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

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

INTRODUCTION

  • Org Study ID: SYNERGY-AI
  • Secondary ID: N/A
  • NCT ID: NCT03452774
  • Sponsor: Massive Bio, Inc.

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.

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 ≥50,000 patients.

  • Overall Status
    Recruiting
  • Start Date
    January 1, 2018
  • Phase
  • Study Type
    Observational

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Proportion of patients Eligible for CTE versus Actual CTE

Primary Outcome 1 - Timeframe: Through study completion

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

ELIGIBILITY

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

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Selin Kurnaz, PhD

Role: Principal Investigator

Affiliation: Massive Bio, Inc.

Overall Contact

Name: Fiona Evans, MS, Diego Barrenechea, MD

Phone: +1 (844) 627-7246, + 1 (646) 586-2753

Email: [email protected], [email protected]

LOCATION

Facility Status Contact
Facility: Massive Bio SYNERGY-AI site
Birmingham, Alabama 35294
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Mobile, Alabama 36604
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Scottsdale, Arizona 85260
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Little Rock, Arkansas 72205
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Duarte, California 91010
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Irvine, California 92618
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
La Jolla, California 92093
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Orange, California 92868
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
San Francisco, California 94143
United States
Status: Recruiting Contact: Contact
Fiona Evans
+ 1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Stanford, California 94305
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Aurora, Colorado 80045
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Denver, Colorado 80218
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Littleton, Colorado 80129
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Hartford, Connecticut 06102
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Norwalk, Connecticut 06856
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Newark, Delaware 19713
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Jacksonville, Florida 32224
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Miami, Florida 33136
United States
Status: Recruiting Contact: Contact
Fiona Evans
+ 1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Tampa, Florida 33612
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: Contact
Fiona Evans
+ 1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Savannah, Georgia 31405
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Boise, Idaho 83706
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Chicago, Illinois 60611
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Iowa City, Iowa 52242
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
New Orleans, Louisiana 70112
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Scarborough, Maine 04074
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Baltimore, Maryland 21218
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Bethesda, Maryland 20892
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Silver Spring, Maryland 20904
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Towson, Maryland 21204
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Worcester, Massachusetts 01655
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Ann Arbor, Michigan 48109
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Lansing, Michigan 48912
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Duluth, Minnesota 55805
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Hattiesburg, Mississippi 39401
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Kansas City, Missouri 64111
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
St Louis, Missouri 63110
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Billings, Montana 59102
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Omaha, Nebraska 68124
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
New Brunswick, New Jersey 08901
United States
Status: Recruiting Contact: Contact
Fiona Evans
+ 1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Albuquerque, New Mexico 87131
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Buffalo, New York 14263
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Hempstead, New York 11042
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Manhasset, New York 11030
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
New York, New York 10006
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Staten Island, New York 10314
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Chapel Hill, North Carolina 27514
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Winston-Salem, North Carolina 27157
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Fargo, North Dakota 58102
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Cincinnati, Ohio 45219
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Columbus, Ohio 43210
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Mayfield Heights, Ohio 44124
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Tulsa, Oklahoma 74146
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Portland, Oregon 97239
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Philadelphia, Pennsylvania 19044
United States
Status: Recruiting Contact: Contact
Fiona Evans
+ 1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Providence, Rhode Island 02903
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Greenville, South Carolina 29605
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Memphis, Tennessee 38105
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: Contact
Fiona Evans
+ 1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Dallas, Texas 75246
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Fiona Evans
+ 1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Temple, Texas 76508
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Salt Lake City, Utah 84112
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Charlottesville, Virginia 22908
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Seattle, Washington 98109
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Morgantown, West Virginia 26506
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]

Facility: Massive Bio SYNERGY-AI site
Milwaukee, Wisconsin 53226
United States
Status: Recruiting Contact: Contact
Fiona Evans
+1 (844) 627-7246
[email protected]