Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"
Study Details
Study Description
Brief Summary
The primary objective of this study is to assess the sensitivity for colorectal cancer (CRC) and specificity of the mt-sDNA 2.0 test.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
Subjects 40 years of age and older scheduled for a screening colonoscopy will be enrolled. Subject will complete the mt-sDNA 2.0 test and the commercially available FIT, followed by completion of a screening colonoscopy. The results of the mt-sDNA screening test and FIT will not be provided to investigators for clinical management of the study subject. Personnel performing the colonoscopy and producing the resulting report and personnel performing histopathologial review of reports or tissue (if applicable) will remain blinded to the results of the mt-sDNA 2.0 screening test results.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Individuals eligible for CRC Screening Individuals who are 40 years of age and older, eligible for CRC screening, and scheduled for a screening colonoscopy. |
Diagnostic Test: mt-sDNA 2.0 screening test
Stool samples will be collected by the subject for the mt-sDNA screening test.
Diagnostic Test: FIT test
Stool samples will be collected by the subject for the FIT test.
Procedure: Colonoscopy
Subjects will undergo a screening colonoscopy.
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Outcome Measures
Primary Outcome Measures
- Sensitivity for CRC with the mt-sDNA 2.0 test [Through study completion, an average of 180 days]
- Specificity with the mt-sDNA 2.0 test [Through study completion, an average of 180 days]
Secondary Outcome Measures
- Sensitivity for advanced precancerous lesions [Through study completion, an average of 180 days]
- Sensitivity for CRC compared to a commercially available fecal immunochemical test (FIT) [Through study completion, an average of 180 days]
- Sensitivity for advanced precancerous lesions compared to commercially available fecal immunochemical test (FIT). [Through study completion, an average of 180 days]
- Specificity for no colorectal neoplastic findings [Through study completion, an average of 180 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects must meet the following criteria to be eligible for the study:
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Subject is ≥ 40 years of age at the time of enrollment.
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Subject presents for a screening colonoscopy per standard of care.
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Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
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Subject is able and willing to sign informed consent
Exclusion Criteria:
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Subject has a history of CRC or advanced precancerous lesions.
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Subject has a diagnosis or medical / family history of any of the following conditions, including:
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Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome),
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Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome"),
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Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis.
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Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.
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Subject has a diagnosis of Cronkhite-Canada Syndrome.
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Subject has had a positive Cologuard within the previous 2 years, or fecal occult blood test or FIT within the previous 6 months.
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Subject has undergone a colonoscopy within the previous 9 years with the exception of a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention.
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Subject has had overt rectal bleeding within the previous 30 days.
