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
Enrollment
183
Locations
35.5
Anticipated Duration (Months)
131.1
Patients Per Site
3.7
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

SiteCityStateCountryPostal Code
1Parkway Medical CenterBirminghamAlabamaUnited States35215
2University of Alabama at BirminghamBirminghamAlabamaUnited States35233
3Wright Clinical Research, LLCBirminghamAlabamaUnited States35243
4Cullman Clinical TrialsCullmanAlabamaUnited States35055
5Digestive Health Specialists of the SoutheastDothanAlabamaUnited States36305
6G & L ResearchFoleyAlabamaUnited States36535
7Medical Affiliated Research CenterHuntsvilleAlabamaUnited States35801
8East View Medical Research, LLCMobileAlabamaUnited States36608
9GI Associates of West Alabama, P.CTuscaloosaAlabamaUnited States35406
10Mayo Clinic - AZPhoenixArizonaUnited States85054
11Del Sol Research Management, LLCTucsonArizonaUnited States85712
12Lynn Institute of the OzarksLittle RockArkansasUnited States72204
13Applied Research Center of ArkansasLittle RockArkansasUnited States72212
14Arkansas Gastroenterology, P.A.North Little RockArkansasUnited States72117
15Fomat Medical ResearchCamarilloCaliforniaUnited States93012
16Alliance Research InstituteCanoga ParkCaliforniaUnited States91304
17GW Research IncChula VistaCaliforniaUnited States91910
18Paragon Rx Clinical, Inc.Garden GroveCaliforniaUnited States92840
19United Medical DoctorsIrvineCaliforniaUnited States92618
20Prime Care Clinical Research CenterLaguna HillsCaliforniaUnited States92656
21Gastro Care InstituteLancasterCaliforniaUnited States93534
22Facey Medical FoundationMission HillsCaliforniaUnited States91345
23Knowledge Research CenterOrangeCaliforniaUnited States92868
24Desert Oasis Healthcare Medical GroupPalm SpringsCaliforniaUnited States92262
25SDG Clinical ResearchSan DiegoCaliforniaUnited States92103
26San Jose GastroenterologySan JoseCaliforniaUnited States95116
27Paragon Rx Clinical, Inc. - Santa AnaSanta AnaCaliforniaUnited States92840
28Sansum ClinicSanta BarbaraCaliforniaUnited States93105
29Unison Clinical TrialsSherman OaksCaliforniaUnited States91403
30Dream Team Clinical ResearchUplandCaliforniaUnited States91786
31New West PhysiciansGoldenColoradoUnited States80401
32Gastroenterology Associates of Fairfield CountyBridgeportConnecticutUnited States06606
33Bridgeport HospitalBridgeportConnecticutUnited States06610
34Connecticut Clinical Research InstituteBristolConnecticutUnited States06010
35Yale UniversityNew HavenConnecticutUnited States06519
36Cornerstone Research InstituteAltamonte SpringsFloridaUnited States32701
37Vanguard Clinical ResearchFort MyersFloridaUnited States33907
38SIMED Health ResearchGainesvilleFloridaUnited States32607
39Westside Center of Clinical ResearchJacksonvilleFloridaUnited States32205
40Shands Jacksonville Medical Center, Inc - University of Florida HealthJacksonvilleFloridaUnited States32206
41Health Awareness, Inc.JupiterFloridaUnited States33458
42Multi-Specialty Research AssociatesLake CityFloridaUnited States32055
43Pioneer Clinical ResearchLighthouse PointFloridaUnited States33064
44Suncoast Research Group, LLCMiamiFloridaUnited States33135
45Next Phase Research AllianceMiamiFloridaUnited States33144
46Research Associates of South Florida, LLCMiamiFloridaUnited States33156
47Gastro HealthMiamiFloridaUnited States33173
48Gastroenterology Group of NaplesNaplesFloridaUnited States34102
49Sarkis Clinical TrialsOcalaFloridaUnited States34471
50Imic, Inc.Palmetto BayFloridaUnited States33157
51Family Medical Specialists of Florida, PLCPlant CityFloridaUnited States33563
52Alternative Solutions, LLCSaint PetersburgFloridaUnited States33711
53Precision Clinical Research, LLCSunriseFloridaUnited States33351
54Clinical Trials of TampaTampaFloridaUnited States33614
55Summit Clinical Research, LLCAthensGeorgiaUnited States30607
56Augusta UniversityAugustaGeorgiaUnited States30912
57Atlanta Center for Gastroenterology, P.C.DecaturGeorgiaUnited States30033
58Infinite Clinical TrialsRiverdaleGeorgiaUnited States30274
59Grand Teton Research GroupIdaho FallsIdahoUnited States83404
60Christie ClinicChampaignIllinoisUnited States61882
61Rush University Medical CenterChicagoIllinoisUnited States60612
