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2018-01-01
2026-12
2027-06
50000
NCT03452774
Massive Bio, Inc.
Massive Bio, Inc.
OBSERVATIONAL
SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
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.
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-02-13 | N/A | 2024-03-12 |
2018-02-24 | N/A | 2024-03-15 |
2018-03-02 | N/A | 2024-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | 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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Proportion of patients Eligible for CTE versus Actual CTE | CTE Accrual | Through study completion, an average of 1 year |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Impact of CTE on Overall Survival (OS), estimated by Kaplan-Meier and Cox multivariable survival analysis | OS | 4 years |
| Impact of CTE on Progression-Free Survival (PFS), estimated by Kaplan-Meier and Cox multivariable survival analysis | PFS | 4 years |
| Identification of Barriers to CTE | 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 | 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 | VTB Use Rate | Through study completion, an average of 1 year |
| Time from Intervention to Actual CTE (months) | Time to CTE | Through study completion, an average of 1 year |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Selin Kurnaz, PhD Phone Number: +1(917) 336-3319 Email: skurnaz@massivebio.com |
Study Contact Backup Name: Amanda Huttis, RN Phone Number: +1(917) 336-3319 Email: ahuttis@massivebio.com |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
