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 4049979, Alabama 4829764 35294
Birmingham 4049979, Alabama 4829764 35294
Massive Bio SYNERGY-AI site
Mobile 4076598, Alabama 4829764 36604
Mobile 4076598, Alabama 4829764 36604
Massive Bio SYNERGY-AI site
Scottsdale 5313457, Arizona 5551752 85260
Scottsdale 5313457, Arizona 5551752 85260
Massive Bio SYNERGY-AI site
Little Rock 4119403, Arkansas 4099753 72205
Little Rock 4119403, Arkansas 4099753 72205
Massive Bio SYNERGY-AI site
Duarte 5344147, California 5332921 91010
Duarte 5344147, California 5332921 91010
Massive Bio SYNERGY-AI site
Irvine 5359777, California 5332921 92618
Irvine 5359777, California 5332921 92618
Massive Bio SYNERGY-AI site
La Jolla 5363943, California 5332921 92093
La Jolla 5363943, California 5332921 92093
Massive Bio SYNERGY-AI site
Orange 5379513, California 5332921 92868
Orange 5379513, California 5332921 92868
Massive Bio SYNERGY-AI site
San Francisco 5391959, California 5332921 94143
San Francisco 5391959, California 5332921 94143
Massive Bio SYNERGY-AI site
Stanford 5398563, California 5332921 94305
Stanford 5398563, California 5332921 94305
Massive Bio SYNERGY-AI site
Aurora 5412347, Colorado 5417618 80045
Aurora 5412347, Colorado 5417618 80045
Massive Bio SYNERGY-AI site
Denver 5419384, Colorado 5417618 80218
Denver 5419384, Colorado 5417618 80218
Massive Bio SYNERGY-AI site
Littleton 5429032, Colorado 5417618 80129
Littleton 5429032, Colorado 5417618 80129
Massive Bio SYNERGY-AI site
Hartford 4835797, Connecticut 4831725 06102
Hartford 4835797, Connecticut 4831725 06102
Massive Bio SYNERGY-AI site
Norwalk 4839822, Connecticut 4831725 06856
Norwalk 4839822, Connecticut 4831725 06856
Massive Bio SYNERGY-AI site
Newark 4143861, Delaware 4142224 19713
Newark 4143861, Delaware 4142224 19713
Massive Bio SYNERGY-AI site
Jacksonville 4160021, Florida 4155751 32224
Jacksonville 4160021, Florida 4155751 32224
Massive Bio SYNERGY-AI site
Miami 4164138, Florida 4155751 33136
Miami 4164138, Florida 4155751 33136
Massive Bio SYNERGY-AI site
Tampa 4174757, Florida 4155751 33612
Tampa 4174757, Florida 4155751 33612
Massive Bio SYNERGY-AI site
Atlanta 4180439, Georgia 4197000 30322
Atlanta 4180439, Georgia 4197000 30322
Massive Bio SYNERGY-AI site
Savannah 4221552, Georgia 4197000 31405
Savannah 4221552, Georgia 4197000 31405
Massive Bio SYNERGY-AI site
Boise 5586437, Idaho 5596512 83706
Boise 5586437, Idaho 5596512 83706
Massive Bio SYNERGY-AI site
Chicago 4887398, Illinois 4896861 60611
Chicago 4887398, Illinois 4896861 60611
Massive Bio SYNERGY-AI site
Iowa City 4862034, Iowa 4862182 52242
Iowa City 4862034, Iowa 4862182 52242
Massive Bio SYNERGY-AI site
New Orleans 4335045, Louisiana 4331987 70112
New Orleans 4335045, Louisiana 4331987 70112
Massive Bio SYNERGY-AI site
Scarborough 4977882, Maine 4971068 04074
Scarborough 4977882, Maine 4971068 04074
Massive Bio SYNERGY-AI site
Baltimore 4347778, Maryland 4361885 21218
Baltimore 4347778, Maryland 4361885 21218
Massive Bio SYNERGY-AI site
Bethesda 4348599, Maryland 4361885 20892
Bethesda 4348599, Maryland 4361885 20892
Massive Bio SYNERGY-AI site
Silver Spring 4369596, Maryland 4361885 20904
Silver Spring 4369596, Maryland 4361885 20904
Massive Bio SYNERGY-AI site
Towson 4371582, Maryland 4361885 21204
Towson 4371582, Maryland 4361885 21204
Massive Bio SYNERGY-AI site
Worcester 4956184, Massachusetts 6254926 01655
Worcester 4956184, Massachusetts 6254926 01655
Massive Bio SYNERGY-AI site
Ann Arbor 4984247, Michigan 5001836 48109
Ann Arbor 4984247, Michigan 5001836 48109
Massive Bio SYNERGY-AI site
Lansing 4998830, Michigan 5001836 48912
Lansing 4998830, Michigan 5001836 48912
Massive Bio SYNERGY-AI site
Duluth 5024719, Minnesota 5037779 55805
Duluth 5024719, Minnesota 5037779 55805
Massive Bio SYNERGY-AI site
Hattiesburg 4429295, Mississippi 4436296 39401
Hattiesburg 4429295, Mississippi 4436296 39401
Massive Bio SYNERGY-AI site
Kansas City 4393217, Missouri 4398678 64111
Kansas City 4393217, Missouri 4398678 64111
Massive Bio SYNERGY-AI site
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
Massive Bio SYNERGY-AI site
Billings 5640350, Montana 5667009 59102
Billings 5640350, Montana 5667009 59102
Massive Bio SYNERGY-AI site
Omaha 5074472, Nebraska 5073708 68124
Omaha 5074472, Nebraska 5073708 68124
Massive Bio SYNERGY-AI site
New Brunswick 5101717, New Jersey 5101760 08901
New Brunswick 5101717, New Jersey 5101760 08901
Massive Bio SYNERGY-AI site
Albuquerque 5454711, New Mexico 5481136 87131
Albuquerque 5454711, New Mexico 5481136 87131
Massive Bio SYNERGY-AI site
Buffalo 5110629, New York 5128638 14263
Buffalo 5110629, New York 5128638 14263
Massive Bio SYNERGY-AI site
Hempstead 5120478, New York 5128638 11042
Hempstead 5120478, New York 5128638 11042
Massive Bio SYNERGY-AI site
Manhasset 5125766, New York 5128638 11030
Manhasset 5125766, New York 5128638 11030
Massive Bio SYNERGY-AI site
New York 5128581, New York 5128638 10006
New York 5128581, New York 5128638 10006
Massive Bio SYNERGY-AI site
Staten Island 5139568, New York 5128638 10314
Staten Island 5139568, New York 5128638 10314
Massive Bio SYNERGY-AI site
Chapel Hill 4460162, North Carolina 4482348 27514
Chapel Hill 4460162, North Carolina 4482348 27514
Massive Bio SYNERGY-AI site
Winston-Salem 4499612, North Carolina 4482348 27157
Winston-Salem 4499612, North Carolina 4482348 27157
Massive Bio SYNERGY-AI site
Fargo 5059163, North Dakota 5690763 58102
Fargo 5059163, North Dakota 5690763 58102
Massive Bio SYNERGY-AI site
Cincinnati 4508722, Ohio 5165418 45219
Cincinnati 4508722, Ohio 5165418 45219
Massive Bio SYNERGY-AI site
Columbus 4509177, Ohio 5165418 43210
Columbus 4509177, Ohio 5165418 43210
Massive Bio SYNERGY-AI site
Mayfield Heights 5162188, Ohio 5165418 44124
Mayfield Heights 5162188, Ohio 5165418 44124
Massive Bio SYNERGY-AI site
Tulsa 4553433, Oklahoma 4544379 74146
Tulsa 4553433, Oklahoma 4544379 74146
Massive Bio SYNERGY-AI site
Portland 5746545, Oregon 5744337 97239
Portland 5746545, Oregon 5744337 97239
Massive Bio SYNERGY-AI site
Philadelphia 4560349, Pennsylvania 6254927 19044
Philadelphia 4560349, Pennsylvania 6254927 19044
Massive Bio SYNERGY-AI site
Providence 5224151, Rhode Island 5224323 02903
Providence 5224151, Rhode Island 5224323 02903
Massive Bio SYNERGY-AI site
Greenville 4580543, South Carolina 4597040 29605
Greenville 4580543, South Carolina 4597040 29605
Massive Bio SYNERGY-AI site
Memphis 4641239, Tennessee 4662168 38105
Memphis 4641239, Tennessee 4662168 38105
Massive Bio SYNERGY-AI site
Nashville 4644585, Tennessee 4662168 37203
Nashville 4644585, Tennessee 4662168 37203
Massive Bio SYNERGY-AI site
Dallas 4684888, Texas 4736286 75246
Dallas 4684888, Texas 4736286 75246
Massive Bio SYNERGY-AI site
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Massive Bio SYNERGY-AI site
Temple 4735966, Texas 4736286 76508
Temple 4735966, Texas 4736286 76508
Massive Bio SYNERGY-AI site
Salt Lake City 5780993, Utah 5549030 84112
Salt Lake City 5780993, Utah 5549030 84112
Massive Bio SYNERGY-AI site
Charlottesville 4752031, Virginia 6254928 22908
Charlottesville 4752031, Virginia 6254928 22908
Massive Bio SYNERGY-AI site
Seattle 5809844, Washington 5815135 98109
Seattle 5809844, Washington 5815135 98109
Massive Bio SYNERGY-AI site
Morgantown 4815352, West Virginia 4826850 26506
Morgantown 4815352, West Virginia 4826850 26506
Massive Bio SYNERGY-AI site
Milwaukee 5263045, Wisconsin 5279468 53226
Milwaukee 5263045, Wisconsin 5279468 53226
Massive Bio SYNERGY-AI site
San Juan 4568127, Puerto Rico 00917
San Juan 4568127, 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.