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:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT01828502
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 2 years and ≤ 12 years at the time of study entry.
* Currently undergoing treatment for cancer at the time of enrollment, at least 28 days post diagnosis.
* The child must reside 5 days a week with a household smoker (defined as a person who smokes greater than 10 cigarettes daily).
* Child must be potty trained.
* Parent/Legal Guardian ≥ 18 years of age.
* Parent/Legal Guardian who accompanies the child to the first visit must accompany the child to all other visits. This person does not need to be the household smoker, but must be willing to educate the smoker on results at the visit and take the education handout home to them.
* Parent/Legal Guardian must have a working phone to complete the week 5 follow-up phone call.
* Able and willing to sign informed consent/assent.
* Signed HIPAA compliant research authorization.
Exclusion Criteria:
* Planned hospitalization within 3 days of any scheduled study visit (due to the urine cotinine measurement representing the previous 48-72 hours of tobacco exposure.
* Inability to perform the initial cotinine test.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
12 Years
Study:
NCT01828502
Study Brief:
Protocol Section:
NCT01828502