Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors

Sponsor
Exact Sciences Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03662204
Collaborator
(none)
5,000
Enrollment
119
Locations
43.2
Anticipated Duration (Months)
42
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.

Detailed Description

Subjects who have been diagnosed, or who have a suspicion of diagnosis based on imaging, with any solid tumor. Subjects will have a blood sample collected at enrollment and provide medical history prior to initiation of treatment. There will be no further follow-up.

Study Design

Study Type:
Observational
Anticipated Enrollment :
5000 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
Actual Study Start Date :
Aug 23, 2018
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Mar 31, 2022

Arms and Interventions

ArmIntervention/Treatment
Breast

Subjects with clinically confirmed breast cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.

Lung

Subjects with clinically confirmed lung cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.

Colorectal

Subjects with clinically confirmed colorectal cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.

Prostate

Subjects with clinically confirmed prostate cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.

Bladder

Subjects with clinically confirmed or suspicion of bladder cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.

Uterine

Subjects with clinically confirmed uterine cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.

Kidney & Renal Pelvis

Subjects with clinically confirmed or suspicion of kidney or renal pelvis cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.

Pancreatic

Subjects with clinically confirmed or suspicion of pancreatic cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.

Liver

Subjects with clinically confirmed liver cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.

Stomach

Subjects with clinically confirmed stomach cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.

Ovarian

Subjects with clinically confirmed or suspicion of ovarian cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.

Esophageal

Subjects with clinically confirmed esophageal cancer and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.

Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.

Outcome Measures

Primary Outcome Measures

  1. Biomarker Evaluation [Point in time (one day) blood collection at enrollment]

    Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with solid tumor cancers.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Subject is male or female > 18 years of age.

  2. Subject has an untreated primary malignancy of breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian or esophageal cancer.

OR

Subject has suspicion of a primary malignancy of pancreatic, bladder, kidney/renal pelvis, or ovarian cancer based on imaging.

  1. Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Exclusion Criteria:
  1. Prior or concurrent cancer diagnosis defined as:

  2. Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); OR

  3. Recurrence of the same primary cancer within any timeframe; OR

  4. Concurrent diagnosis of multiple primary cancers

  5. Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.

  6. Any treatment for the primary malignancy or sites of metastases. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment and/or surgery prior to blood sample collection.

  7. Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.

  8. Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.

