Volver a Ensayos Clínicos
NCT03452774
SYNERGY-AI: Ensayo clínico y registro de oncología de precisión basados en inteligencia artificial.
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Descripción
Registro internacional de pacientes con cáncer que evalúa la viabilidad y utilidad clínica de una herramienta de asignación de ensayos clínicos de oncología de precisión basada en inteligencia artificial, impulsada por un programa de consejos virtuales sobre tumores (VTB), y su impacto clínico en pacientes con cáncer avanzado para facilitar la inclusión en ensayos clínicos (CTE), así como el impacto financiero y los posibles resultados de la intervención.
Evidencia documentada
Eficacia publicada para la diana/fármaco de este ensayo en cáncer colorrectal. Se refiere al fármaco o a la diana molecular, no a este ensayo concreto, y no confirma elegibilidad. Revísalo siempre con tu oncólogo.
| Fármaco / régimen | ORR | SLP (m) | Fase / n | Evidencia | Fuente |
|---|---|---|---|---|---|
| Chemotherapy plus Bevacizumab or Anti-EGFR contexto de la diana | 72% | 12.2 | Phase 3 / n=1523 | 1 | PMID 40906970 · 2026 |
| mFOLFOXIRI + Panitumumab contexto de la diana | 75% | — | Phase 3 / n=218 | 1 | PMID 41505697 · 2026 |
| mFOLFOXIRI + Panitumumab contexto de la diana | 75% | — | Phase 3 / n=218 | 1 | PMID 41505697 · 2026 |
| mFOLFOX + Panitumumab contexto de la diana | 78% | — | Phase 3 / n=217 | 1 | PMID 41505697 · 2026 |
| mFOLFOX + Panitumumab contexto de la diana | 78% | — | Phase 3 / n=217 | 1 | PMID 41505697 · 2026 |
| Chemotherapy plus Bevacizumab or Anti-EGFR contexto de la diana | 75% | 9.8 | Phase 3 / n=81 | 1 | PMID 40906970 · 2026 |
Criterios de Elegibilidad
Criterios de inclusión:
- Pacientes con neoplasias sólidas y hematológicas;
- Pacientes con biomarcadores relacionados con el cáncer, variantes genéticas, fusiones y reordenamientos (mediante inmunohistoquímica, PCR, FISH o NGS): PD-L1, MSI (MMR), Claudin18.2, HER2/Neu, carga mutacional tumoral (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, entre otros.
Estos biomarcadores deben ser determinados por el laboratorio local, un proveedor externo o una plataforma de secuenciación de nueva generación.
- Decisión de considerar la inclusión en el preselección para el ensayo clínico (CTE) por parte del médico tratante y/o el paciente.
Criterios de exclusión:
- ECOG PS > 2;
- Función orgánica anormal;
- Inclusión en un programa de cuidados paliativos.
Información del Ensayo
NCT03452774
Reclutando
Sin fase definida
50000 participantes
Ene 2018
Ubicaciones68
Puerto Rico (1)
Massive Bio SYNERGY-AI site
San Juan
United States (67)
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Albuquerque
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Ann Arbor
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Atlanta
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Aurora
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Baltimore
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Bethesda
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Billings
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Birmingham
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Boise
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Buffalo
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Chapel Hill
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Charlottesville
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Chicago
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Cincinnati
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Columbus
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Dallas
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Denver
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Duarte
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Duluth
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Fargo
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Greenville
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Hartford
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Hattiesburg
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Hempstead
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Houston
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Iowa City
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Irvine
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Jacksonville
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Kansas City
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La Jolla
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Lansing
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Little Rock
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Littleton
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Manhasset
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Mayfield Heights
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Memphis
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Miami
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Milwaukee
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Mobile
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Morgantown
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Nashville
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New Brunswick
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New Orleans
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New York
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Newark
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Norwalk
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Omaha
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Orange
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Philadelphia
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Portland
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Providence
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Salt Lake City
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San Francisco
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Savannah
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Scarborough
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Scottsdale
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Seattle
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Silver Spring
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St Louis
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Stanford
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Staten Island
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Tampa
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Temple
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Towson
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Tulsa
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Winston-Salem
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Worcester