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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT02934360
Eligibility Criteria:
Inclusion Criteria:
* Non-small cell lung: Male or Female Adult patient \>= 21 years old
* Breast only: Female Adult patient \>= 21 years old
* Previously diagnosed with one of the following cancers:
Breast or Non-small Cell Lung
* Cancer has progressed to at least Stage III or higher for lung cancer or,
* Cancer has progressed to stage IV (metastatic) breast cancer
* Participating in standard of care cancer therapy requiring frequent treatments, typically intravenous chemotherapy visits (or as determined by the standard of care for the particular cancer assessed), of a minimum of three (3) treatment visits planned in 9 months from date of enrollment where a clinical assessment will be conducted
Exclusion Criteria:
* Physician assessment that obtaining two extra whole blood specimens with minimum volume of 5 mL per treatment visit is contraindicated
* Stage I and II Non-small Cell Lung Cancer
* Stage I through III breast cancer
* Pregnant or planning to become pregnant during the course of the study
* Unable to obtain informed consent from subject or their legal representative
* Life expectancy is less than 9 months
* Presence of one or more of the following other chronic diseases
* Another type of cancer except for non-melanomatous skin tumors
* Autoimmune disease requiring DMARDS or Biologics
* Infectious disease requiring prolonged intravenous antibiotics or hospitalization
* Renal disease specifically those in End Stage Renal Failure
* Recent (\< 3 weeks) major trauma or major surgical procedure(s) or radiation therapy prior to enrollment in the study
* Recent (\< 2 months) major occlusive arterial event such as MI or CVA prior to enrollment in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02934360
Study Brief:
Protocol Section:
NCT02934360