62GI Partners of IL / AvicennaDowners GroveIllinoisUnited States60515
63Southwest GastroenterologyOak LawnIllinoisUnited States60453
64Margaret Mary HealthBatesvilleIndianaUnited States47006
65Deaconess Clinic, Inc.EvansvilleIndianaUnited States47713
66Deaconess Clinic, Inc.NewburghIndianaUnited States47630
67The South Bend ClinicSouth BendIndianaUnited States46617
68PMG ResearchAmesIowaUnited States50010
69University of IowaIowa CityIowaUnited States52242
70The Iowa Clinic, P.C.West Des MoinesIowaUnited States50266
71Digestive Health Center of the Four States, LLCGalenaKansasUnited States66739
72Hutchinson ClinicHutchinsonKansasUnited States67502
73Ascension Via Christi Hospitals Wichita, IncWichitaKansasUnited States67214
74Horizon Research Group of Opelousas, LLCEuniceLouisianaUnited States70535
75Houma Digestive Health Specialists-CroNOLAHoumaLouisianaUnited States70360
76Combined Gastro Research, LLCLafayetteLouisianaUnited States70503
77Clinical Trials of SWLA, LLCLake CharlesLouisianaUnited States70601
78Clinical Trials Management, LLCMetairieLouisianaUnited States70006
79New Orleans Research InstituteMetairieLouisianaUnited States70006
80Delta Research PartnersMonroeLouisianaUnited States71201
81Louisiana Research Center; Gastrointestinal AssociatesShreveportLouisianaUnited States71105
82Clinical Trials of America, LLCWest MonroeLouisianaUnited States71291
83Investigative Clinical Research, LLCAnnapolisMarylandUnited States21401
84Chevy Chase Clinical ResearchChevy ChaseMarylandUnited States20815
85Centennial Medical GroupElkridgeMarylandUnited States21075
86Massachusetts General HospitalBostonMassachusettsUnited States02114
87Beth Israel Deaconess Medical Center - HarvardBostonMassachusettsUnited States02215
88IQVIA RDS, Inc.CambridgeMassachusettsUnited States02139
89Digestive Health Specialists, PCChelmsfordMassachusettsUnited States01824
90NECCR PrimaCare Research, LLCFall RiverMassachusettsUnited States02721
91University of Massachusetts - WorcesterWorcesterMassachusettsUnited States01655
92University of MichiganAnn ArborMichiganUnited States48109
93Center for Digestive Health ResearchTroyMichiganUnited States48098
94Mayo ClinicRochesterMinnesotaUnited States55905
95Southern Therapy and Advanced Research LLC (STAR)JacksonMississippiUnited States39216
96Clinical Research ProfessionalsChesterfieldMissouriUnited States63005
97Sundance Clinical Research, LLCSaint LouisMissouriUnited States63141
98Methodist Physicians Clinic / CCT ResearchFremontNebraskaUnited States68025
99CHI NebraskaOmahaNebraskaUnited States68124
100University of Nevada, Las VegasLas VegasNevadaUnited States89102
101Clinical Research of South NevadaLas VegasNevadaUnited States89121
102Digestive Health AssociatesRenoNevadaUnited States89511
103AGA Clinical Research Associates, LLCEgg Harbor TownshipNew JerseyUnited States08234
104Allied Health Clinical Research Organization, LLCWest Long BranchNew JerseyUnited States07764
105United Health Services Hospitals, Inc.BinghamtonNew YorkUnited States13903
106VA NY Harbor HCS- Brooklyn CampusBrooklynNew YorkUnited States11209
107Sing Chan, MDFlushingNew YorkUnited States11354
108Mid Hudson Medical Research, PLLCNew WindsorNew YorkUnited States12553
109Icahn School of Medicine at Mount SinaiNew YorkNew YorkUnited States10029
110DiGiovanna Institute for Medical Education & ResearchNorth MassapequaNew YorkUnited States11758
111Digestive Health Partners, PAAshevilleNorth CarolinaUnited States28801
112University of North Carolina at Chapel HillChapel HillNorth CarolinaUnited States27599
113Atrium Health Department of Family Medicine ResearchCharlotteNorth CarolinaUnited States28207
114JavaraCharlotteNorth CarolinaUnited States28210
115Cumberland Research Associates LLCFayettevilleNorth CarolinaUnited States28304
116Medication Management LLCGreensboroNorth CarolinaUnited States27408
117Peters Medical ResearchHigh PointNorth CarolinaUnited States27262
118Clinical Trials of America, LLCMount AiryNorth CarolinaUnited States27030
119Coastal Carolina Health Care, P.A.New BernNorth CarolinaUnited States28562
120Trial Management Associates, LLCWilmingtonNorth CarolinaUnited States28403
121Lillestol Research, LLCFargoNorth DakotaUnited States58104
122Plains Clinical Research Center, LLCFargoNorth DakotaUnited States58104
