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Cancer, MetastaticNCT03452774

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

An observational study of Cancer, Metastatic and Cancer, run by Massive Bio, Inc. at 68 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Cancer, Metastatic, Cancer, Cancer of Pancreas
What is being tested?
Clinical Trial Matching
How many people
50,000 participants
Where
68 sitesin 2 countries
Study dates
1 Jan 2018to Jun 2040
How long will I take part?
36 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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).

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

68 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

68 sites in 2 countries

United States67 sites, 67 recruiting
  • Massive Bio SYNERGY-AI site

    Albuquerque, New Mexico, 87131

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Ann Arbor, Michigan, 48109

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Atlanta, Georgia, 30322

    Fiona Evans, + 1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Aurora, Colorado, 80045

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Baltimore, Maryland, 21218

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Bethesda, Maryland, 20892

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Billings, Montana, 59102

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Birmingham, Alabama, 35294

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Boise, Idaho, 83706

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Buffalo, New York, 14263

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Chapel Hill, North Carolina, 27514

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Charlottesville, Virginia, 22908

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Chicago, Illinois, 60611

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Cincinnati, Ohio, 45219

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Columbus, Ohio, 43210

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Dallas, Texas, 75246

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Denver, Colorado, 80218

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Duarte, California, 91010

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Duluth, Minnesota, 55805

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Fargo, North Dakota, 58102

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Greenville, South Carolina, 29605

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Hartford, Connecticut, 06102

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Hattiesburg, Mississippi, 39401

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Hempstead, New York, 11042

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Houston, Texas, 77030

    Fiona Evans, + 1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Iowa City, Iowa, 52242

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Irvine, California, 92618

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Jacksonville, Florida, 32224

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Kansas City, Missouri, 64111

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    La Jolla, California, 92093

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Lansing, Michigan, 48912

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Little Rock, Arkansas, 72205

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Littleton, Colorado, 80129

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Manhasset, New York, 11030

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Mayfield Heights, Ohio, 44124

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Memphis, Tennessee, 38105

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Miami, Florida, 33136

    Fiona Evans, + 1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Milwaukee, Wisconsin, 53226

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Mobile, Alabama, 36604

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Morgantown, West Virginia, 26506

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Nashville, Tennessee, 37203

    Fiona Evans, + 1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    New Brunswick, New Jersey, 08901

    Fiona Evans, + 1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    New Orleans, Louisiana, 70112

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    New York, New York, 10006

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Newark, Delaware, 19713

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Norwalk, Connecticut, 06856

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Omaha, Nebraska, 68124

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Orange, California, 92868

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Philadelphia, Pennsylvania, 19044

    Fiona Evans, + 1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Portland, Oregon, 97239

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Providence, Rhode Island, 02903

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Salt Lake City, Utah, 84112

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    San Francisco, California, 94143

    Fiona Evans, + 1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Savannah, Georgia, 31405

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Scarborough, Maine, 04074

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Scottsdale, Arizona, 85260

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Seattle, Washington, 98109

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Silver Spring, Maryland, 20904

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    St Louis, Missouri, 63110

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Stanford, California, 94305

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Staten Island, New York, 10314

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Tampa, Florida, 33612

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Temple, Texas, 76508

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Towson, Maryland, 21204

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Tulsa, Oklahoma, 74146

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Winston-Salem, North Carolina, 27157

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting
  • Massive Bio SYNERGY-AI site

    Worcester, Massachusetts, 01655

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting

Other trials in United States

Puerto Rico1 site, 1 recruiting
  • Massive Bio SYNERGY-AI site

    San Juan, 00917

    Fiona Evans, +1 (844) 627-7246, fevans@massivebio.com

    Recruiting

Other trials in Puerto Rico

About this study

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.

Read the 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.

Being tested
Clinical Trial Matching
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
Medical subject headings
Neoplasm Metastasis, Neoplasms, Pancreatic Neoplasms, Liver Neoplasms, Stomach Neoplasms, Carcinoma, Hepatocellular, Rectal Neoplasms, Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical Trial MatchingOther

    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 groups in NCT03452774
Study groupRoleWhat they receive
Study GroupEligible 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).
Receives: Other: Clinical Trial Matching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients Eligible for CTE versus Actual CTE

    CTE Accrual

    Measured: Through study completion, an average of 1 year

Secondary outcomes (6)
  1. Impact of CTE on Overall Survival (OS), estimated by Kaplan-Meier and Cox multivariable survival analysis

    OS

    Measured: 4 years

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

    PFS

    Measured: 4 years

  3. Identification of Barriers to CTE

    To identify barriers to accruals to clinical trials, as measured and reported by a questionnaire

    Measured: Through study completion, an average of 1 year

  4. Real World Data Analytics

    To Analyze Individual Standard of Care Chemotherapy Utilization (nominal), across treatment lines (numeric); data will be combined and aggregated to report chemotherapy utilization rate (%).

    Measured: Through study completion, an average of 1 year

  5. Virtual Tumor Board Utilization

    VTB Use Rate

    Measured: Through study completion, an average of 1 year

  6. Time from Intervention to Actual CTE (months)

    Time to CTE

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2018
  2. Study start1 Jan 2018
  3. Primary completionDec 2038 (estimated)
  4. Study completionJun 2040 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50,000 participants (estimated)
Target duration
36 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03452774
Sponsor's protocol ID
SYNERGY-AI
Status last verified
Oct 2025
First submitted
13 Feb 2018
Last updated
28 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, Metastatic and Cancer, run by Massive Bio, Inc. at 68 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fiona Evans, MS (+1 (844) 627-7246, fevans@massivebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients Eligible for CTE versus Actual CTE (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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