SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
Purpose
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.
Conditions
- Cancer, Metastatic
- Cancer
- Cancer of Pancreas
- Cancer of Liver
- Cancer of Stomach
- Cancer Liver
- Cancer of Rectum
- Cancer of Kidney
- Cancer of Esophagus
- Cancer of Cervix
- Cancer of Colon
- Cancer of Larynx
- Cancer, Lung
- Cancer, Breast
- Cancer, Advanced
- Cancer Prostate
- Cancer of Neck
- Cancer of Skin
- Neuroendocrine Tumors
- Carcinoma
- Mismatch Repair Deficiency
- BRCA Gene Rearrangement
- Non Hodgkin Lymphoma
- Leukemia
- Non Small Cell Lung Cancer
- Cholangiocarcinoma
- Glioblastoma
- Central Nervous System Tumor
- Melanoma
- Urothelial Carcinoma
- Bladder Cancer
- Ovarian Cancer
- Endometrial Cancer
- Testicular Cancer
- Breast Cancer
- COVID
- Myelofibrosis
- Myeloproliferative Neoplasm
- Myeloproliferative Disorders
- Follicular Lymphoma
- Mantle Cell Lymphoma
- Marginal Zone Lymphoma
- Myelodysplastic Syndromes
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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). |
|
Recruiting Locations
Birmingham, Alabama 35294
Mobile, Alabama 36604
Scottsdale, Arizona 85260
Little Rock, Arkansas 72205
Duarte, California 91010
Irvine, California 92618
La Jolla, California 92093
Orange, California 92868
San Francisco, California 94143
Stanford, California 94305
Aurora, Colorado 80045
Denver, Colorado 80218
Littleton, Colorado 80129
Hartford, Connecticut 06102
Norwalk, Connecticut 06856
Newark, Delaware 19713
Jacksonville, Florida 32224
Miami, Florida 33136
Tampa, Florida 33612
Atlanta, Georgia 30322
Savannah, Georgia 31405
Boise, Idaho 83706
Chicago, Illinois 60611
Iowa City, Iowa 52242
New Orleans, Louisiana 70112
Scarborough, Maine 04074
Baltimore, Maryland 21218
Bethesda, Maryland 20892
Silver Spring, Maryland 20904
Towson, Maryland 21204
Worcester, Massachusetts 01655
Ann Arbor, Michigan 48109
Lansing, Michigan 48912
Duluth, Minnesota 55805
Hattiesburg, Mississippi 39401
Kansas City, Missouri 64111
St Louis, Missouri 63110
Billings, Montana 59102
Omaha, Nebraska 68124
New Brunswick, New Jersey 08901
Albuquerque, New Mexico 87131
Buffalo, New York 14263
Hempstead, New York 11042
Manhasset, New York 11030
New York, New York 10006
Staten Island, New York 10314
Chapel Hill, North Carolina 27514
Winston-Salem, North Carolina 27157
Fargo, North Dakota 58102
Cincinnati, Ohio 45219
Columbus, Ohio 43210
Mayfield Heights, Ohio 44124
Tulsa, Oklahoma 74146
Portland, Oregon 97239
Philadelphia, Pennsylvania 19044
Providence, Rhode Island 02903
Greenville, South Carolina 29605
Memphis, Tennessee 38105
Nashville, Tennessee 37203
Dallas, Texas 75246
Houston, Texas 77030
Temple, Texas 76508
Salt Lake City, Utah 84112
Charlottesville, Virginia 22908
Seattle, Washington 98109
Morgantown, West Virginia 26506
Milwaukee, Wisconsin 53226
San Juan, Puerto Rico 00917
More Details
- NCT ID
- NCT03452774
- Status
- Recruiting
- Sponsor
- Massive Bio, Inc.
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.