SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
International registry for cancer patients evaluating the feasibility and clinical utility of
 an Artificial Intelligence-based precision oncology clinical trial matching tool, powered by
 a virtual tumor boards (VTB) program, and its clinical impact on pts with advanced cancer to
 facilitate clinical trial enrollment (CTE), as well as the financial impact, and potential
 outcomes of the intervention.
The SYNERGY Registry is an international prospective, observational cohort study of eligible
 adult and pediatric pts with advanced solid and hematological malignancies, for whom the
 decision to consider CTE has already been made by their primary providers (PP). Using a
 proprietary application programming interface (API) linked to existing electronic health
 records (EHR) platforms, individual clinical data is extracted, analyzed and matched to a
 parametric database of existing institutional and non-institutional CT. Machine learning
 algorithms allow for dynamic matching based on CT allocation and availability for optimized
 matching. Patients voluntarily enroll into the registry, which is non-interventional with no
 protocol-mandated tests/procedures - all treatment decisions are made at the discretion of PP
 in consultation with their pts, based on the AI CT matching report, and VTB support. CTE will
 be assessed on variables including biomarkers, barriers to enrollment. Study duration
 anticipated as ~36 mo (~24-mo enrollment followed by 12 mo of data collection, to occur every
 3 mo). The primary analysis will be performed 12 mo after last pt enrolled. The impact time
 to initiation of CTE on PFS and OS will be estimated by Kaplan-Meier and Cox multivariable
 survival analysis. Enrollment is ongoing, with a target of ≥1500 patients.
Inclusion Criteria:

 -  Pts with solid and hematological malignancies;

 -  Pts cancer-related biomarkers, gene variants, fusion and rearrangements (by
 immunohistochemistry, PCR, FISH or NGS): PD-L1, MSI (MMR), Claudin18.2, Tumor
 mutational burden/load (TMB), ABL1, ACVR1B, AKT1, AKT2, AKT3, ALK, APC, AR, ATM, ATRX,
 AURKA, AURKB, BAP1, BCL2, BCL6, BRAF, BRCA1, BRCA2, BTK, CCND1, CCND2, CCND3, CDK4,
 CDK6, CDKN1A/B, CEBPA, CHEK1, CHEK2, CSF1R, CTNNB1, DAXX, DDR1/2, DNMT3A, EGFR, ERBB2,
 ERBB3, ERBB4, ERCC4, ER, ESR1, FANCA, FAS, FBXW7, FGFR1, FGFR2, FGFR3, FGFR4, FLT3,
 GATA3, GATA6, GNAS, HDAC1, HGF, HRAS, IDH1, IDH2, IGF1R, JAK1, JAK2, JAK3, KDR
 (VEGFR2), KIT, KRAS, MAP2K2 (MEK2), MAP3K1, MCL1, MDM2, MDM4, MEN1, MET, MSH2, MSH3,
 MSH6, MTOR, MUTYH, MYC, MYCL (MYCL1), NF1, NF2, NOTCH1, NPM1, NRAS, NTRK1, NTRK2,
 NTRK3, PALB2, PARP1, PARP2, PARP3, PBRM1, PDCD1 (PD1), PDCD1LG2 (PD-L2), PDGFRA,
 PDGFRB, PIK3C, PMS2, POLD1, POLE, PRDM1, PTCH1, PTEN, RAF1, RB1, RET, RICTOR, ROS1,
 RPTOR, SDHA/B/C, SMAD, SMARC, SMO, STK11, TGFBR2, TP53, TSC1, TSC2, VEGFA, VHL, WT1,
 ZNF217, ZNF703, among others.

 These biomarkers should be determined by local laboratory, external vendor, or next
 generation sequencing platform

 -  Decision to consider clinical trial pre-screening enrollment (CTE) by primary provider
 and/or patient

 Exclusion Criteria:

 -  ECOG PS > 2;

 -  Abnormal organ function;

 -  Hospice enrollment