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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Proportion of patients Eligible for CTE versus Actual CTE [Срок оценки: Through study completion, an average of 1 year]

Вторичные конечные точки (6)

• Impact of CTE on Overall Survival (OS), estimated by Kaplan-Meier and Cox multivariable survival analysis [Срок оценки: 4 years]
• Impact of CTE on Progression-Free Survival (PFS), estimated by Kaplan-Meier and Cox multivariable survival analysis [Срок оценки: 4 years]
• Identification of Barriers to CTE [Срок оценки: Through study completion, an average of 1 year]
• Real World Data Analytics [Срок оценки: Through study completion, an average of 1 year]
• Virtual Tumor Board Utilization [Срок оценки: Through study completion, an average of 1 year]
• Time from Intervention to Actual CTE (months) [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• ECOG PS > 2;
• Abnormal organ function;
• Hospice enrollment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 67 центров

• 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
• … и ещё 59 центров

Пуэрто-Рико · 1 центр

• Massive Bio SYNERGY-AI site — San Juan

Идентификаторы

NCT: NCT03452774 · SYNERGY-AI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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