Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"

Sponsor
Exact Sciences Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04144738
Collaborator
(none)
24,000
193
35.5
124.4
3.5

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
  • Diagnostic Test: mt-sDNA 2.0 screening test
  • Diagnostic Test: FIT test
  • Procedure: Colonoscopy

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

Study Type:
Observational
Anticipated Enrollment :
24000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"
Actual Study Start Date :
Nov 15, 2019
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Sensitivity for CRC with the mt-sDNA 2.0 test [Through study completion, an average of 180 days]

  2. Specificity with the mt-sDNA 2.0 test [Through study completion, an average of 180 days]

Secondary Outcome Measures

  1. Sensitivity for advanced precancerous lesions [Through study completion, an average of 180 days]

  2. Sensitivity for CRC compared to a commercially available fecal immunochemical test (FIT) [Through study completion, an average of 180 days]

  3. Sensitivity for advanced precancerous lesions compared to commercially available fecal immunochemical test (FIT). [Through study completion, an average of 180 days]

  4. Specificity for no colorectal neoplastic findings [Through study completion, an average of 180 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
Subjects must meet the following criteria to be eligible for the study:
  1. Subject is ≥ 40 years of age at the time of enrollment.

  2. Subject presents for a screening colonoscopy per standard of care.

  3. Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.

  4. Subject is able and willing to sign informed consent

Exclusion Criteria:
  1. Subject has a history of CRC or advanced precancerous lesions.

  2. Subject has a diagnosis or medical / family history of any of the following conditions, including:

  • Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome),

  • Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome"),

  • 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.

  1. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.

  2. Subject has a diagnosis of Cronkhite-Canada Syndrome.

  3. Subject has had a positive Cologuard within the previous 2 years, or fecal occult blood test or FIT within the previous 6 months.

  4. 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.

  5. Subject has had overt rectal bleeding within the previous 30 days.

  6. 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
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.
Responsible Party:
Exact Sciences Corporation
ClinicalTrials.gov Identifier:
NCT04144738
Other Study ID Numbers:
  • 2019-01
First Posted:
Oct 30, 2019
Last Update Posted:
Aug 12, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Exact Sciences Corporation
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2022