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

NCT03452774 | Recruiting

• 1 other identifier: SYNERGY-AI
• Study Type: observational
• Target: 50,000
• Locations: 2 countries
• Sites: 68

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients Eligible for CTE versus Actual CTE

  CTE Accrual

  Through study completion, an average of 1 year

Secondary Outcomes (6)

• Impact of CTE on Overall Survival (OS), estimated by Kaplan-Meier and Cox multivariable survival analysis

  4 years

• Impact of CTE on Progression-Free Survival (PFS), estimated by Kaplan-Meier and Cox multivariable survival analysis

  4 years

• Identification of Barriers to CTE

  Through study completion, an average of 1 year

• Real World Data Analytics

  Through study completion, an average of 1 year

• Virtual Tumor Board Utilization

  Through study completion, an average of 1 year

Study Arms (1)

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

Interventions

Clinical Trial Matching OTHER

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.

Study Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• ECOG PS \> 2;
• Abnormal organ function;
• Hospice enrollment

Sponsors & Collaborators

• Massive Bio, Inc.: lead

Study Sites (68)

Massive Bio SYNERGY-AI site

Birmingham, Alabama, 35294, United States

RECRUITING

Massive Bio SYNERGY-AI site

Mobile, Alabama, 36604, United States

RECRUITING

Massive Bio SYNERGY-AI site

Scottsdale, Arizona, 85260, United States

RECRUITING

Massive Bio SYNERGY-AI site

Little Rock, Arkansas, 72205, United States

RECRUITING

Massive Bio SYNERGY-AI site

Duarte, California, 91010, United States

RECRUITING

Massive Bio SYNERGY-AI site

Irvine, California, 92618, United States

RECRUITING

Massive Bio SYNERGY-AI site

La Jolla, California, 92093, United States

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Massive Bio SYNERGY-AI site

Orange, California, 92868, United States

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Massive Bio SYNERGY-AI site

San Francisco, California, 94143, United States

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Massive Bio SYNERGY-AI site

Stanford, California, 94305, United States

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Massive Bio SYNERGY-AI site

Aurora, Colorado, 80045, United States

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Massive Bio SYNERGY-AI site

Denver, Colorado, 80218, United States

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Massive Bio SYNERGY-AI site

Littleton, Colorado, 80129, United States

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Massive Bio SYNERGY-AI site

Hartford, Connecticut, 06102, United States

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Massive Bio SYNERGY-AI site

Norwalk, Connecticut, 06856, United States

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Massive Bio SYNERGY-AI site

Newark, Delaware, 19713, United States

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Massive Bio SYNERGY-AI site

Jacksonville, Florida, 32224, United States

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Massive Bio SYNERGY-AI site

Miami, Florida, 33136, United States

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Massive Bio SYNERGY-AI site

Tampa, Florida, 33612, United States

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Massive Bio SYNERGY-AI site

Atlanta, Georgia, 30322, United States

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Massive Bio SYNERGY-AI site

Savannah, Georgia, 31405, United States

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Massive Bio SYNERGY-AI site

Boise, Idaho, 83706, United States

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Massive Bio SYNERGY-AI site

Chicago, Illinois, 60611, United States

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Massive Bio SYNERGY-AI site

Iowa City, Iowa, 52242, United States

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Massive Bio SYNERGY-AI site

New Orleans, Louisiana, 70112, United States

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Massive Bio SYNERGY-AI site

Scarborough, Maine, 04074, United States

RECRUITING

Massive Bio SYNERGY-AI site

Baltimore, Maryland, 21218, United States

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Massive Bio SYNERGY-AI site

Bethesda, Maryland, 20892, United States

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Massive Bio SYNERGY-AI site

Silver Spring, Maryland, 20904, United States

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Massive Bio SYNERGY-AI site

Towson, Maryland, 21204, United States

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Massive Bio SYNERGY-AI site

Worcester, Massachusetts, 01655, United States

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Massive Bio SYNERGY-AI site

Ann Arbor, Michigan, 48109, United States

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Massive Bio SYNERGY-AI site

Lansing, Michigan, 48912, United States

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Massive Bio SYNERGY-AI site

Duluth, Minnesota, 55805, United States

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Massive Bio SYNERGY-AI site

