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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT02423356
Eligibility Criteria:
Inclusion Criteria:
1. Patients must be at least 18 years old at the time of informed consent
2. Patients must be able to speak and read English.
3. Patients must be able to provide written informed consent and HIPAA authorization
4. Patients must have a current diagnosis of sarcoma, lymphoma, or HER2(-) breast cancer
5. Patients must be deemed appropriate for doxorubicin-based chemotherapy regardless of individual diagnosis or stage of disease.
6. Patients must have planned treatment with doxorubicin:
* Patients with sarcoma must have an initial planned regimen including 75 mg/m2 doxorubicin for at least 4 cycles. NOTE: Patients can be on additional chemotherapeutic agents.
* Patients with lymphoma must have an initial planned regimen including 50 mg/m2of doxorubicin for at least 6 cycles. NOTE: Patients can be on additional chemotherapeutic agents.
* Patients with breast cancer must have an initial planned regimen including 60 mg/m2 of doxorubicin for at least 4 cycles. Breast cancer patient enrollment will stop once 60 breast cancer patients have been enrolled.
NOTE: Patients can be on additional chemotherapeutic agents.
7. Patients must have their echocardiograms performed such that strain may be calculated using either GE or Tomtec software.
Exclusion Criteria:
1. Clinical history of heart failure or ejection fraction (EF) on initial exam is \<53%.
2. Initial echocardiograms are not interpretable.
3. Wall motion abnormalities are present on initial echocardiograms.
4. Strain on initial echocardiograms cannot be calculated.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02423356
Study Brief:
Protocol Section:
NCT02423356