SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinical Trial Matching.
- Who it may be relevant to
- Registry conditions: Cancer, Metastatic, Cancer, Cancer of Pancreas, Cancer of Liver. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Puerto Rico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
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.
Interventions
- Other Clinical Trial Matching
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.
Primary outcome measures
- Proportion of patients Eligible for CTE versus Actual CTE [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (6)
- Impact of CTE on Overall Survival (OS), estimated by Kaplan-Meier and Cox multivariable survival analysis [Time frame: 4 years]
- Impact of CTE on Progression-Free Survival (PFS), estimated by Kaplan-Meier and Cox multivariable survival analysis [Time frame: 4 years]
- Identification of Barriers to CTE [Time frame: Through study completion, an average of 1 year]
- Real World Data Analytics [Time frame: Through study completion, an average of 1 year]
- Virtual Tumor Board Utilization [Time frame: Through study completion, an average of 1 year]
- Time from Intervention to Actual CTE (months) [Time frame: Through study completion, an average of 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 67 centers
- Massive Bio SYNERGY-AI site — Birmingham
- Massive Bio SYNERGY-AI site — Mobile
- Massive Bio SYNERGY-AI site — Scottsdale
- Massive Bio SYNERGY-AI site — Little Rock
- Massive Bio SYNERGY-AI site — Duarte
- Massive Bio SYNERGY-AI site — Irvine
- Massive Bio SYNERGY-AI site — La Jolla
- Massive Bio SYNERGY-AI site — Orange
- … and 59 more centers
Puerto Rico · 1 center
- Massive Bio SYNERGY-AI site — San Juan
Identifiers
NCT: NCT03452774 · SYNERGY-AI