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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    5000
  • sponsor
    Massive Bio, Inc.
Updated on 31 May 2021
cancer
hematologic malignancy
cebpa
il-6
BRAF
IDH2
FGFR1
KIT
KRAS
NRAS
TP53
PCR test
immunohistochemistry
ROS1
RET
VEGFR2
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 1500 patients.

Details
Condition Malignant neoplasm of prostate, Pancreatic Cancer, Non-Small Cell Lung Cancer, Neuroendocrine Tumor, Cervical Cancer, Bone marrow disorder, Adenocarcinoma, Follicular Lymphoma, urinary tract neoplasm, Ovarian disorder, Neuroectodermal Tumor, Colorectal Cancer, Disorders of cervix NOS, Endometrial Carcinoma, Cholangiocarcinoma, Malignant neoplasm of kidney, Rectal Cancer, Uterine Cancer, Lymphoma, Cancer, Preleukemia, Pancreatic disorder, leukemia, bladder cancer, bladder disorder, Central Nervous System Neoplasms, Breast Cancer, MALT Lymphoma, LIVER DISEASE, Carcinoma, Ovarian Cancer, Mantle cell lymphoma, Esophageal Diseases, Esophageal Cancer, Laryngeal Cancer, Glioblastoma Multiforme, Malignant neoplasm of colon, melanoma, Transitional cell carcinoma, Lung Neoplasm, skin cancer, Dermatosis, HEPATIC NEOPLASM, Myelosclerosis with myeloid metaplasia, Lymphoma, Neoplasm of unspecified nature of digestive system, MYELOPROLIFERATIVE DISORDER, MYELODYSPLASTIC SYNDROME, Gastropathy, Gastric Cancer, head and neck cancer, Malignant neoplasm of testis, Stomach Discomfort, Pancreatic Disorders, Metastatic Melanoma, Vulvar Dysplasia and Carcinoma, Non-Hodgkin's Lymphoma, Colon Cancer Screening, Cancer/Tumors, Prostate Cancer, Early, Recurrent, Colon cancer; rectal cancer, Ovarian Function, Advanced Cancer, Esophageal Carcinoma, Breast Cancer Diagnosis, Ewing's Family Tumors, Urothelial Cancer, Laryngeal Carcinoma, Gastric Carcinoma, Advanced Malignancies, Myeloproliferative Neoplasms, Recurrent Ovarian Cancer, Congenital Skin Diseases, Leukemia (Pediatric), Cancer (Pediatric), Islet Ce417ll Cancer, Neurectoderma, Mismatch Repair Deficiency, Cancer, Metastatic, Cancer, Advanced, BRCA Gene Rearrangement, Kidney Cancer, Skin Conditions, Myelofibrosis, Lung Cancer, Colon Cancer, Endometrial Cancer, Prostate Cancer, Testicular Cancer, Esophageal Disorders, Malignant Melanoma, Liver Cancer, Malignant Adenoma, Stomach Cancer, Neoplasms, Bladder Disorders, Liver Disorders, Biliary Tract Cancer, Renal Cancer, Digestive System Neoplasms, Marginal Zone Lymphoma, Bladder Carcinoma, Urologic Cancer, Urothelial Carcinoma, Cancer Metastatic, COVID-19, COVID-19, Coronavirus Disease (COVID-19), COVID-19, COVID-19, Pathogen Infection Covid-19 Infection, *Corona Virus Infection, *COVID-19 Infection, Corona Virus Disease 2019(COVID-19), COVID-19, COVID-19, Treat and Prevent Covid-19 Infection, COVID-19, COVID-19 Infection, *COVID-19, COVID-19, Covid-19, COVID-19, COVID-19 Pneumonia, COVID-19, COVID-19, COVID-19, Covid-19, Pathogen Infection Covid-19 Infection, COVID-19, COVID-19, COVID-19, Use of Stem Cells for COVID-19 Treatment, COVID-19, COVID-19, Hospitalized Patients With Covid-19 Pneumonia, Corona Virus Disease 2019(COVID-19), COVID-19 Pneumonia, COVID-19; Cardiovascular Diseases, Community-acquired Pneumonia, Influenza, COVID-19, Old Age, Usability, Visio Telephony, Confinement, Covid-19, COVID-19 Pneumonia, COVID-19 Pneumonia, Acute Respiratory Distress Syndrome Caused by COVID-19, COVID-19 Pneumonia, Corona Virus Disease 2019(COVID-19), Old Age, Usability, Visio Telephony, Confinement, Covid-19, SARS-CoV-2 (COVID-19) Infection, COVID-19 Pneumonia, Corona Virus Disease 2019(COVID-19), COVID-19 Pneumonia, Severe Coronavirus Disease (COVID-19), Acute Respiratory Distress Syndrome Caused by COVID-19, COVID-19 Pneumonia, COVID-19, Hydroxychloroquine Sulfate, SARS-CoV-2 (COVID-19) Infection, COVID-19 Pneumonia, COVID-19, Hydroxychloroquine Sulfate, Anxiety Related to the COVID-19 Pandemic, Acute Respiratory Distress Syndrome Caused by COVID-19, Severe Coronavirus Disease (COVID-19), COVID-19 Pneumonia, *COVID-19 Infection, Severe Coronavirus Disease (COVID-19), COVID-19 by SARS-CoV-2 Infection, Cancer, Advanced, breast carcinoma, cervical carcinoma, myelodysplastic syndromes, neck cancer, myeloproliferative neoplasm, myeloproliferative disorders, primary cancer, primary malignant neoplasm, cns tumors, cns tumor, cns neoplasm, central nervous system tumors, central nervous system tumor, glioblastoma, non-hodgkin's lymphoma (nhl), cancer advanced, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, leukemias, malignancy, cancers, malignancies, malignant tumor, malignant tumors, gastric cancers, carcinoma of the bladder, cancer, breast, esophagus cancer, oesophageal cancer, cancer, liver, cancer, hepatic, cancer, hepatocellular, liver cancers, nsclc, skin cancers, cervical cancer, uterine, myelodysplastic syndrome (mds), cancer of the pancreas, cancers metastatic, carcinoma of the cervix uteri, carcinoma of the cervix, cervix cancer, cancer of the cervix, carcinoma of cervix, ovarian tumors, cancer, renal, pancreatic cancers, cancer, pancreatic, carcinomas, cancer of the esophagus, oesophageal carcinoma, bladder tumor, testis cancer, rectal carcinoma, neuroendocrine tumors, neuroendocrine tumour
Treatment Clinical Trial Matching
Clinical Study IdentifierNCT03452774
SponsorMassive Bio, Inc.
Last Modified on31 May 2021

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, 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, 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
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