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Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Parkway Medical Center | Birmingham | Alabama | United States | 35215 |
2 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35233 |
3 | Wright Clinical Research, LLC | Birmingham | Alabama | United States | 35243 |
4 | Cullman Clinical Trials | Cullman | Alabama | United States | 35055 |
5 | Digestive Health Specialists of the Southeast | Dothan | Alabama | United States | 36305 |
6 | G & L Research | Foley | Alabama | United States | 36535 |
7 | Medical Affiliated Research Center | Huntsville | Alabama | United States | 35801 |
8 | East View Medical Research, LLC | Mobile | Alabama | United States | 36608 |
9 | GI Associates of West Alabama, P.C | Tuscaloosa | Alabama | United States | 35406 |
10 | Mayo Clinic - AZ | Phoenix | Arizona | United States | 85054 |
11 | Del Sol Research Management, LLC | Tucson | Arizona | United States | 85712 |
12 | Southern Arizona VA Health Care System (SAVAHCS) | Tucson | Arizona | United States | 85723 |
13 | Lynn Institute of the Ozarks | Little Rock | Arkansas | United States | 72204 |
14 | Applied Research Center of Arkansas | Little Rock | Arkansas | United States | 72212 |
15 | Arkansas Gastroenterology, P.A. | North Little Rock | Arkansas | United States | 72117 |
16 | Fomat Medical Research | Camarillo | California | United States | 93012 |
17 | Alliance Research Institute | Canoga Park | California | United States | 91304 |
18 | GW Research Inc | Chula Vista | California | United States | 91910 |
19 | Paragon Rx Clinical, Inc. | Garden Grove | California | United States | 92840 |
20 | United Medical Doctors | Irvine | California | United States | 92618 |
21 | Prime Care Clinical Research Center | Laguna Hills | California | United States | 92656 |
22 | Gastro Care Institute | Lancaster | California | United States | 93534 |
23 | Facey Medical Foundation | Mission Hills | California | United States | 91345 |
24 | Knowledge Research Center | Orange | California | United States | 92868 |
25 | Desert Oasis Healthcare Medical Group | Palm Springs | California | United States | 92262 |
26 | Palo Alto Veterans Institute for Research | Palo Alto | California | United States | 34304 |
27 | SDG Clinical Research | San Diego | California | United States | 92103 |
28 | San Jose Gastroenterology | San Jose | California | United States | 95116 |
29 | Paragon Rx Clinical, Inc. - Santa Ana | Santa Ana | California | United States | 92840 |
30 | Sansum Clinic | Santa Barbara | California | United States | 93105 |
31 | Unison Clinical Trials | Sherman Oaks | California | United States | 91403 |
32 | Millennium Clinical Trials | Thousand Oaks | California | United States | 91360 |
33 | Dream Team Clinical Research | Upland | California | United States | 91786 |
34 | New West Physicians | Golden | Colorado | United States | 80401 |
35 | Gastroenterology Associates of Fairfield County | Bridgeport | Connecticut | United States | 06606 |
36 | Bridgeport Hospital | Bridgeport | Connecticut | United States | 06610 |
37 | Connecticut Clinical Research Institute | Bristol | Connecticut | United States | 06010 |
38 | Yale University | New Haven | Connecticut | United States | 06519 |
39 | Cornerstone Research Institute | Altamonte Springs | Florida | United States | 32701 |
40 | Vanguard Clinical Research | Fort Myers | Florida | United States | 33907 |
41 | SIMED Health Research | Gainesville | Florida | United States | 32607 |
42 | Westside Center of Clinical Research | Jacksonville | Florida | United States | 32205 |
43 | Shands Jacksonville Medical Center, Inc - University of Florida Health | Jacksonville | Florida | United States | 32206 |
44 | Health Awareness, Inc. | Jupiter | Florida | United States | 33458 |
45 | Pioneer Clinical Research | Lighthouse Point | Florida | United States | 33064 |
46 | Suncoast Research Group, LLC | Miami | Florida | United States | 33135 |
47 | Next Phase Research Alliance | Miami | Florida | United States | 33144 |
48 | Research Associates of South Florida, LLC | Miami | Florida | United States | 33156 |