123Great Lakes Medical Research, LLCBeachwoodOhioUnited States44122
124Consultants for Clinical ResearchCincinnatiOhioUnited States45219
125Hightop Medical Research ClinicCincinnatiOhioUnited States45224
126University Hospitals Cleveland Medical CenterClevelandOhioUnited States44106
127Dayton Clinical ResesarchDaytonOhioUnited States45409
128META Medical Research Institute, LLCDaytonOhioUnited States45432
129Great Lakes Gastroenterology Research, LLCMentorOhioUnited States44060
130Paramount Medical Research and Consulting, LLCMiddleburg HeightsOhioUnited States44130
131Northshore Gastroenterology Research, LLCWestlakeOhioUnited States44145
132Comprehensive Internal Medicine, IncWoosterOhioUnited States44691
133Intend Research LLCNormanOklahomaUnited States73069
134SSM Health Medical Group/Hightower ClinicalOklahoma CityOklahomaUnited States73102
135Options Health Research, LLCTulsaOklahomaUnited States74104
136Great Lakes Medical Research, LLCHarrisburgPennsylvaniaUnited States17110
137Richard M. Kastelic, M.D., and Associates, P.C.JohnstownPennsylvaniaUnited States15905
138Regional GILancasterPennsylvaniaUnited States17601
139Thomas Jefferson UniversityPhiladelphiaPennsylvaniaUnited States19107
140Care Access Research, PottsvillePottsvillePennsylvaniaUnited States17901
141Pharmacorp Clinical Trials, Inc.CharlestonSouth CarolinaUnited States29412
142Invocare Medical Research & Healthcare CenterWest ColumbiaSouth CarolinaUnited States29169
143WR-ClinSearch, LLCChattanoogaTennesseeUnited States37421
144Gastro OneGermantownTennesseeUnited States38138
145Clinical Research Solutions, LLC - TNJacksonTennesseeUnited States38305
146The Jackson Clinic, PAJacksonTennesseeUnited States38305
147The Jackson Clinic, PAJacksonTennesseeUnited States38305
148Tri-CitiesKingsportTennesseeUnited States37663
149Great Lakes Medical Research, LLCUnion CityTennesseeUnited States38261
150ARC Clinical Research at Wilson ParkeAustinTexasUnited States78726
151Elligo Health Research Inc.AustinTexasUnited States78738
152ARC Clinical Research at William CannonAustinTexasUnited States78745
153Avant Research AssociatesAustinTexasUnited States78748
154Mercy Family ClinicDallasTexasUnited States75211
155Dharma PA D/B/A Southwest Family Medicine AssociatesDallasTexasUnited States75235
156Texas Tech University Health Sciences Center El PasoEl PasoTexasUnited States79905
157Houston Digestive DiseaseHoustonTexasUnited States77030
158UT MD Anderson Cancer CenterHoustonTexasUnited States77030
159Biopharma Informatic, LLCHoustonTexasUnited States77084
160Fairway Medical ClinicHoustonTexasUnited States77087
161Digestive System HealthcareHoustonTexasUnited States77505
162FMC Science, LLCLampasasTexasUnited States76550
163Rio Grande GastroenterologyMcAllenTexasUnited States78503
164Wellness Clinical ResearchMcKinneyTexasUnited States75071
165ARC Clinical Research at Kelly LanePflugervilleTexasUnited States78660
166Epic Medical Research, LLCRed OakTexasUnited States75154
167Clinical Associates in Research Therapeutics of AmericaSan AntonioTexasUnited States78212
168Gastroenterology Research of San AntonioSan AntonioTexasUnited States78229
169Texas Gastro ConsultantsTomballTexasUnited States77375
170Progressive Clinical Research, LLCBountifulUtahUnited States84010
171Tanner ClinicLaytonUtahUnited States84041
172Advanced Research InstituteOgdenUtahUnited States84401
173Advanced Clinical ResearchRivertonUtahUnited States84065
174Granger Medical ClinicRivertonUtahUnited States84096
175Advanced Research InstituteSandyUtahUnited States84092
176Blue Ridge Medical ResearchLynchburgVirginiaUnited States24502
177Summit Clinical ResearchPetersburgVirginiaUnited States23805
178Virginia Gastroenterology InstituteSuffolkVirginiaUnited States23434
179Benaroya Research Institute at Virginia MasonSeattleWashingtonUnited States98101
180Spokane GastroenterologySpokaneWashingtonUnited States99204
181Wenatchee Valley HospitalWenatcheeWashingtonUnited States98801
182Ascension WisconsinMilwaukeeWisconsinUnited States53211
183Wisconsin Center for Advanced ResearchMilwaukeeWisconsinUnited States53215

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:
Apr 8, 2022
Last Verified:
Jan 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 Apr 8, 2022