Clinical Trials Logo

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

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

See also
  Status Clinical Trial Phase
Recruiting NCT03591848 - Pilote Study of an Online Decision Support Tool for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03095352 - A Randomized Phase II Study of Pembrolizumab, an Anti-PD (Programmed Cell Death)-1 Antibody, in Combination With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease Phase 2
Active, not recruiting NCT01472094 - Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Active, not recruiting NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in People With Metastatic Cancer Phase 2
Recruiting NCT03667716 - COM701 in Subjects With Advanced Solid Tumors Phase 1
Recruiting NCT03709134 - Genomic Markers for Measuring Metastatic Risk in Breast Cancer Following Primary Treatment
Recruiting NCT02894398 - Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant Phase 2
Active, not recruiting NCT01857193 - Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer Phase 1
Recruiting NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Recruiting NCT03432429 - REI-EXCISE iKnife Study N/A
Active, not recruiting NCT02139358 - Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer Phase 1/Phase 2
Recruiting NCT03615573 - Survey Study: Financial Impact of Breast Cancer Treatment
Completed NCT03323333 - Psychosocial Intervention Pilot for Partners in BRCA Testing N/A
Terminated NCT01649258 - Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy Phase 1
Withdrawn NCT03285607 - MCS110 Combined With Neoadjuvant Doxorubicin, Cyclophosphamide, and Weekly Paclitaxel in Patients With Hormone-Receptor Positive and HER2- Breast Cancer Phase 1
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Recruiting NCT01992432 - Brain Functional MRI in Older Women With Breast Cancer (Brain fMRI-BC)
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A