Hattiesburg, Mississippi, 39401, United States

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Massive Bio SYNERGY-AI site

Kansas City, Missouri, 64111, United States

RECRUITING

Massive Bio SYNERGY-AI site

St Louis, Missouri, 63110, United States

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Massive Bio SYNERGY-AI site

Billings, Montana, 59102, United States

RECRUITING

Massive Bio SYNERGY-AI site

Omaha, Nebraska, 68124, United States

RECRUITING

Massive Bio SYNERGY-AI site

New Brunswick, New Jersey, 08901, United States

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Massive Bio SYNERGY-AI site

Albuquerque, New Mexico, 87131, United States

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Massive Bio SYNERGY-AI site

Buffalo, New York, 14263, United States

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Massive Bio SYNERGY-AI site

Hempstead, New York, 11042, United States

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Massive Bio SYNERGY-AI site

Manhasset, New York, 11030, United States

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Massive Bio SYNERGY-AI site

New York, New York, 10006, United States

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Massive Bio SYNERGY-AI site

Staten Island, New York, 10314, United States

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Massive Bio SYNERGY-AI site

Chapel Hill, North Carolina, 27514, United States

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Massive Bio SYNERGY-AI site

Winston-Salem, North Carolina, 27157, United States

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Massive Bio SYNERGY-AI site

Fargo, North Dakota, 58102, United States

RECRUITING

Massive Bio SYNERGY-AI site

Cincinnati, Ohio, 45219, United States

RECRUITING

Massive Bio SYNERGY-AI site

Columbus, Ohio, 43210, United States

RECRUITING

Massive Bio SYNERGY-AI site

Mayfield Heights, Ohio, 44124, United States

RECRUITING

Massive Bio SYNERGY-AI site

Tulsa, Oklahoma, 74146, United States

RECRUITING

Massive Bio SYNERGY-AI site

Portland, Oregon, 97239, United States

RECRUITING

Massive Bio SYNERGY-AI site

Philadelphia, Pennsylvania, 19044, United States

RECRUITING

Massive Bio SYNERGY-AI site

Providence, Rhode Island, 02903, United States

RECRUITING

Massive Bio SYNERGY-AI site

Greenville, South Carolina, 29605, United States

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Massive Bio SYNERGY-AI site

Memphis, Tennessee, 38105, United States

RECRUITING

Massive Bio SYNERGY-AI site

Nashville, Tennessee, 37203, United States

RECRUITING

Massive Bio SYNERGY-AI site

Dallas, Texas, 75246, United States

RECRUITING

Massive Bio SYNERGY-AI site

Houston, Texas, 77030, United States

RECRUITING

Massive Bio SYNERGY-AI site

Temple, Texas, 76508, United States

RECRUITING

Massive Bio SYNERGY-AI site

Salt Lake City, Utah, 84112, United States

RECRUITING

Massive Bio SYNERGY-AI site

Charlottesville, Virginia, 22908, United States

RECRUITING

Massive Bio SYNERGY-AI site

Seattle, Washington, 98109, United States

RECRUITING

Massive Bio SYNERGY-AI site

Morgantown, West Virginia, 26506, United States

RECRUITING

Massive Bio SYNERGY-AI site

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Massive Bio SYNERGY-AI site

San Juan, 00917, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms; Pancreatic Neoplasms; Liver Neoplasms; Stomach Neoplasms; Carcinoma, Hepatocellular; Rectal Neoplasms; Kidney Neoplasms; Esophageal Neoplasms; Uterine Cervical Neoplasms; Colonic Neoplasms; Laryngeal Neoplasms; Lung Neoplasms; Breast Neoplasms; Prostatic Neoplasms; Head and Neck Neoplasms; Skin Neoplasms; Neuroendocrine Tumors; Carcinoma; Turcot syndrome; Lymphoma, Non-Hodgkin; Leukemia; Carcinoma, Non-Small-Cell Lung; Cholangiocarcinoma; Glioblastoma; Central Nervous System Neoplasms; Melanoma; Carcinoma, Transitional Cell; Urinary Bladder Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Testicular Neoplasms; Primary Myelofibrosis; Myeloproliferative Disorders; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Liver Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Colorectal Neoplasms; Intestinal Neoplasms; Intestinal Diseases; Rectal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Esophageal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases; Colonic Diseases; Otorhinolaryngologic Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Thoracic Neoplasms; Lung Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Nervous System Neoplasms; Nervous System Diseases; Nevi and Melanomas; Urinary Bladder Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Testicular Diseases; Bone Marrow Diseases; Lymphoma, B-Cell

Study Officials

• Selin Kurnaz, PhD

  Massive Bio, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiona Evans, MS

CONTACT

+1 (844) 627-7246; fevans@massivebio.com

Diego Barrenechea, MD

CONTACT

+ 1 (646) 586-2753; dbarrenechea@massivebio.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: March 2, 2018
• Study Start: January 1, 2018
• Primary Completion (Estimated): December 1, 2038
• Study Completion (Estimated): June 1, 2040
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (67); PR (1)