SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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 ≥50,000 patients.

Official Title
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SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry

Conditions
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Carcinoma, COVID, Cancer, Metastatic, Cancer, Cancer of Pancreas, Cancer of Liver, Cancer of Stomach, Cancer Liver, Cancer of Rectum, Cancer of Kidney, Cancer of Esophagus, Cancer of Cervix, Cancer of Colon, Cancer of Larynx, Cancer, Lung, Cancer, Breast, Cancer, Advanced, Cancer Prostate, Cancer of Neck, Cancer of Skin, Neuroendocrine Tumors, Mismatch Repair Deficiency, BRCA Gene Rearrangement, Non Hodgkin Lymphoma, Leukemia, Non Small Cell Lung Cancer, Cholangiocarcinoma, Glioblastoma, Central Nervous System Tumor, Melanoma, Urothelial Carcinoma, Bladder Cancer, Ovarian Cancer, Endometrial Cancer, Testicular Cancer, Breast Cancer, Myelofibrosis, Myeloproliferative Neoplasm, Myeloproliferative Disorders, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Myelodysplastic Syndromes

Intervention / Treatment
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* Other: Clinical Trial Matching


Participation Criteria
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Eligibility Criteria
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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, HER2/Neu, 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, CEACAM, NRG1, 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>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). | Other: Clinical Trial Matching<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients Eligible for CTE versus Actual CTE | CTE Accrual | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of CTE on Overall Survival (OS), estimated by Kaplan-Meier and Cox multivariable survival analysis | OS | 4 years | 
| Impact of CTE on Progression-Free Survival (PFS), estimated by Kaplan-Meier and Cox multivariable survival analysis | PFS | 4 years | 
| Identification of Barriers to CTE | To identify barriers to accruals to clinical trials, as measured and reported by a questionnaire | Through study completion, an average of 1 year | 
| Real World Data Analytics | To Analyze Individual Standard of Care Chemotherapy Utilization (nominal), across treatment lines (numeric); data will be combined and aggregated to report chemotherapy utilization rate (%). | Through study completion, an average of 1 year | 
| Virtual Tumor Board Utilization | VTB Use Rate | Through study completion, an average of 1 year | 
| Time from Intervention to Actual CTE (months) | Time to CTE | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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artificial intelligence, virtual tumor board, clinical trial, clinical trial matching, electronic medical record, machine learning, cost of care, targeted therapy, immunotherapy, precision medicine, precision oncology, cancer, value based care, real world data, data analytics