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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT02686203
Eligibility Criteria:
Inclusion Criteria:
1. Male and female patients 18 to 70 years of age diagnosed with cancer (with or without metastasis) including but not limited to breast, ovarian, cervical, uterine, renal, bladder, gastric, pancreas, lung, thyroid, colorectal, small and large intestine, testicle and prostate cancer who have either
1. failed standard treatment for their type of cancer
2. decline standard treatment and interested in non-invasive treatment or change in life style
3. have time to decide on treatment options and interested in non-invasive treatment
2. Confirm cancer diagnosis using biopsy, biomarkers or imaging (PET/CT, MRI, CT, Ultrasound, etc.)
3. Karnofsky performance status score of at least 60% for lung cancer and at least 50% for all other cancers at the screening visit
4. Life expectancy of at least 12 weeks
5. Patients must have adequate organ function as defined below:
1. AST (SGOT)/ALT(SGPT) \<3x upper limit of normal (ULN).
2. Serum creatinine \<2.0 mg/dL.
3. Serum bilirubin \<3 mg/dL
6. Signed written informed consent to participate in the study independently by patient.
7. Ability to comply with the requirements of the study.
Exclusion Criteria:
1. Participation in an interventional investigational trial within 30 days of the screening visit.
2. Receipt of chemotherapy or radiotherapy within 1 month of the screening visits
3. Patients with other concurrent severe and/or uncontrolled medical condition which could compromise participation in the study or interfere with the evaluation of the investigational therapy effect (i.e. active infection, uncontrolled diabetes, uncontrolled hypertension, congestive cardiac failure, unstable angina, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper gastrointestinal tract ulceration).
4. Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder or any chronic condition susceptible, in the opinion of the investigator or the sponsor, of interfering with the conduct of the study.
5. who are likely to be non-compliant or uncooperative during the study. -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02686203
Study Brief:
Protocol Section:
NCT02686203