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

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ClinicalTrials.gov Identifier: NCT03452774
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
Massive Bio, Inc.

Study Description
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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 Intervention/treatment
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 Other: 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 ≥1500 patients.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Study Group
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).
 Other: Clinical Trial Matching
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.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients Eligible for CTE versus Actual CTE [ Time Frame: Through study completion, an average of 1 year ]
    CTE Accrual


Secondary Outcome Measures :
  1. Impact of CTE on Overall Survival (OS), estimated by Kaplan-Meier and Cox multivariable survival analysis [ Time Frame: 4 years ]
    OS

  2. Impact of CTE on Progression-Free Survival (PFS), estimated by Kaplan-Meier and Cox multivariable survival analysis [ Time Frame: 4 years ]
    PFS

  3. Identification of Barriers to CTE [ Time Frame: Through study completion, an average of 1 year ]
    To identify barriers to accruals to clinical trials, as measured and reported by a questionnaire

  4. Real World Data Analytics [ Time Frame: Through study completion, an average of 1 year ]
    To Analyze Individual Standard of Care Chemotherapy Utilization (nominal), across treatment lines (numeric); data will be combined and aggregated to report chemotherapy utilization rate (%).

  5. Virtual Tumor Board Utilization [ Time Frame: Through study completion, an average of 1 year ]
    VTB Use Rate

  6. Time from Intervention to Actual CTE (months) [ Time Frame: Through study completion, an average of 1 year ]
    Time to CTE


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Observational cohort study of eligible adult and pediatric pts with advanced solid and hematological malignancies, for whom the decision to consider clinical trial enrollment (CTE) has already been made by their primary providers (PP).
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, 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452774


Contacts
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Contact: Selin Kurnaz, PhD +1(917) 336-3319 skurnaz@massivebio.com
Contact: Kristin Johnston, RN +1(917) 336-3319 kjohnston@massivebio.com

Locations
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United States, New York
Massive Bio, Inc Recruiting
New York, New York, United States, 10006
Contact: Kristin Johnston, RN    844-627-7246    support@massivebio.com   
Sponsors and Collaborators
Massive Bio, Inc.
Investigators
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Principal Investigator: Selin Kurnaz, PhD Massive Bio, Inc.
More Information
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Additional Information:

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Responsible Party: Massive Bio, Inc.
ClinicalTrials.gov Identifier: NCT03452774    
Other Study ID Numbers: SYNERGY-AI
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Massive Bio, Inc.:
artificial intelligence
virtual tumor board
clinical trial
clinical trial matching
electronic medical record
machine learning
cost of care
targeted therapy
 immunotherapy
precision medicine
precision oncology
cancer
value based care
real world data
data analytics
Additional relevant MeSH terms:
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Lymphoma
Carcinoma
Glioblastoma
Lymphoma, Mantle-Cell
Endometrial Neoplasms
Neuroendocrine Tumors
Cholangiocarcinoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Testicular Neoplasms
Breast Neoplasms
Pancreatic Neoplasms
Lung Neoplasms
Esophageal Neoplasms
Stomach Neoplasms
 Colonic Neoplasms
Liver Neoplasms
Rectal Neoplasms
Uterine Cervical Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Head and Neck Neoplasms
Skin Neoplasms
Laryngeal Neoplasms
Myelodysplastic Syndromes
Myeloproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases