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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT02290834
Eligibility Criteria:
Inclusion Criteria:
* Breast cancer patients treated with chemotherapy- Group 1 (experimental group)
* Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +/- imaging components of study
* New diagnosis histologically confirmed invasive breast cancer
* Treatment plan to include chemotherapy
* Female subjects age ≥ 60 years.
* Life expectancy ≥ 1 year
* Karnofsky Performance Score (KPS) ≥ 80
* Ability to understand and the willingness to sign a written informed consent document.
* Non-treated breast cancer patient controls- Group 2 (control group)
* Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +/- imaging components of study:
* New diagnosis histologically confirmed invasive breast cancer
* Treatment plan does not include chemotherapy
* Age ≥ 60 years.
* Life expectancy ≥ 1 year
* Karnofsky Performance Score (KPS) ≥ 80
* Ability to understand and the willingness to sign a written informed consent document.
* Healthy control subjects- Group 3 (control group)
* Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +/- imaging components of study:
* Age ≥ 60 years.
* Life expectancy ≥ 1 year
* Karnofsky Performance Score (KPS) ≥ 80
* Ability to understand and the willingness to sign a written informed consent document.
* Participants with well-controlled vascular risk factors, such as treated hypertension, treated hyperlipidemia or well-controlled Type II diabetes (glucose levels \<250) may be included.
* Serum Pregnancy Testing: STAT quantitative serum hCG pregnancy testing for all women of childbearing potential. Imaging will not start until and unless the test result returns negative.
Exclusion Criteria:
* Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study:
* Participants with clinical or radiographic evidence of metastatic CNS disease
* Subjects with MMSE scores below 24
* Active or history of major psychiatric disorders such as schizophrenia, schizoaffective disorder, major affective disorder in mid-life, or treatment with ECT (Mild depression that is well treated with stable dose of SSRI antidepressants may be allowed).
* Substance abuse within the past 2 years
* Huntington's disease, hydrocephalus or seizure disorder
* In addition to exclusion criteria above, participants who exhibit any of the following conditions at screening will not be eligible for admission into imaging portion of the study:
* Participants with contraindications to MRI (i.e., implanted metal including pacemakers, cerebral spinal fluid shunts, aneurysm clips, artificial heart valves, ear implants or metal/foreign objects in the eyes and those with a history of claustrophobia), injuries to the eyes with metal without X-ray documentation that metal was removed
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
60 Years
Study:
NCT02290834
Study Brief:
Protocol Section:
NCT02290834