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

October 25, 2025 updated by: Massive Bio, Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00917
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Mobile, Alabama, United States, 36604
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Irvine, California, United States, 92618
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • La Jolla, California, United States, 92093
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Orange, California, United States, 92868
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • San Francisco, California, United States, 94143
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Stanford, California, United States, 94305
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Littleton, Colorado, United States, 80129
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Norwalk, Connecticut, United States, 06856
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Miami, Florida, United States, 33136
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Idaho
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Maine
      • Scarborough, Maine, United States, 04074
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Bethesda, Maryland, United States, 20892
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Silver Spring, Maryland, United States, 20904
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Towson, Maryland, United States, 21204
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Hempstead, New York, United States, 11042
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Manhasset, New York, United States, 11030
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • New York, New York, United States, 10006
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Staten Island, New York, United States, 10314
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Mayfield Heights, Ohio, United States, 44124
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19044
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
      • Temple, Texas, United States, 76508
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Massive Bio SYNERGY-AI site
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients Eligible for CTE versus Actual CTE
Time Frame: Through study completion, an average of 1 year
CTE Accrual
Through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Impact of CTE on Overall Survival (OS), estimated by Kaplan-Meier and Cox multivariable survival analysis
Time Frame: 4 years
OS
4 years
Impact of CTE on Progression-Free Survival (PFS), estimated by Kaplan-Meier and Cox multivariable survival analysis
Time Frame: 4 years
PFS
4 years
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
Through study completion, an average of 1 year
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 (%).
Through study completion, an average of 1 year
Virtual Tumor Board Utilization
Time Frame: Through study completion, an average of 1 year
VTB Use Rate
Through study completion, an average of 1 year
Time from Intervention to Actual CTE (months)
Time Frame: Through study completion, an average of 1 year
Time to CTE
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massive Bio, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Selin Kurnaz, PhD, Massive Bio, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2038

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2040

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SYNERGY-AI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Dietary Supplements

Sponsor/Collaborators

Locations

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