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 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT00006457
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Current cigarette smokers
* At least 20 cigarettes a day
* No variation of more than 10 in the number of cigarettes smoked per day within the past 3 months
* At least 10 years of smoking any amount
* Failed to stop smoking after at least one attempt to quit within the last 3 years
* Prior stage I non-small cell lung cancer allowed if surgically resected with at least a lobectomy
* No concurrent evidence of lung cancer
* Willing to undergo 2 bronchoscopies
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0
Life expectancy:
* Not specified
Hematopoietic:
* CBC normal
* Hemostasis normal
Hepatic:
* PT and PTT normal
Renal:
* Blood chemistries normal
* Nonfasting glucose no greater than 200 mg/dL
* No active renal disease
* No urinary tract infection by urinalysis (trace protein allowed)
Cardiovascular:
* EKG normal
* No coronary artery disease requiring continuous medication
Pulmonary:
* Chest radiograph normal (postsurgical changes allowed)
* No acute or significant chronic abnormality
* FEV1 greater than 1.8 L or 75% predicted
* No chronic obstructive pulmonary disease requiring continuous medication
Other:
* No known hypersensitivity or prior adverse reaction to oltipraz
* No inmates or prisoners
* No medical or psychological condition that would preclude study (e.g., acute psychosis)
* No prior malignancy except nonmelanomatous skin cancer, cervical dysplasia, or curatively treated stage I or II cancer of the head and neck
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* At least 3 months since prior potential chemoprevention agent (e.g., oltipraz, retinoids, or acetylcysteine)
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00006457
Study Brief:
Protocol Section:
NCT00006457