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AI-based precision oncology clinical trial matching and registry

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

Observational Massive Bio, Inc. · NCT03452774

This study is testing whether an AI tool can help match cancer patients with the right clinical trials based on their specific cancer details to see if it improves their chances of getting into trials and their overall outcomes.

Quick facts

Study typeObservational
Enrollment50000 (estimated)
SexAll
SponsorMassive Bio, Inc. Industry-sponsored
Locations68 sites (Birmingham, Alabama and 67 other locations)
Trial IDNCT03452774 on ClinicalTrials.gov

What this trial studies

The SYNERGY Registry is an international observational cohort study aimed at evaluating the feasibility and clinical utility of an Artificial Intelligence-based tool for matching cancer patients to clinical trials. It utilizes a virtual tumor board program and extracts clinical data from electronic health records to dynamically match patients with available clinical trials based on their specific cancer-related biomarkers. The study involves voluntary enrollment of patients with advanced solid and hematological malignancies, and treatment decisions remain at the discretion of their primary providers. The study will assess the impact of this matching tool on clinical trial enrollment and patient outcomes over a period of approximately 36 months.

Who should consider this trial

Good fit: Ideal candidates for this study are adults and pediatric patients with advanced solid and hematological malignancies who have already considered clinical trial enrollment.

Not a fit: Patients with early-stage cancers or those not seeking clinical trial options may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly enhance the enrollment of cancer patients in clinical trials, potentially leading to better treatment options and outcomes.

How similar studies have performed: Other studies utilizing AI for clinical trial matching have shown promise, indicating that this approach could be effective.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 67 other locations

+18 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.