49 | Gastro Health Research | Miami | Florida | United States | 33176 |
50 | Gastroenterology Group of Naples | Naples | Florida | United States | 34102 |
51 | Sarkis Clinical Trials | Ocala | Florida | United States | 34471 |
52 | Imic, Inc. | Palmetto Bay | Florida | United States | 33157 |
53 | Family Medical Specialists of Florida, PLC | Plant City | Florida | United States | 33563 |
54 | Alternative Solutions, LLC | Saint Petersburg | Florida | United States | 33711 |
55 | Precision Clinical Research, LLC | Sunrise | Florida | United States | 33351 |
56 | Clinical Trials of Tampa | Tampa | Florida | United States | 33614 |
57 | Summit Clinical Research, LLC | Athens | Georgia | United States | 30607 |
58 | Augusta University | Augusta | Georgia | United States | 30912 |
59 | Atlanta Center for Gastroenterology, P.C. | Decatur | Georgia | United States | 30033 |
60 | Infinite Clinical Trials | Riverdale | Georgia | United States | 30274 |
61 | Grand Teton Research Group | Idaho Falls | Idaho | United States | 83404 |
62 | Christie Clinic | Champaign | Illinois | United States | 61882 |
63 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
64 | GI Partners of IL / Avicenna | Downers Grove | Illinois | United States | 60515 |
65 | Edward Hines Jr. VA Hospital | Hines | Illinois | United States | 60141 |
66 | Southwest Gastroenterology | Oak Lawn | Illinois | United States | 60453 |
67 | Margaret Mary Health | Batesville | Indiana | United States | 47006 |
68 | Deaconess Clinic, Inc. | Evansville | Indiana | United States | 47713 |
69 | Richard L. Roudebush VA Medical Center | Indianapolis | Indiana | United States | 46202 |
70 | Deaconess Clinic, Inc. | Newburgh | Indiana | United States | 47630 |
71 | The South Bend Clinic | South Bend | Indiana | United States | 46617 |
72 | PMG Research | Ames | Iowa | United States | 50010 |
73 | University of Iowa | Iowa City | Iowa | United States | 52242 |
74 | The Iowa Clinic, P.C. | West Des Moines | Iowa | United States | 50266 |
75 | Digestive Health Center of the Four States, LLC | Galena | Kansas | United States | 66739 |
76 | Hutchinson Clinic | Hutchinson | Kansas | United States | 67502 |
77 | Ascension Via Christi Hospitals Wichita, Inc | Wichita | Kansas | United States | 67214 |
78 | St. Elizabeth Healthcare | Edgewood | Kentucky | United States | 41017 |
79 | Horizon Research Group of Opelousas, LLC | Eunice | Louisiana | United States | 70535 |
80 | Houma Digestive Health Specialists-CroNOLA | Houma | Louisiana | United States | 70360 |
81 | Combined Gastro Research, LLC | Lafayette | Louisiana | United States | 70503 |
82 | Clinical Trials of SWLA, LLC | Lake Charles | Louisiana | United States | 70601 |
83 | Clinical Trials Management, LLC | Metairie | Louisiana | United States | 70006 |
84 | New Orleans Research Institute | Metairie | Louisiana | United States | 70006 |
85 | Delta Research Partners | Monroe | Louisiana | United States | 71201 |
86 | Louisiana Research Center; Gastrointestinal Associates | Shreveport | Louisiana | United States | 71105 |
87 | Clinical Trials of America, LLC | West Monroe | Louisiana | United States | 71291 |
88 | Investigative Clinical Research, LLC | Annapolis | Maryland | United States | 21401 |
89 | Chevy Chase Clinical Research | Chevy Chase | Maryland | United States | 20815 |
90 | Centennial Medical Group | Elkridge | Maryland | United States | 21075 |
91 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
92 | Beth Israel Deaconess Medical Center - Harvard | Boston | Massachusetts | United States | 02215 |
93 | IQVIA RDS, Inc. | Cambridge | Massachusetts | United States | 02139 |
94 | Digestive Health Specialists, PC | Chelmsford | Massachusetts | United States | 01824 |
95 | NECCR PrimaCare Research, LLC | Fall River | Massachusetts | United States | 02721 |
96 | University of Massachusetts - Worcester | Worcester | Massachusetts | United States | 01655 |
97 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
98 | Clinical Research Institute of Michigan, LLC | Troy | Michigan | United States | 48098 |
99 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
