For patients using dentures over the past 6 months, only lesions located on the ventral-lateral tongue or floor of the mouth are allowed
* No leukoplakia/hyperplasia secondary to mechanical irritation
* No carcinoma in situ of the oral cavity
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Not specified
Life expectancy
* At least 1 year
Hematopoietic
* Hemoglobin ≥ 10 g/dL (women) OR ≥ 11 g/dL (men)
Hepatic
* AST or ALT normal
* Bilirubin normal
Renal
* Creatinine normal OR
* Creatinine clearance ≥ 60 mL/min
Cardiovascular
* No myocardial infarction within the past 12 months
* No known active ischemic cardiac disease by stress test or echocardiogram
Gastrointestinal
* No history of gastrointestinal hemorrhage
* No known gastrointestinal ulcers within the past 2 years unless there is documentation of healed lesions by upper endoscopy
* No active or suspected peptic ulcer disease
* Negative stool guaiac test
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 months after study treatment
* No use of snuff or chewing tobacco within the past 2 months
* No active invasive malignancy within the past 3 years except nonmelanoma skin cancer or in situ carcinomas
* No clinical evidence of chronic infectious disease
* No clinical evidence of connective tissue disease
* No known hypersensitivity (asthma, urticaria, or acute rhinitis induced by NSAIDs) to aspirin or other NSAIDs
* No known hypersensitivity to sulfonamides
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* At least 6 months since prior chronic or frequent use of systemic glucocorticoids
* No concurrent chronic or frequent use of systemic glucocorticoids
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No prior chronic or frequent (\> 100 mg per day aspirin equivalent) use of nonsteroidal anti-inflammatory drugs (NSAIDs) for 7 of the past 14 days
* At least 3 months since prior experimental therapy
* No concurrent chronic or frequent use of NSAIDs
* Cardioprotective doses of aspirin ≤ 100 mg daily are allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00101335
Study Brief:
Protocol Section:
NCT00101335