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NCT number NCT03452774
Study type Observational [Patient Registry]
Source Massive Bio, Inc.
Contact Selin Kurnaz, PhD
Phone +1(917) 336-3319
Status Recruiting
Phase N/A
Start date January 1, 2018
Completion date December 2022

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.

Clinical Trial 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 ≥1500 patients.

Study Design

Related Conditions & MeSH terms

  • Bladder Cancer
  • Brain Neoplasms
  • 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, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Carcinoma, Transitional Cell
  • Central Nervous System Neoplasms
  • Central Nervous System Tumor
  • Cholangiocarcinoma
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Endometrial Cancer
  • Endometrial Neoplasms
  • Esophageal Neoplasms
  • Glioblastoma
  • Head and Neck Neoplasms
  • Kidney Neoplasms
  • Laryngeal Neoplasms
  • Leukemia
  • Liver Neoplasms
  • Lung Neoplasms
  • Lymphoma, Non-Hodgkin
  • Melanoma
  • Mismatch Repair Deficiency
  • Neoplasms
  • Neoplastic Syndromes, Hereditary
  • 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
  • Urinary Bladder Neoplasms
  • Urothelial Carcinoma
  • Uterine Cervical Neoplasms

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