PRIMARY OBJECTIVE: The primary objective of the study is to determine feasibility of providing pediatric cancer patients with access to personalized treatment options and clinical management recommendations based on ex vivo drug sensitivity testing (DST) and genomic profiling.
SECONDARY OBJECTIVE: The secondary objective of the study is to compare individual outcomes (response and disease-free survival) in patients with pediatric cancers treated with DST-guided therapy as compared to non-DST guided (conventional) therapy.
EXPLORATORY OBJECTIVE: To explore associations between genetic abnormalities in malignancies and ex vivo drug response.
Age
0–21
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients aged 21 years or younger at the time of enrollment on this study of any gender, race or ethnicity.
* Subjects with suspected or confirmed diagnosis of recurrent or refractory cancer
* Subjects who are scheduled for or have recently had biopsy or tumor excised (solid tumors) or bone marrow aspirate (blood cancers)
* Subjects willing to have a blood draw or buccal swab done for the purposes of genetic testing
* Subjects or their parents or legal guardians willing to sign informed consent
* Subjects aged 7 to 17 willing to sign assent
You may not be if
Subjects who do not have malignant tissue available and accessible
The amount of excised malignant tissue is not sufficient for the ex vivo drug testing and/or genetic profiling.
Patients with newly diagnosed tumors and tumors that have high (\>90%) cure rate with safe standard therapy.
Clareo Health | Ex Vivo Drug Sensitivity Testing and Mutation Profiling
