Status:
RECRUITING
SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
Lead Sponsor:
Massive Bio, Inc.
Conditions:
Cancer, Metastatic
Cancer
Eligibility:
All Genders
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 tum...
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 consid...
Eligibility Criteria
Inclusion
- 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
- ECOG PS \> 2;
- Abnormal organ function;
- Hospice enrollment
Key Trial Info
Start Date :
January 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2040
Estimated Enrollment :
50000 Patients enrolled
Trial Details
Trial ID
NCT03452774
Start Date
January 1 2018
End Date
June 1 2040
Last Update
October 28 2025
Active Locations (68)
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1
Massive Bio SYNERGY-AI site
Birmingham, Alabama, United States, 35294
2
Massive Bio SYNERGY-AI site
Mobile, Alabama, United States, 36604
3
Massive Bio SYNERGY-AI site
Scottsdale, Arizona, United States, 85260
4
Massive Bio SYNERGY-AI site
Little Rock, Arkansas, United States, 72205