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.
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
🗓️ Study Start (Actual) 1 January 2018
🗓️ Primary Completion (Estimated) December 2026
✅ Study Completion (Estimated) June 2027
👥 Enrollment (Estimated) 50000
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 13 February 2018
  • First Submitted that Met QC Criteria 24 February 2018
  • First Posted 2 March 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 March 2024
  • Last Update Posted 15 March 2024
  • Last Verified March 2024