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


2018-01-01


2026-12


2027-06


50000

Study Overview

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

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.

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.

  • 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
  • OTHER: Clinical Trial Matching
  • SYNERGY-AI

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2018-02-13  

N/A  

2024-03-12  

2018-02-24  

N/A  

2024-03-15  

2018-03-02  

N/A  

2024-03  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A


Allocation:
N/A


Interventional Model:
N/A


Masking:
N/A


Arms and Interventions

Participant Group/ArmIntervention/Treatment
: Study Group

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

  • 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
Primary Outcome MeasuresMeasure DescriptionTime Frame
Proportion of patients Eligible for CTE versus Actual CTECTE AccrualThrough study completion, an average of 1 year
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Impact of CTE on Overall Survival (OS), estimated by Kaplan-Meier and Cox multivariable survival analysisOS4 years
Impact of CTE on Progression-Free Survival (PFS), estimated by Kaplan-Meier and Cox multivariable survival analysisPFS4 years
Identification of Barriers to CTETo identify barriers to accruals to clinical trials, as measured and reported by a questionnaireThrough study completion, an average of 1 year
Real World Data AnalyticsTo 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 UtilizationVTB Use RateThrough study completion, an average of 1 year
Time from Intervention to Actual CTE (months)Time to CTEThrough study completion, an average of 1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Selin Kurnaz, PhD

Phone Number: +1(917) 336-3319

Email: skurnaz@massivebio.com

Study Contact Backup

Name: Amanda Huttis, RN

Phone Number: +1(917) 336-3319

Email: ahuttis@massivebio.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • PRINCIPAL_INVESTIGATOR: Selin Kurnaz, PhD, Massive Bio, Inc.

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available