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
Massive Bio SYNERGY-AI site
Birmingham, Alabama 35294
Birmingham, Alabama 35294
Massive Bio SYNERGY-AI site
Mobile, Alabama 36604
Mobile, Alabama 36604
Massive Bio SYNERGY-AI site
Scottsdale, Arizona 85260
Scottsdale, Arizona 85260
Massive Bio SYNERGY-AI site
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Massive Bio SYNERGY-AI site
Duarte, California 91010
Duarte, California 91010
Massive Bio SYNERGY-AI site
Irvine, California 92618
Irvine, California 92618
Massive Bio SYNERGY-AI site
La Jolla, California 92093
La Jolla, California 92093
Massive Bio SYNERGY-AI site
Orange, California 92868
Orange, California 92868
Massive Bio SYNERGY-AI site
San Francisco, California 94143
San Francisco, California 94143
Massive Bio SYNERGY-AI site
Stanford, California 94305
Stanford, California 94305
Massive Bio SYNERGY-AI site
Aurora, Colorado 80045
Aurora, Colorado 80045
Massive Bio SYNERGY-AI site
Denver, Colorado 80218
Denver, Colorado 80218
Massive Bio SYNERGY-AI site
Littleton, Colorado 80129
Littleton, Colorado 80129
Massive Bio SYNERGY-AI site
Hartford, Connecticut 06102
Hartford, Connecticut 06102
Massive Bio SYNERGY-AI site
Norwalk, Connecticut 06856
Norwalk, Connecticut 06856
Massive Bio SYNERGY-AI site
Newark, Delaware 19713
Newark, Delaware 19713
Massive Bio SYNERGY-AI site
Jacksonville, Florida 32224
Jacksonville, Florida 32224
Massive Bio SYNERGY-AI site
Miami, Florida 33136
Miami, Florida 33136
Massive Bio SYNERGY-AI site
Tampa, Florida 33612
Tampa, Florida 33612
Massive Bio SYNERGY-AI site
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Massive Bio SYNERGY-AI site
Savannah, Georgia 31405
Savannah, Georgia 31405
Massive Bio SYNERGY-AI site
Boise, Idaho 83706
Boise, Idaho 83706
Massive Bio SYNERGY-AI site
Chicago, Illinois 60611
Chicago, Illinois 60611
Massive Bio SYNERGY-AI site
Iowa City, Iowa 52242
Iowa City, Iowa 52242
Massive Bio SYNERGY-AI site
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
Massive Bio SYNERGY-AI site
Scarborough, Maine 04074
Scarborough, Maine 04074
Massive Bio SYNERGY-AI site
Baltimore, Maryland 21218
Baltimore, Maryland 21218
Massive Bio SYNERGY-AI site
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Massive Bio SYNERGY-AI site
Silver Spring, Maryland 20904
Silver Spring, Maryland 20904
Massive Bio SYNERGY-AI site
Towson, Maryland 21204
Towson, Maryland 21204
Massive Bio SYNERGY-AI site
Worcester, Massachusetts 01655
Worcester, Massachusetts 01655
Massive Bio SYNERGY-AI site
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Massive Bio SYNERGY-AI site
Lansing, Michigan 48912
Lansing, Michigan 48912
Massive Bio SYNERGY-AI site
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Massive Bio SYNERGY-AI site
Hattiesburg, Mississippi 39401
Hattiesburg, Mississippi 39401
Massive Bio SYNERGY-AI site
Kansas City, Missouri 64111
Kansas City, Missouri 64111
Massive Bio SYNERGY-AI site
St Louis, Missouri 63110
St Louis, Missouri 63110
Massive Bio SYNERGY-AI site
Billings, Montana 59102
Billings, Montana 59102
Massive Bio SYNERGY-AI site
Omaha, Nebraska 68124
Omaha, Nebraska 68124
Massive Bio SYNERGY-AI site
New Brunswick, New Jersey 08901
New Brunswick, New Jersey 08901
Massive Bio SYNERGY-AI site
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
Massive Bio SYNERGY-AI site
Buffalo, New York 14263
Buffalo, New York 14263
Massive Bio SYNERGY-AI site
Hempstead, New York 11042
Hempstead, New York 11042
Massive Bio SYNERGY-AI site
Manhasset, New York 11030
Manhasset, New York 11030
Massive Bio SYNERGY-AI site
New York, New York 10006
New York, New York 10006
Massive Bio SYNERGY-AI site
Staten Island, New York 10314
Staten Island, New York 10314
Massive Bio SYNERGY-AI site
Chapel Hill, North Carolina 27514
Chapel Hill, North Carolina 27514
Massive Bio SYNERGY-AI site
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Massive Bio SYNERGY-AI site
Fargo, North Dakota 58102
Fargo, North Dakota 58102
Massive Bio SYNERGY-AI site
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Massive Bio SYNERGY-AI site
Columbus, Ohio 43210
Columbus, Ohio 43210
Massive Bio SYNERGY-AI site
Mayfield Heights, Ohio 44124
Mayfield Heights, Ohio 44124
Massive Bio SYNERGY-AI site
Tulsa, Oklahoma 74146
Tulsa, Oklahoma 74146
Massive Bio SYNERGY-AI site
Portland, Oregon 97239
Portland, Oregon 97239
Massive Bio SYNERGY-AI site
Philadelphia, Pennsylvania 19044
Philadelphia, Pennsylvania 19044
Massive Bio SYNERGY-AI site
Providence, Rhode Island 02903
Providence, Rhode Island 02903
Massive Bio SYNERGY-AI site
Greenville, South Carolina 29605
Greenville, South Carolina 29605
Massive Bio SYNERGY-AI site
Memphis, Tennessee 38105
Memphis, Tennessee 38105
Massive Bio SYNERGY-AI site
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Massive Bio SYNERGY-AI site
Dallas, Texas 75246
Dallas, Texas 75246
Massive Bio SYNERGY-AI site
Houston, Texas 77030
Houston, Texas 77030
Massive Bio SYNERGY-AI site
Temple, Texas 76508
Temple, Texas 76508
Massive Bio SYNERGY-AI site
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
Massive Bio SYNERGY-AI site
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
Massive Bio SYNERGY-AI site
Seattle, Washington 98109
Seattle, Washington 98109
Massive Bio SYNERGY-AI site
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
Massive Bio SYNERGY-AI site
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
Massive Bio SYNERGY-AI site
San Juan, Puerto Rico 00917
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.