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 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
NCT ID:
NCT00611650
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Current or former smoker who has smoked ≥ 30 pack-years (i.e., 1 pack per day for ≥ 30 years)
* A former smoker is defined as one who has stopped smoking for ≥ 1 year
* C-reactive protein level \> 1.2 mg/L
* One or more areas of dysplasia with a surface diameter \> 1.2 mm on autofluorescence bronchoscopy
* No carcinoma in situ or invasive cancer on bronchoscopy
* No abnormal spiral chest CT scan suspicious of lung cancer
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Willing to take Polyphenon E or placebo twice a day regularly
* Willing to undergo bronchoscopy and spiral chest CT scan
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Creatinine normal
* Bilirubin normal
* AST and ALT normal
* Alkaline phosphatase normal
* No chronic active hepatitis or liver cirrhosis
* No severe heart disease (e.g., unstable angina or chronic congestive heart failure)
* No ongoing gastric ulcer
* No acute bronchitis or pneumonia within the past month
* No known reaction to xylocaine, salbutamol, midazolam, or alfentanil
* No known allergy to green tea and/or corn starch, gelatin, or other nonmedicinal ingredients
* No medical condition, such as acute or chronic respiratory failure or bleeding disorder, that, in the opinion of the investigator, could jeopardize patient safety during study participation
PRIOR CONCURRENT THERAPY:
* No concurrent consumption of \> 7 cups of tea a week
* No other concurrent natural health products containing green tea compounds
* No concurrent antiarrhythmic agents
* No concurrent anticoagulants, such as warfarin or heparin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
74 Years
Study:
NCT00611650
Study Brief:
Protocol Section:
NCT00611650