Through this Clinical Sequencing Evidence-Generating Research (CSER2) with Enhanced
Diversity project we will complete a trial (The Texas KidsCanSeq Study) comparing the results
of targeted cancer panel sequencing versus genome-scale testing in pediatric cancer patients
across diverse clinical settings. We will compare the targeted cancer panel to germline whole
exome sequencing (WES) of unselected childhood cancer patients (n=1100) and WES,
transcriptome sequencing and copy number array of FFPE tumor samples for the subset of
patients with high-risk tumors (n=360). We will build on our success completing the CSER
program BASIC3 exome sequencing trial (which included 60% Hispanic and African-American
patients from a single large academic center) in this large multi-institutional study of an even
more diverse patient population from five heterogeneous healthcare settings across Texas. The
trial will be led by an experienced multi-PI team of Drs. Plon (medical geneticist), Parsons
(pediatric oncologist) and McGuire (ethicist and health policy expert). We will assess clinical
utility of these tests by measuring the frequency of diagnostic and/or actionable germline and
tumor findings and the effect on treatment decisions (Aim 1). We will compare uptake by first
degree relatives for familial genetic testing and recommended cancer surveillance by race,
ethnicity and clinical settings (Aim 2). We will describe perceived utility (clinical, psychological,
and pragmatic) by surveying and interviewing parents and participating pediatric oncologists
(n=40) (Aim 3). Working with our pediatric cancer stakeholders, including advocates, BASIC3
study parents, and national organizations, we will create and evaluate the use of culturally
sensitive educational materials, including videos in English and Spanish, improved integrated
genomic test reports and counseling materials, and will compare in-person versus telemedicine
exome results disclosure (Aim 4). Finally, we will provide data to guide future application of
clinical genomics through three innovative pilot projects focused on health economics, decision
support for cancer surveillance and whole genome sequencing (Aim 5). Baylor College of
Medicine, Texas Children’s Hospital, and our partner institutions across the state are ideally
suited to conduct this study and play leadership roles in CSER2 consortium activities based on
our longstanding pediatric oncology and cancer genetics expertise, extensive experience in
CLIA-certified clinical germline and cancer genomic diagnostic testing, and a track record of
scholarship in ethical and social implications of genomics and health disparities research.
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