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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03452774
• Other study ID #: SYNERGY-AI
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: June 2027

Study information

• Verified date: March 2024
• Source: Massive Bio, Inc.
• Contact: Selin Kurnaz, PhD
• Phone: +1(917) 336-3319
• Email: skurnaz[@]massivebio.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 (CTE), as well as the financial impact, and potential outcomes of the intervention.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: June 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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

Related Conditions & MeSH terms

• Bladder Cancer
• BRCA Gene Rearrangement
• Breast Cancer
• Breast Neoplasms
• Cancer
• Cancer Liver
• Cancer of Cervix
• Cancer of Colon
• Cancer of Esophagus
• Cancer of Kidney
• Cancer of Larynx
• Cancer of Liver
• Cancer of Neck
• Cancer of Pancreas
• Cancer of Rectum
• Cancer of Skin
• Cancer of Stomach
• Cancer Prostate
• Cancer, Advanced
• Cancer, Breast
• Cancer, Lung
• Cancer, Metastatic
• Carcinoma
• Carcinoma, Renal Cell
• Central Nervous System Neoplasms
• Central Nervous System Tumor
• Cholangiocarcinoma
• Colonic Neoplasms
• COVID
• Endometrial Cancer
• Endometrial Neoplasms
• Esophageal Neoplasms
• Follicular Lymphoma
• Glioblastoma
• Head and Neck Neoplasms
• Kidney Neoplasms
• Laryngeal Neoplasms
• Leukemia
• Liver Neoplasms
• Lung Neoplasms
• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma
• Marginal Zone Lymphoma
• Melanoma
• Mismatch Repair Deficiency
• Myelodysplastic Syndromes
• Myelofibrosis
• Myeloproliferative Disorders
• Myeloproliferative Neoplasm
• Nervous System Neoplasms
• Neuroendocrine Tumors
• Non Hodgkin Lymphoma
• Non Small Cell Lung Cancer
• Ovarian Cancer
• Pancreatic Neoplasms
• Rectal Neoplasms
• Skin Neoplasms
• Stomach Neoplasms
• Testicular Cancer
• Testicular Neoplasms
• Urothelial Carcinoma
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Massive Bio, Inc	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Massive Bio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients Eligible for CTE versus Actual CTE	CTE Accrual	Through study completion, an average of 1 year
Secondary	Impact of CTE on Overall Survival (OS), estimated by Kaplan-Meier and Cox multivariable survival analysis	OS	4 years
Secondary	Impact of CTE on Progression-Free Survival (PFS), estimated by Kaplan-Meier and Cox multivariable survival analysis	PFS	4 years
Secondary	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
Secondary	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
Secondary	Virtual Tumor Board Utilization	VTB Use Rate	Through study completion, an average of 1 year
Secondary	Time from Intervention to Actual CTE (months)	Time to CTE	Through study completion, an average of 1 year

External Links

•   SYNERGY-AI - Journal of Clinical Oncology (JCO)