SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
Trial ID: NCT03452774
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2018-01-01
Completion date: 2040-06
Sponsor: Massive Bio, Inc.
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
Interventions: Clinical Trial Matching
Locations: Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site; Massive Bio SYNERGY-AI site
Countries: United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; United States; Puerto Rico
Enrollment: 50000
Age range: None - None
Sex: ALL

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.

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

Outcomes:
Proportion of patients Eligible for CTE versus Actual CTE