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

  • STATUS
    Recruiting
  • End date
    Jun 22, 2025
  • participants needed
    50000
  • sponsor
    Massive Bio, Inc.
Updated on 7 October 2022
cancer
hematologic malignancy
cebpa
il-6
BRAF
IDH2
FGFR1
KIT
KRAS
NRAS
TP53
PCR test
immunohistochemistry
ROS1
RET
VEGFR2
HER2
EGFR
ccnd1
pd-l1
advanced cancer
primary cancer
FGFR2
PTEN
erbb2
BRCA1
ATM
BRCA2
PDGFRA
STK11
LKB1
FGFR3
HRAS
ESR1
palb2
CHEK2
PMS2
BAP1
MSH2
men1
hematologic cancer
tsc1
igf1r
fbxw7
ccnd2
pdcd1
programmed cell death protein 1
tsc2
mycl1
vegfa
multiple endocrine neoplasia type 1
proto-oncogene tyrosine-protein kinase ros
znf703
prdm1

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.

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.

Details
Condition 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
Treatment Clinical Trial Matching
Clinical Study IdentifierNCT03452774
SponsorMassive Bio, Inc.
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note