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NCT03452774 | RECRUITING | Cancer, Metastatic

SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
Sponsor:

Massive Bio, Inc.

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 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.

Condition or disease

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

Intervention/treatment

Clinical Trial Matching

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 consider CTE has already been made by their primary providers (PP). Using a proprietary application programming interface (API) linked to existing electronic health records (EHR) platforms, individual clinical data is extracted, analyzed and matched to a parametric database of existing institutional and non-institutional CT. Machine learning algorithms allow for dynamic matching based on CT allocation and availability for optimized matching. Patients voluntarily enroll into the registry, which is non-interventional with no protocol-mandated tests/procedures - all treatment decisions are made at the discretion of PP in consultation with their pts, based on the AI CT matching report, and VTB support. CTE will be assessed on variables including biomarkers, barriers to enrollment. Study duration anticipated as \~36 mo (\~24-mo enrollment followed by 12 mo of data collection, to occur every 3 mo). The primary analysis will be performed 12 mo after last pt enrolled. The impact time to initiation of CTE on PFS and OS will be estimated by Kaplan-Meier and Cox multivariable survival analysis. Enrollment is ongoing, with a target of ≥50,000 patients.

Study Type : OBSERVATIONAL
Estimated Enrollment : 50000 participants
Official Title : SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
Actual Study Start Date : 2018-01-01
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2027-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry

Location Details

NCT03452774

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

Massive Bio, Inc

New York, New York, United States, 10006