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

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

Sponsors

Lead Sponsor: Massive Bio, Inc.

Source Massive Bio, Inc.
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 ≥1500 patients.

Overall Status Recruiting
Start Date 2018-01-01
Completion Date 2022-12-01
Primary Completion Date 2022-06-01
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Proportion of patients Eligible for CTE versus Actual CTE Through study completion, an average of 1 year
Secondary Outcome
Measure Time Frame
Impact of CTE on Overall Survival (OS), estimated by Kaplan-Meier and Cox multivariable survival analysis 4 years
Impact of CTE on Progression-Free Survival (PFS), estimated by Kaplan-Meier and Cox multivariable survival analysis 4 years
Identification of Barriers to CTE Through study completion, an average of 1 year
Real World Data Analytics Through study completion, an average of 1 year
Virtual Tumor Board Utilization Through study completion, an average of 1 year
Time from Intervention to Actual CTE (months) Through study completion, an average of 1 year
Enrollment 5000
Condition
Intervention

Intervention Type: Other

Intervention Name: Clinical Trial Matching

Description: 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.

Arm Group Label: Study Group

Eligibility

Sampling Method:

Non-Probability Sample

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, 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

Gender:

All

Minimum Age:

N/A

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Selin Kurnaz, PhD Principal Investigator Massive Bio, Inc.
Overall Contact

Last Name: Selin Kurnaz, PhD

Phone: +1(917) 336-3319

Email: [email protected]

Location
Facility: Status: Contact: Massive Bio, Inc Kristin Johnston, RN 844-627-7246 [email protected]
Location Countries

United States

Verification Date

2021-05-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Study Group

Description: 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).

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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