100 | Southern Therapy and Advanced Research LLC (STAR) | Jackson | Mississippi | United States | 39216 |
101 | Clinical Research Professionals | Chesterfield | Missouri | United States | 63005 |
102 | Sundance Clinical Research, LLC | Saint Louis | Missouri | United States | 63141 |
103 | Methodist Physicians Clinic / CCT Research | Fremont | Nebraska | United States | 68025 |
104 | CHI Nebraska | Omaha | Nebraska | United States | 68124 |
105 | University of Nevada, Las Vegas | Las Vegas | Nevada | United States | 89102 |
106 | Clinical Research of South Nevada | Las Vegas | Nevada | United States | 89121 |
107 | Digestive Health Associates | Reno | Nevada | United States | 89511 |
108 | AGA Clinical Research Associates, LLC | Egg Harbor Township | New Jersey | United States | 08234 |
109 | Allied Health Clinical Research Organization, LLC | West Long Branch | New Jersey | United States | 07764 |
110 | United Health Services Hospitals, Inc. | Binghamton | New York | United States | 13903 |
111 | VA NY Harbor HCS- Brooklyn Campus | Brooklyn | New York | United States | 11209 |
112 | Sing Chan, MD | Flushing | New York | United States | 11354 |
113 | Mid Hudson Medical Research, PLLC | New Windsor | New York | United States | 12553 |
114 | Icahn School of Medicine at Mount Sinai | New York | New York | United States | 10029 |
115 | DiGiovanna Institute for Medical Education & Research | North Massapequa | New York | United States | 11758 |
116 | Digestive Health Partners, PA | Asheville | North Carolina | United States | 28801 |
117 | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States | 27599 |
118 | Atrium Health Department of Family Medicine Research | Charlotte | North Carolina | United States | 28207 |
119 | Javara | Charlotte | North Carolina | United States | 28210 |
120 | Cumberland Research Associates LLC | Fayetteville | North Carolina | United States | 28304 |
121 | Medication Management LLC | Greensboro | North Carolina | United States | 27405 |
122 | Peters Medical Research | High Point | North Carolina | United States | 27262 |
123 | Clinical Trials of America, LLC | Mount Airy | North Carolina | United States | 27030 |
124 | Coastal Carolina Health Care, P.A. | New Bern | North Carolina | United States | 28562 |
125 | Wr-Msra, Llc | Raleigh | North Carolina | United States | 27612 |
126 | Trial Management Associates, LLC | Wilmington | North Carolina | United States | 28403 |
127 | Lillestol Research, LLC | Fargo | North Dakota | United States | 58104 |
128 | Plains Clinical Research Center, LLC | Fargo | North Dakota | United States | 58104 |
129 | Great Lakes Medical Research, LLC | Beachwood | Ohio | United States | 44122 |
130 | Consultants for Clinical Research | Cincinnati | Ohio | United States | 45219 |
131 | Hightop Medical Research Clinic | Cincinnati | Ohio | United States | 45224 |
132 | University Hospitals Cleveland Medical Center | Cleveland | Ohio | United States | 44106 |
133 | Dayton Clinical Resesarch | Dayton | Ohio | United States | 45409 |
134 | META Medical Research Institute, LLC | Dayton | Ohio | United States | 45432 |
135 | Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | United States | 44060 |
136 | Paramount Medical Research and Consulting, LLC | Middleburg Heights | Ohio | United States | 44130 |
137 | Northshore Gastroenterology Research, LLC | Westlake | Ohio | United States | 44145 |
138 | Comprehensive Internal Medicine, Inc | Wooster | Ohio | United States | 44691 |
139 | Intend Research LLC | Norman | Oklahoma | United States | 73069 |
140 | SSM Health Medical Group/Hightower Clinical | Oklahoma City | Oklahoma | United States | 73102 |
141 | Options Health Research, LLC | Tulsa | Oklahoma | United States | 74104 |
142 | Great Lakes Medical Research, LLC | Harrisburg | Pennsylvania | United States | 17110 |
143 | Richard M. Kastelic, M.D., and Associates, P.C. | Johnstown | Pennsylvania | United States | 15905 |
144 | Regional GI | Lancaster | Pennsylvania | United States | 17601 |
145 | Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
146 | Care Access Research, Pottsville | Pottsville | Pennsylvania | United States | 17901 |
147 | Ralph H. Johnson VAMC | Charleston | South Carolina | United States | 29401 |
148 | Pharmacorp Clinical Trials, Inc. | Charleston | South Carolina | United States | 29412 |
149 | Invocare Medical Research & Healthcare Center | West Columbia | South Carolina | United States | 29169 |
150 | WR-ClinSearch, LLC | Chattanooga | Tennessee | United States | 37421 |
151 | Gastro One | Germantown | Tennessee | United States | 38138 |
152 | Clinical Research Solutions, LLC - TN | Jackson | Tennessee | United States | 38305 |
153 | The Jackson Clinic, PA | Jackson | Tennessee | United States | 38305 |
154 | The Jackson Clinic, PA | Jackson | Tennessee | United States | 38305 |
155 | Tri-Cities | Kingsport | Tennessee | United States | 37663 |
156 | Great Lakes Medical Research, LLC | Union City | Tennessee | United States | 38261 |
157 | ARC Clinical Research at Wilson Parke | Austin | Texas | United States | 78726 |
158 | Elligo Health Research Inc. | Austin | Texas | United States | 78738 |
159 | ARC Clinical Research at William Cannon | Austin | Texas | United States | 78745 |
160 | Avant Research Associates | Austin | Texas | United States | 78748 |
161 | Mercy Family Clinic | Dallas | Texas | United States | 75211 |
162 | Dharma PA D/B/A Southwest Family Medicine Associates | Dallas | Texas | United States | 75235 |
163 | Texas Tech University Health Sciences Center El Paso | El Paso | Texas | United States | 79905 |
164 | Houston Digestive Disease | Houston | Texas | United States | 77030 |
165 | UT MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
166 | Biopharma Informatic, LLC | Houston | Texas | United States | 77084 |
167 | Fairway Medical Clinic | Houston | Texas | United States | 77087 |
168 | Digestive System Healthcare | Houston | Texas | United States | 77505 |
169 | FMC Science, LLC | Lampasas | Texas | United States | 76550 |
170 | Rio Grande Gastroenterology | McAllen | Texas | United States | 78503 |
171 | Wellness Clinical Research | McKinney | Texas | United States | 75071 |
172 | ARC Clinical Research at Kelly Lane | Pflugerville | Texas | United States | 78660 |
173 | Epic Medical Research, LLC | Red Oak | Texas | United States | 75154 |
174 | Clinical Associates in Research Therapeutics of America | San Antonio | Texas | United States | 78212 |
175 | Gastroenterology Research of San Antonio | San Antonio | Texas | United States | 78229 |
176 | Texas Gastro Consultants | Tomball | Texas | United States | 77375 |
177 | Progressive Clinical Research, LLC | Bountiful | Utah | United States | 84010 |
178 | Tanner Clinic | Layton | Utah | United States | 84041 |
179 | Advanced Research Institute | Ogden | Utah | United States | 84401 |
180 | Advanced Clinical Research | Riverton | Utah | United States | 84065 |
181 | Granger Medical Clinic | Riverton | Utah | United States | 84096 |
182 | Advanced Research Institute | Sandy | Utah | United States | 84092 |
183 | Blue Ridge Medical Research | Lynchburg | Virginia | United States | 24502 |
184 | Summit Clinical Research | Petersburg | Virginia | United States | 23805 |
185 | Central Virginia VA Healthcare System | Richmond | Virginia | United States | 23249 |
186 | Virginia Gastroenterology Institute | Suffolk | Virginia | United States | 23434 |
187 | Benaroya Research Institute at Virginia Mason | Seattle | Washington | United States | 98101 |
188 | Spokane Gastroenterology | Spokane | Washington | United States | 99204 |
189 | Wenatchee Valley Hospital | Wenatchee | Washington | United States | 98801 |
190 | University Physicians and Surgeons, Inc. DBA Marshall Health | Huntington | West Virginia | United States | 25701 |
191 | University of Wisconsin Hospital and Clinics | Madison | Wisconsin | United States | 53215 |
192 | Ascension Wisconsin | Milwaukee | Wisconsin | United States | 53211 |
193 | Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | United States | 53215 |
Sponsors and Collaborators
- Exact Sciences Corporation
Investigators
- Principal Investigator: Thomas Imperiale, MD, Indiana University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-01