Breast Cancer Clinical Trial
Official title:
SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
NCT number | NCT03452774 |
Other study ID # | SYNERGY-AI |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2018 |
Est. completion date | June 2027 |
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.
Status | Recruiting |
Enrollment | 50000 |
Est. completion date | June 2027 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Massive Bio, Inc | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Massive Bio, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients Eligible for CTE versus Actual CTE | CTE Accrual | Through study completion, an average of 1 year | |
Secondary | Impact of CTE on Overall Survival (OS), estimated by Kaplan-Meier and Cox multivariable survival analysis | OS | 4 years | |
Secondary | Impact of CTE on Progression-Free Survival (PFS), estimated by Kaplan-Meier and Cox multivariable survival analysis | PFS | 4 years | |
Secondary | Identification of Barriers to CTE | To identify barriers to accruals to clinical trials, as measured and reported by a questionnaire | Through study completion, an average of 1 year | |
Secondary | Real World Data Analytics | To 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 | |
Secondary | Virtual Tumor Board Utilization | VTB Use Rate | Through study completion, an average of 1 year | |
Secondary | Time from Intervention to Actual CTE (months) | Time to CTE | Through study completion, an average of 1 year |
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