  9. IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.

  10. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Mayo Clinic HospitalPhoenixArizonaUnited States85054
2Scottsdale Medical Imaging ResearchScottsdaleArizonaUnited States85258
3Arizona Clinical Research Center, Inc.TucsonArizonaUnited States85715
4Urological Associates of Southern Arizona, PCTucsonArizonaUnited States85741
5Mercy Research-Fort SmithFort SmithArkansasUnited States72903
6Genesis Cancer CenterHot SpringsArkansasUnited States71913
7NEA Fowler Family Center for Cancer CareJonesboroArkansasUnited States72401
8CARTI Cancer CenterLittle RockArkansasUnited States72205
9John Muir Clinical ResearchConcordCaliforniaUnited States94520
10Marin Cancer CareGreenbraeCaliforniaUnited States94904
11Alliance Research CentersLaguna HillsCaliforniaUnited States92653
12Office of John Homan, MDNewport BeachCaliforniaUnited States92663
13North County OncologyOceansideCaliforniaUnited States92056
14UCI Department of UrologyOrangeCaliforniaUnited States92868
15Adventist Health - Saint Helena HospitalSaint HelenaCaliforniaUnited States94574
16Sharp Memorial HospitalSan DiegoCaliforniaUnited States92123
17St. Joseph Heritage HealthcareSanta RosaCaliforniaUnited States95403
18Innovative Clinical Research InstituteWhittierCaliforniaUnited States90603
19RMR VA Medical CenterAuroraColoradoUnited States80045
20The Urology Center of ColoradoDenverColoradoUnited States80211
21Middlesex HospitalMiddletownConnecticutUnited States06457
22Easter Ct Hematology and OncologyNorwichConnecticutUnited States06360
23Stamford HospitalStamfordConnecticutUnited States06904
24Southeast Florida Hematology-Oncology Group, PAFort LauderdaleFloridaUnited States33308
25CSNF - Central Business OfficeJacksonvilleFloridaUnited States32256
26Jupiter Medical CenterJupiterFloridaUnited States33458
27Mount Sinai Medical CenterMiami BeachFloridaUnited States33140
28Mid Florida Hematology and Oncology CenterOrange CityFloridaUnited States32763
29Sarasota Memorial HospitalSarasotaFloridaUnited States34203
30University Cancer & Blood Center, LLCAthensGeorgiaUnited States30607
31Piedmont Cancer Institute, PCAtlantaGeorgiaUnited States30318
32Candler HospitalSavannahGeorgiaUnited States31405
33Lewis Hall Singletary Oncology CenterThomasvilleGeorgiaUnited States31792
34John H. Stroger, Jr. Hospital of Cook CountyChicagoIllinoisUnited States60612
35PMG Research of DuPage Medical GroupDowners GroveIllinoisUnited States60515
36Presence Cancer Care / JOHAJolietIllinoisUnited States60435
37Illinois CancerCare, P.C.PeoriaIllinoisUnited States61615
38Orchard Healthcare Reasearch IncSkokieIllinoisUnited States60077
39SIU School of MedicineSpringfieldIllinoisUnited States62702
40Investigative Clinical Research of Indiana, LLCIndianapolisIndianaUnited States46260
41PMG Research of McFarland ClinicAmesIowaUnited States50010
42Des Moines Oncology Research AssociateDes MoinesIowaUnited States50309
43Oncology Fort Thomas St. Elizabeth's Edgewood Cancer Care ResearchEdgewoodKentuckyUnited States41017
44Baptist Health-LexingtonLexingtonKentuckyUnited States40503
45Norton Cancer Institute-PavilionLouisvilleKentuckyUnited States40202
46Baptist HealthLouisvilleKentuckyUnited States40207
47Baptist Health- PaducahPaducahKentuckyUnited States42001
48Greater Baltimore Medical CenterBaltimoreMarylandUnited States68506
49Holy Cross Hospital Resource Center Department of Cancer ResearchSilver SpringMarylandUnited States20902
50Beverly Hospital, OncologyBeverlyMassachusettsUnited States01915
51Massachusetts General HospitalBostonMassachusettsUnited States02114
52Lowell General HospitalLowellMassachusettsUnited States01854
53Cancer and Hematology Centers of Western Michigan, PCGrand RapidsMichiganUnited States49503
54Cancer Research Consortium of West Michigan (CRCWM)Grand RapidsMichiganUnited States49503
55Ascension Providence HospitalsSouthfieldMichiganUnited States48075
56Metro-Minnesota Community Oncology Research Consortium (MMCORC)Saint Louis ParkMinnesotaUnited States55416
57Park Nicollet Institute - Oncology ResearchSaint Louis ParkMinnesotaUnited States55426
58St. Dominic's Gynecologic OncologyJacksonMississippiUnited States39216
59North Mississippi Medical Center Hematology and OncologyTupeloMississippiUnited States38801
60Mercy Cancer CenterJoplinMissouriUnited States64804
61Missouri Baptist Medical CenterSaint LouisMissouriUnited States63131
62Mercy HospitalSaint LouisMissouriUnited States63141
63Mercy Cancer and Hematology ClinicSpringfieldMissouriUnited States65804
64Nebraska Hematology-Oncology -- LincolnLincolnNebraskaUnited States68506
65Somnos Laboratories, Inc.LincolnNebraskaUnited States68510
66Cancer Care SpecialistsRenoNevadaUnited States89519
67The Minniti Center for Hematology and OncologyMickletonNew JerseyUnited States08056
68Riverview Medical CenterRed BankNew JerseyUnited States07701
69Albany Medical CollegeAlbanyNew YorkUnited States12208
70Brooklyn Urology Research GroupBrooklynNew YorkUnited States11201
71Roswell Park Cancer InstituteBuffaloNew YorkUnited States14263
72Hematology Oncology Associates of Central New YorkEast SyracuseNew YorkUnited States13057
73Premier Medical Group of the Hudson Valley PCPoughkeepsieNew YorkUnited States12601
74Premier Medical Group of the Hudson Valley, PC Research Department - Gastroenterology DivisionPoughkeepsieNew YorkUnited States12601
75Richmond University Medical CenterStaten IslandNew YorkUnited States10310
76Stony Brook Cancer CenterStony BrookNew YorkUnited States11794
77Associated Medical ProfessionalsSyracuseNew YorkUnited States13210
78Cone Health Cancer CenterGreensboroNorth CarolinaUnited States27403
79PMG Research of Hickory, LLCHickoryNorth CarolinaUnited States28601
80FirstHealth Moore Regional HospitalPinehurstNorth CarolinaUnited States28374
81PMG Research of Rocky MountRocky MountNorth CarolinaUnited States27804
82PMG Research of PiedmontStatesvilleNorth CarolinaUnited States28625
83Marion L. Shepard Cancer CenterWashingtonNorth CarolinaUnited States27889
84Zimmer Cancer CenterWilmingtonNorth CarolinaUnited States28402
85Hematology & Oncology Associates, Inc.CantonOhioUnited States44708
86Tri-County Hematology & Oncology Associates, Inc.MassillonOhioUnited States44646
87Cancer Centers of Southwest OklahomaLawtonOklahomaUnited States73505
88Genie Jackson Stephenson Cancer CenterOklahoma CityOklahomaUnited States73104
89Mercy Oncology ResearchOklahoma CityOklahomaUnited States73120
90St. