ClinicalTrials.gov record
Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"
ClinicalTrials.gov ID: NCT04144738
Public ClinicalTrials.gov record NCT04144738. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to assess the sensitivity for colorectal cancer (CRC) and specificity of the mt-sDNA 2.0 test.
Study identification
- NCT ID
- NCT04144738
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 26,758 participants
Conditions and interventions
Conditions
Interventions
- mt-sDNA 2.0 screening test Diagnostic Test
- FIT test Diagnostic Test
- Colonoscopy Procedure
Diagnostic Test · Procedure
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 15, 2019 (Actual)
- Primary completion
- Mar 30, 2023 (Actual)
- Completion
- Mar 30, 2023 (Actual)
- Last update posted
- Sep 1, 2023
2019 – 2023
United States locations
- U.S. sites
- 195
- U.S. states
- 39
- U.S. cities
- 164
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Parkway Medical Center | Birmingham | Alabama | 35215 | — |
| Summit Internal Medicine, PC | Birmingham | Alabama | 35243 | — |
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Cullman Clinical Trials | Cullman | Alabama | 35055 | — |
| Digestive Health Specialists of the Southeast | Dothan | Alabama | 36301 | — |
| G & L Research | Foley | Alabama | 36535 | — |
| Medical Affiliated Research Center | Huntsville | Alabama | 35801 | — |
| East View Medical Research, LLC | Mobile | Alabama | 36608 | — |
| GI Associates of West Alabama, P.C | Tuscaloosa | Alabama | 35406 | — |
| Mayo Clinic - AZ | Phoenix | Arizona | 85054 | — |
| Del Sol Research Management, LLC | Tucson | Arizona | 85712 | — |
| Southern Arizona VA Health Care System (SAVAHCS) | Tucson | Arizona | 85723 | — |
| Lynn Institute of the Ozarks | Little Rock | Arkansas | 72204 | — |
| Applied Research Center of Arkansas | Little Rock | Arkansas | 72212 | — |
| Arkansas Gastroenterology, P.A. | North Little Rock | Arkansas | 72117 | — |
| Fomat Medical Research | Camarillo | California | 93012 | — |
| Alliance Research Institute | Canoga Park | California | 91304 | — |
| GW Research Inc | Chula Vista | California | 91910 | — |
| Paragon Rx Clinical, Inc. | Garden Grove | California | 92840 | — |
| United Medical Doctors | Irvine | California | 92618 | — |
| Prime Care Clinical Research Center | Laguna Hills | California | 92656 | — |
| Gastro Care Institute | Lancaster | California | 93534 | — |
| Facey Medical Foundation | Mission Hills | California | 91345 | — |
| Knowledge Research Center | Orange | California | 92868 | — |
| Desert Oasis Healthcare Medical Group | Palm Springs | California | 92262 | — |
| Palo Alto Veterans Institute for Research | Palo Alto | California | 34304 | — |
| SDG Clinical Research | San Diego | California | 92103 | — |
| San Jose Gastroenterology | San Jose | California | 95116 | — |
| Paragon Rx Clinical, Inc. - Santa Ana | Santa Ana | California | 92703 | — |
| Sansum Clinic | Santa Barbara | California | 93105 | — |
| Unison Clinical Trials | Sherman Oaks | California | 91403 | — |
| Millennium Clinical Trials | Thousand Oaks | California | 91360 | — |
| Dream Team Clinical Research | Upland | California | 91786 | — |
| New West Physicians | Golden | Colorado | 80401 | — |
| Gastroenterology Associates of Fairfield County | Bridgeport | Connecticut | 06606 | — |
| Bridgeport Hospital | Bridgeport | Connecticut | 06610 | — |
| Connecticut Clinical Research Institute | Bristol | Connecticut | 06010 | — |
| Yale University | New Haven | Connecticut | 06519 | — |
| Cornerstone Research Institute | Altamonte Springs | Florida | 32701 | — |
| Vanguard Clinical Research | Fort Myers | Florida | 33907 | — |
| SIMED Health Research | Gainesville | Florida | 32607 | — |
| Westside Center of Clinical Research | Jacksonville | Florida | 32205 | — |
| Shands Jacksonville Medical Center, Inc - University of Florida Health | Jacksonville | Florida | 32206 | — |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | — |
| Wr-Msra, Llc | Lake City | Florida | 32055 | — |
| Pioneer Clinical Research | Lighthouse PT | Florida | 33064 | — |
| Suncoast Research Group, LLC | Miami | Florida | 33135 | — |
| Next Phase Research Alliance | Miami | Florida | 33144 | — |
| Research Associates of South Florida, LLC | Miami | Florida | 33156 | — |
| Gastro Health Research | Miami | Florida | 33176 | — |
| Gastroenterology Group of Naples | Naples | Florida | 34102 | — |
| Sarkis Clinical Trials | Ocala | Florida | 34471 | — |
| Imic, Inc. | Palmetto Bay | Florida | 33157 | — |
| Family Medical Specialists of Florida, PLC | Plant City | Florida | 33563 | — |
| Alternative Solutions, LLC | St. Petersburg | Florida | 33711 | — |
| Precision Clinical Research, LLC | Sunrise | Florida | 33351 | — |
| Clinical Trials of Tampa | Tampa | Florida | 33614 | — |
| Summit Clinical Research, LLC | Athens | Georgia | 30607 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| Atlanta Center for Gastroenterology, P.C. | Decatur | Georgia | 30033 | — |
| Infinite Clinical Trials | Morrow | Georgia | 30260 | — |
| Grand Teton Research Group | Idaho Falls | Idaho | 83404 | — |
| Christie Clinic, LLC | Champaign | Illinois | 61882 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| GI Partners of IL / Avicenna | Downers Grove | Illinois | 60515 | — |
| Edward Hines Jr. VA Hospital | Hines | Illinois | 60141 | — |
| Southwest Gastroenterology | Oak Lawn | Illinois | 60453 | — |
| Margaret Mary Health | Batesville | Indiana | 47006 | — |
| Deaconess Clinic, Inc. | Evansville | Indiana | 47713 | — |
| Richard L. Roudebush VA Medical Center | Indianapolis | Indiana | 46202 | — |
| Deaconess Clinic, Inc. | Newburgh | Indiana | 47630 | — |
| The South Bend Clinic | South Bend | Indiana | 46617 | — |
| PMG Research | Ames | Iowa | 50010 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| The Iowa Clinic, P.C. | West Des Moines | Iowa | 50266 | — |
| Digestive Health Center of the Four States, LLC | Galena | Kansas | 66739 | — |
| Hutchinson Clinic | Hutchinson | Kansas | 67502 | — |
| Ascension Via Christi Hospitals Wichita, Inc | Wichita | Kansas | 67214 | — |
| St. Elizabeth Healthcare | Edgewood | Kentucky | 41017 | — |
| Horizon Research Group of Opelousas, LLC | Eunice | Louisiana | 70535 | — |
| Houma Digestive Health Specialists-CroNOLA | Houma | Louisiana | 70360 | — |
| Combined Gastro Research, LLC | Lafayette | Louisiana | 70503 | — |
| Clinical Trials of SWLA, LLC | Lake Charles | Louisiana | 70601 | — |
| Clinical Trials Management, LLC | Metairie | Louisiana | 70006 | — |
| New Orleans Research Institute | Metairie | Louisiana | 70006 | — |
| Delta Research Partners | Monroe | Louisiana | 71201 | — |
| Louisiana Research Center; Gastrointestinal Associates | Shreveport | Louisiana | 71105 | — |
| Clinical Trials of America, LLC | West Monroe | Louisiana | 71291 | — |
| Gastro Health Research | Annapolis | Maryland | 21401 | — |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | — |
| Centennial Medical Group | Elkridge | Maryland | 21075 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center - Harvard | Boston | Massachusetts | 02215 | — |
| IQVIA RDS, Inc. | Cambridge | Massachusetts | 02139 | — |
| Digestive Health Specialists, PC | Chelmsford | Massachusetts | 01824 | — |
| NECCR PrimaCare Research, LLC | Fall River | Massachusetts | 02721 | — |
| University of Massachusetts - Worcester | Worcester | Massachusetts | 01655 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Oakland Medical Research | Troy | Michigan | 48085 | — |
| Clinical Research Institute of Michigan, LLC | Troy | Michigan | 48098 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Southern Therapy and Advanced Research LLC (STAR) | Jackson | Mississippi | 39216 | — |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | — |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | — |
| Methodist Physicians Clinic / CCT Research | Fremont | Nebraska | 68025 | — |
| CHI Nebraska | Omaha | Nebraska | 68124 | — |
| University of Nevada, Las Vegas | Las Vegas | Nevada | 89102 | — |
| Clinical Research of South Nevada | Las Vegas | Nevada | 89121 | — |
| Digestive Health Associates | Reno | Nevada | 89511 | — |
| AGA Clinical Research Associates, LLC | Egg Harbor | New Jersey | 08234 | — |
| Allied Health Clinical Research Organization, LLC | West Long Branch | New Jersey | 07728 | — |
| United Health Services Hospitals, Inc. | Binghamton | New York | 13903 | — |
| VA NY Harbor HCS- Brooklyn Campus | Brooklyn | New York | 11209 | — |
| Sing Chan, MD | Flushing | New York | 11354 | — |
| Mid Hudson Medical Research, PLLC | New Windsor | New York | 12553 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| DiGiovanna Institute for Medical Education & Research | North Massapequa | New York | 11758 | — |
| Digestive Health Partners, PA | Asheville | North Carolina | 28801 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Atrium Health Department of Family Medicine Research | Charlotte | North Carolina | 28207 | — |
| Javara | Charlotte | North Carolina | 28210 | — |
| Coastal Research Institute, LLC | Fayetteville | North Carolina | 28304 | — |
| Medication Management LLC | Greensboro | North Carolina | 27405 | — |
| Peters Medical Research | High Point | North Carolina | 27262 | — |
| Clinical Trials of America, LLC | Mount Airy | North Carolina | 27030 | — |
| Coastal Carolina Health Care, P.A. | New Bern | North Carolina | 28562 | — |
| Trial Management Associates, LLC | Wilmington | North Carolina | 28403 | — |
| Lillestol Research, LLC | Fargo | North Dakota | 58104 | — |
| Plains Clinical Research Center, LLC | Fargo | North Dakota | 58104 | — |
| Great Lakes Medical Research, LLC | Beachwood | Ohio | 44122 | — |
| Gastro Health Research | Cincinnati | Ohio | 45219 | — |
| Hightop Medical Research Clinic | Cincinnati | Ohio | 45224 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Dayton Clinical Resesarch | Dayton | Ohio | 45409 | — |
| META Medical Research Institute, LLC | Dayton | Ohio | 45432 | — |
| Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | 44060 | — |
| Paramount Medical Research and Consulting, LLC | Middleburg Heights | Ohio | 44130 | — |
| Northshore Gastroenterology Research, LLC | Westlake | Ohio | 44145 | — |
| Comprehensive Internal Medicine, Inc | Wooster | Ohio | 44691 | — |
| Alliance for Multispecialty Research, LLC | Norman | Oklahoma | 73069 | — |
| SSM Health Medical Group/Hightower Clinical | Oklahoma City | Oklahoma | 73102 | — |
| Options Health Research, LLC | Tulsa | Oklahoma | 74104 | — |
| Great Lakes Medical Research, LLC | Harrisburg | Pennsylvania | 17110 | — |
| Richard M. Kastelic, M.D., and Associates, P.C. | Johnstown | Pennsylvania | 15905 | — |
| Regional GI | Lancaster | Pennsylvania | 17601 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Care Access Research, Pottsville | Pottsville | Pennsylvania | 17901 | — |
| Ralph H. Johnson VAMC | Charleston | South Carolina | 29401 | — |
| Pharmacorp Clinical Trials, Inc. | Charleston | South Carolina | 29412 | — |
| Invocare Medical Research & Healthcare Center | West Columbia | South Carolina | 29169 | — |
| Rapid City Medical Center, LLP | Rapid City | South Dakota | 57701 | — |
| WR-ClinSearch, LLC | Chattanooga | Tennessee | 37421 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| The Jackson Clinic, PA | Jackson | Tennessee | 38301 | — |
| Clinical Research Solutions, LLC - TN | Jackson | Tennessee | 38305 | — |
| The Jackson Clinic, PA | Jackson | Tennessee | 38305 | — |
| Tri-Cities | Kingsport | Tennessee | 37663 | — |
| Great Lakes Medical Research, LLC | Union City | Tennessee | 38261 | — |
| ARC Clinical Research at Four Points | Austin | Texas | 78726 | — |
| Elligo Health Research Inc. | Austin | Texas | 78738 | — |
| ARC Clinical Research at William Cannon | Austin | Texas | 78745 | — |
| Avant Research Associates | Austin | Texas | 78748 | — |
| Mercy Family Clinic | Dallas | Texas | 75211 | — |
| Dharma PA D/B/A Southwest Family Medicine Associates | Dallas | Texas | 75235 | — |
| Texas Tech University Health Sciences Center El Paso | El Paso | Texas | 79905 | — |
| Houston Digestive Disease | Houston | Texas | 77030 | — |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Biopharma Informatic, LLC | Houston | Texas | 77084 | — |
| Fairway Medical Clinic | Houston | Texas | 77087 | — |
| Digestive System Healthcare | Houston | Texas | 77505 | — |
| FMC Science, LLC | Lampasas | Texas | 76550 | — |
| Rio Grande Gastroenterology | McAllen | Texas | 78503 | — |
| Wellness Clinical Research | McKinney | Texas | 75071 | — |
| ARC Clinical Research at Kelly Lane | Pflugerville | Texas | 78660 | — |
| Epic Medical Research, LLC | Red Oak | Texas | 75154 | — |
| Clinical Associates in Research Therapeutics of America | San Antonio | Texas | 78212 | — |
| Gastroenterology Research of San Antonio | San Antonio | Texas | 78229 | — |
| Texas Gastro Consultants | Tomball | Texas | 77375 | — |
| Progressive Clinical Research, LLC | Bountiful | Utah | 84010 | — |
| Tanner Clinic | Layton | Utah | 84041 | — |
| Advanced Research Institute | Ogden | Utah | 84405 | — |
| Advanced Clinical Research | Riverton | Utah | 84065 | — |
| Granger Medical Clinic | Riverton | Utah | 84096 | — |
| Advanced Research Institute | Sandy City | Utah | 84092 | — |
| Blue Ridge Medical Research | Lynchburg | Virginia | 24502 | — |
| Summit Clinical Research | Petersburg | Virginia | 23805 | — |
| Central Virginia VA Healthcare System | Richmond | Virginia | 23249 | — |
| Virginia Gastroenterology Institute | Suffolk | Virginia | 23434 | — |
| Benaroya Research Institute at Virginia Mason | Seattle | Washington | 98101 | — |
| Spokane Gastroenterology | Spokane | Washington | 99202 | — |
| Wenatchee Valley Hospital | Wenatchee | Washington | 98801 | — |
| University Physicians and Surgeons, Inc. DBA Marshall Health | Huntington | West Virginia | 25701 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53215 | — |
| Ascension Wisconsin | Milwaukee | Wisconsin | 53211 | — |
| Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04144738, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 1, 2023 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04144738 live on ClinicalTrials.gov.