Clinical trial NCT03452774: SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
Official title: SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Carcinoma
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
COVID
Myelofibrosis
Myeloproliferative Neoplasm
Myeloproliferative Disorders
Follicular Lymphoma
Mantle Cell Lymphoma
Marginal Zone Lymphoma
Myelodysplastic Syndromes
Keywords: 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
Lead sponsor: Massive Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-02
Enrollment: 50000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Observational cohort study of eligible adult and pediatric pts with advanced solid and hematological malignancies, for whom the decision to consider clinical trial enrollment (CTE) has already been made by their primary providers (PP).

Brief summary: 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.

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

Primary outcomes:
measure: Proportion of patients Eligible for CTE versus Actual CTE
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Impact of CTE on Overall Survival (OS), estimated by Kaplan-Meier and Cox multivariable survival analysis
timeFrame: 4 years
measure: Impact of CTE on Progression-Free Survival (PFS), estimated by Kaplan-Meier and Cox multivariable survival analysis
timeFrame: 4 years
measure: Identification of Barriers to CTE
timeFrame: Through study completion, an average of 1 year
measure: Real World Data Analytics
timeFrame: Through study completion, an average of 1 year
measure: Virtual Tumor Board Utilization
timeFrame: Through study completion, an average of 1 year
measure: Time from Intervention to Actual CTE (months)
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Massive Bio, Inc
state: New York
Study officials:
affiliation: Massive Bio, Inc.
name: Selin Kurnaz, PhD
role: PRINCIPAL_INVESTIGATOR
References: