Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03452774
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Massive Bio, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 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 : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Selin Kurnaz, PhD +1(917) 336-3319 skurnaz@massivebio.com
Contact: Kristin Johnston, RN +1(917) 336-3319 kjohnston@massivebio.com

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Selin Kurnaz, PhD Massive Bio, Inc.
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
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: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Carcinoma
Glioblastoma
Endometrial Neoplasms
Neuroendocrine Tumors
Cholangiocarcinoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Testicular Neoplasms
Pancreatic Neoplasms
Breast Neoplasms
Lung Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Colonic Neoplasms
Liver Neoplasms
 Uterine Cervical Neoplasms
Rectal Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Skin Neoplasms
Head and Neck Neoplasms
Laryngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases