PREEMPT CRC: Prevention of Colorectal Cancer Through Multiomics Blood Testing
Sponsor
Freenome Holdings Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04369053
Collaborator
(none)
25,000
174
22.3
143.7
6.4
Study Details
Study Description
Brief Summary
The PREEMPT CRC study is a prospective multi-center observational study to validate a blood-based test for the early detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in blood to detect cancer early. The purpose of this prospective multi-center observational study is to validate a blood-based test for the detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
25000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prevention of Colorectal Cancer Through Multiomics Blood Testing
Actual Study Start Date
:
May 20, 2020
Anticipated Primary Completion Date
:
Mar 31, 2022
Anticipated Study Completion Date
:
Mar 31, 2022
Outcome Measures
Primary Outcome Measures
- Sensitivity for CRC of the Freenome test [90 days]
- Specificity of the Freenome test [90 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
45 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Key Inclusion Criteria
-
45-85 years of age
-
Willing to undergo a standard-of-care screening colonoscopy
-
Able and willing to provide a blood sample
-
Able and willing to sign informed consent
Key Exclusion Criteria
-
Known hereditary gastrointestinal cancer syndrome (for example, hereditary non-polyposis CRC syndrome (HNPCC) or Lynch syndrome, or familial adenomatous polyposis (FAP)
-
Personal history 2.1 CRC or colorectal adenoma 2.2 Inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and crohn's disease (CD) 2.3 Colonoscopy in the 9 years preceding enrollment 2.4 Stool DNA testing in the 2 years preceding enrollment 2.5 Symptoms of lower gastrointestinal tract disease warranting colonoscopic evaluation
-
A medical condition which, in the opinion of the Investigator, should preclude enrollment in the study
-
Participated or currently participating in a clinical research study in which an experimental medication has been administered during the 60 days up to and including the date of providing informed consent or may be administered through the time of the colonoscopy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pinnacle Research Group LLC | Anniston | Alabama | United States | 36207 |
| 2 | Birmingham VA Medical Center - Alabama | Birmingham | Alabama | United States | 35233 |
| 3 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
| 4 | Birmingham Gastroenterology Associates | Homewood | Alabama | United States | 35209 |
| 5 | Advanced Gastroenterology PC | Chandler | Arizona | United States | 85224 |
| 6 | Southeast Valley Gastro (SEVG) | Chandler | Arizona | United States | 85224 |
| 7 | Associated Gastroenterology Medical Group | Anaheim | California | United States | 92801 |
| 8 | Matrix Clinical Research | Beverly Hills | California | United States | 90212 |
| 9 | Precision Research Institute, LLC | Chula Vista | California | United States | 91910 |
| 10 | Citrus Valley Gastroenterology | Covina | California | United States | 91722 |
| 11 | Kaiser Permanente Southern California | Downey | California | United States | 90242 |
| 12 | Paragon Rx Clinical - Garden Grove | Garden Grove | California | United States | 92840 |
| 13 | Gastro Care Institute | Lancaster | California | United States | 93534 |
| 14 | Science 37 | Los Angeles | California | United States | 90094 |
| 15 | UCLA Medical Center | Los Angeles | California | United States | 90095 |
| 16 | St. Joseph Heritage Healthcare | Mission Viejo | California | United States | 92691 |
| 17 | Inland Empire GI | Murrieta | California | United States | 92562 |
| 18 | Los Angeles Gastroenterology Institute | Northridge | California | United States | 91325 |
| 19 | East Bay Center for Digestive Health | Oakland | California | United States | 94612 |
| 20 | Knowledge Research Center | Orange | California | United States | 92868 |
| 21 | Sutter Institute for Medical Research | Sacramento | California | United States | 95816 |
| 22 | University of California San Diego Medical Center | San Diego | California | United States | 92103 |
| 23 | Precision Research Institute, LLC | San Diego | California | United States | 92114 |
| 24 | UCSF Mount Zion Medical Center | San Francisco | California | United States | 94115 |
| 25 | Paragon Rx Clinical - Santa Ana | Santa Ana | California | United States | 92703 |
| 26 | Digestive Health Associates | Santa Monica | California | United States | 90404 |
| 27 | Kaiser Permanente Northern California | Walnut Creek | California | United States | 94596 |
| 28 | Clinical Research of California LLC | Walnut Creek | California | United States | 94598 |
| 29 | The Center for Gastrointestinal Medicine of Fairfield and Westchester, P.C | Greenwich | Connecticut | United States | 06831 |
| 30 | Naugatuck Valley GI Consultants | Prospect | Connecticut | United States | 06712 |
| 31 | Delaware Center for Digestive Care | Newark | Delaware | United States | 19713 |
| 32 | Veterans Affairs Medical Center | Washington | District of Columbia | United States | 20422 |
| 33 | Bay Pines VA Healthcare System | Bay Pines | Florida | United States | 33744 |
| 34 | Hillel Cohen, MD | Boca Raton | Florida | United States | 33433 |
| 35 | Universal Axon Clinical Research | Doral | Florida | United States | 33166 |
| 36 | Palmetto Research, LLC | Hialeah | Florida | United States | 33016 |
| 37 | The Center for Gastrointestinal Disorders | Hollywood | Florida | United States | 33021 |
| 38 | ENCORE | Jacksonville | Florida | United States | 32256 |
| 39 | IHS Health | Kissimmee | Florida | United States | 34741 |
| 40 | Central Florida Gastro Research | Kissimmee | Florida | United States | 34744 |
| 41 | Pharmax Research Clinic | Miami | Florida | United States | 33126 |
| 42 | Ocala GI Research | Ocala | Florida | United States | 34471 |
| 43 | St. Johns Center for Clinical Research | Saint Augustine | Florida | United States | 32086 |
| 44 | Florida Medical Clinic, LLC | Zephyrhills | Florida | United States | 33542 |
| 45 | Morehouse | Atlanta | Georgia | United States | 30310 |
| 46 | Metro Atlanta Gastroenterology, LLC | Atlanta | Georgia | United States | 30342 |
| 47 | Augusta University | Augusta | Georgia | United States | 30912 |
| 48 | IACT Health | Columbus | Georgia | United States | 31904 |
| 49 | Emory University School of Medicine | Conyers | Georgia | United States | 30322 |
| 50 | Gastroenterology Consultants of Augusta | Evans | Georgia | United States | 30809 |
| 51 | Gastrointestinal Specialists of Georgia | Marietta | Georgia | United States | 30060 |
| 52 | Pramukh Clinical Research | Roswell | Georgia | United States | 30076 |
| 53 | Gastroenterology Consultants of Savannah, PC | Savannah | Georgia | United States | 31405 |
| 54 | Southeast Georgia Gastroenterology, P.C. | Waycross | Georgia | United States | 31501 |
| 55 | University of Chicago | Chicago | Illinois | United States | 60637 |
| 56 | Digestive Health Services, a Division of GI Partners of Illinios | Downers Grove | Illinois | United States | 60515 |
| 57 | NorthShore University Health System | Evanston | Illinois | United States | 60201 |
| 58 | Edward Hines, Jr. VA Hospital | Hines | Illinois | United States | 60141 |
| 59 | Suburban Gastroenterology | Naperville | Illinois | United States | 60540 |
| 60 | Digestive Diseases Consultants of Kankakee | New Lenox | Illinois | United States | 60451 |
| 61 | GI Partners of Illinois - Southwest Gastroenerology | Oak Lawn | Illinois | United States | 60453 |
| 62 | Quincy Medical Group | Quincy | Illinois | United States | 62301 |
| 63 | Springfield Clinic, LLP | Springfield | Illinois | United States | 62702 |
| 64 | American Health Network of Indiana, LLC | Muncie | Indiana | United States | 47304 |
| 65 | Digestive Research Alliance of Michiana | South Bend | Indiana | United States | 46635 |
| 66 | University of Kansas Medical Center Research Institute, Inc. | Kansas City | Kansas | United States | 66160 |
| 67 | Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka | Kansas | United States | 66606 |
| 68 | Kansas Gastroenterology, LLC | Wichita | Kansas | United States | 67226 |
| 69 | Tri-State Gastroenterology Associates, PSC | Crestview Hills | Kentucky | United States | 41017 |
| 70 | Delta Research Partners - Bastrop | Bastrop | Louisiana | United States | 71220 |
| 71 | Northlake Gastroenterology Associates | Hammond | Louisiana | United States | 70403 |
| 72 | Delta Research Parnters - Monroe | Monroe | Louisiana | United States | 71201 |
| 73 | Ochsner Clinic Foundation | New Orleans | Louisiana | United States | 70115 |
| 74 | Louisiana Research Center, LLC | Shreveport | Louisiana | United States | 71105 |
| 75 | Woodholme Gastroenterology Associates | Baltimore | Maryland | United States | 21208 |
| 76 | Chevy Chase Clinical Research | Chevy Chase | Maryland | United States | 20815 |
| 77 | Gastro Center of Maryland | Columbia | Maryland | United States | 21045 |
| 78 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 79 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 80 | Greater Boston Gastroenterology | Framingham | Massachusetts | United States | 01702 |
| 81 | South Suburban Gastroenterology | South Weymouth | Massachusetts | United States | 02190 |
| 82 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
| 83 | Gastroenterology Associates of Mississippi | Columbus | Mississippi | United States | 39705 |
| 84 | Gastrointestinal Associates | Flowood | Mississippi | United States | 39232 |
| 85 | Gastrointestinal Associates | Columbia | Missouri | United States | 65201 |
| 86 | Kansas City VA Medical Center | Kansas City | Missouri | United States | 64128 |
| 87 | Mercy Washington | Washington | Missouri | United States | 63090 |
| 88 | LV Gastroenterology Associates | Las Vegas | Nevada | United States | 89113 |
| 89 | VA Southern Nevada | North Las Vegas | Nevada | United States | 89086 |
| 90 | VA Sierra Nevada | Reno | Nevada | United States | 89502 |
| 91 | Advanced Research Institute | Reno | Nevada | United States | 89511 |
| 92 | Gastroenterology Associates in NJ | Dover | New Jersey | United States | 07801 |
| 93 | AIG Digestive Disease Research | Florham Park | New Jersey | United States | 07932 |
| 94 | Digestive Healthcare Center | Hillsborough | New Jersey | United States | 08844 |
| 95 | Gastroenterology Medical Associates | North Bergen | New Jersey | United States | 07047 |
| 96 | Dr. Howard N. Guss and Dr. Gagan Beri | Ocean City | New Jersey | United States | 07712 |
| 97 | Princeton GI Associates | Princeton | New Jersey | United States | 08540 |
| 98 | Teaneck Gastroenterology Associates | Teaneck | New Jersey | United States | 07666 |
| 99 | Ocean Family Gastroenterology | Toms River | New Jersey | United States | 08755 |
| 100 | Advanced Gasteroenterology Group | Union | New Jersey | United States | 07083 |
| 101 | Center for Digestive Diseases | Union | New Jersey | United States | 07083 |
| 102 | Samuel S. Stratton VA Medical Center | Albany | New York | United States | 12208 |
| 103 | Sam Moskowitz, MD | Brooklyn | New York | United States | 11234 |
| 104 | Associated Gastroenterologists of Central NY | Camillus | New York | United States | 13031 |
| 105 | North Shore Gastroenterology Associates | Great Neck | New York | United States | 11023 |
| 106 | South Island Gastro | Lawrence | New York | United States | 11559 |
| 107 | Mark Coronel, MD | Manorville | New York | United States | 11949 |
| 108 | Gastrointestinal Associates of Rockland | New City | New York | United States | 10956 |
| 109 | Mid Hudson Medical Research, PLLC | New Windsor | New York | United States | 12553 |
| 110 | NYU Grossman School of Medicine | New York | New York | United States | 10016 |
| 111 | Icahn School of Medicine at Mount Sinai | New York | New York | United States | 10029 |
| 112 | Cornell | New York | New York | United States | 10065 |
| 113 | Syracuse Gastroenterological Associates, PC | Syracuse | New York | United States | 13210 |
| 114 | GastroCare LI | Valley Stream | New York | United States | 11581 |
| 115 | Long Island Gastrointestinal Specialist | Wantagh | New York | United States | 11793 |
| 116 | William S. Silver MD & Eric L. Tatar MD PC. | West Nyack | New York | United States | 10994 |
| 117 | Cary Gastro Associates | Cary | North Carolina | United States | 27518 |
| 118 | University of North Carolina | Chapel Hill | North Carolina | United States | 27599 |
| 119 | Duke Clinic | Durham | North Carolina | United States | 27710 |
| 120 | Carolina's GI Research, LLC | Raleigh | North Carolina | United States | 27607 |
| 121 | PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina | United States | 27103 |
| 122 | Trinity Health Center Medical Arts | Minot | North Dakota | United States | 58701 |
| 123 | Cincinnati GI | Cincinnati | Ohio | United States | 45255 |
| 124 | Cleveland Clinic Foundation - Central | Cleveland | Ohio | United States | 44195 |
| 125 | The Ohio State University Wexner Medical Center | Columbus | Ohio | United States | 43210 |
| 126 | Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | United States | 44060 |
| 127 | DSI Research | Springboro | Ohio | United States | 45066 |
| 128 | Summit Medical Group Oregon - BMC | Bend | Oregon | United States | 97701 |
| 129 | Oregon Health & Science University | Portland | Oregon | United States | 97201 |
| 130 | The Oregon Clinic, P.C. | Portland | Oregon | United States | 97220 |
| 131 | Eastern Pennsylvania GI & Liver Specialist | Allentown | Pennsylvania | United States | 18104 |
| 132 | Blair Gastroenterology Associates | Altoona | Pennsylvania | United States | 16602 |
| 133 | Valley Gastroenterology Associates | Beaver Falls | Pennsylvania | United States | 15010 |
| 134 | Susquehanna Research Group, LLC | Camp Hill | Pennsylvania | United States | 17011 |
| 135 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19014 |
| 136 | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 137 | UPMC Digestive Diseases Center GAS | Pittsburgh | Pennsylvania | United States | 15213 |
| 138 | Southeast Medical Research II, LLC | Charleston | South Carolina | United States | 29406 |
| 139 | Gastroenterology Associates, PA | Greenville | South Carolina | United States | 29601 |
| 140 | Digestive Disease Research Center | Greenwood | South Carolina | United States | 29646 |
| 141 | Consultants in GI | West Columbia | South Carolina | United States | 29169 |
| 142 | ARCare Center of Clinical Research | Franklin | Tennessee | United States | 37067 |
| 143 | Gastrointestinal Associates of NorthEast Tenn | Johnson City | Tennessee | United States | 37604 |
| 144 | Tri-Cities Gastroenterology | Kingsport | Tennessee | United States | 37663 |
| 145 | Gastroenterology Associates, PC | Knoxville | Tennessee | United States | 37909 |
| 146 | Meharry Medical College | Nashville | Tennessee | United States | 37208 |
| 147 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
| 148 | Advanced Gastroenterology | Union City | Tennessee | United States | 38261 |
| 149 | Texas Oncology | Amarillo | Texas | United States | 79106 |
| 150 | Gastroenterology Practice Associates | Arlington | Texas | United States | 76018 |
| 151 | Mohan, Uma Yanamadala | Cypress | Texas | United States | 77429 |
| 152 | University of Texas Southwestern Medical Center | Dallas | Texas | United States | 75390 |
| 153 | Ertan Digestive Disease Center | Houston | Texas | United States | 77030 |
| 154 | University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 155 | Gastroenterology Consults | Houston | Texas | United States | 77034 |
| 156 | Hope Digestive and Liver Disease Clinic of Houston | Houston | Texas | United States | 77070 |
| 157 | Panamericana Family Medicine Clinic | Houston | Texas | United States | 77080 |
| 158 | Rio Grande Gastroenterology | McAllen | Texas | United States | 78503 |
| 159 | Gastroenterology Consultants | Pasadena | Texas | United States | 77504 |
| 160 | Digestive System Healthcare | Pasadena | Texas | United States | 77505 |
| 161 | Gastroenterology Partners of North Houston | Shenandoah | Texas | United States | 77384 |
| 162 | Texas Gastro Consultants | Tomball | Texas | United States | 77375 |
| 163 | Texas Oncology | Tyler | Texas | United States | 75702 |
| 164 | University of Texas Health Science Center at Tyler | Tyler | Texas | United States | 75708 |
| 165 | Digestive Health Research of North Texas | Wichita Falls | Texas | United States | 76301 |
| 166 | Advanced Research Institute | Ogden | Utah | United States | 84405 |
| 167 | Intermountain | Salt Lake City | Utah | United States | 84119 |
| 168 | Digestive and Liver Disease Specialists, Ltd. | Norfolk | Virginia | United States | 23502 |
| 169 | Gastroenterology Consultants of SW Virginia | Roanoke | Virginia | United States | 24014 |
| 170 | UW Medical Center | Seattle | Washington | United States | 98195 |
| 171 | Washington Gastroenterology - Tacoma Clinic | Tacoma | Washington | United States | 98405 |
| 172 | GastroIntestinal Associates, S.C. | Wausau | Wisconsin | United States | 54401 |
| 173 | Gastroenterology Associates of Wyoming | Casper | Wyoming | United States | 82601 |
| 174 | Cleveland Clinic Abu Dhabi | Abu Dhabi | United Arab Emirates |
Sponsors and Collaborators
- Freenome Holdings Inc.
Investigators
- Principal Investigator: Girish Putcha, MD PhD, Freenome Holdings Inc.
- Principal Investigator: Aasma Shaukat, MD MPH, University of Minnesota
- Principal Investigator: Theodore R Levin, MD, The Permanente Medical Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Freenome Holdings Inc.
ClinicalTrials.gov Identifier:
NCT04369053
Other Study ID Numbers:
- FRNM-004
First Posted:
Apr 30, 2020
Last Update Posted:
Mar 11, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Freenome Holdings Inc.
Additional relevant MeSH terms: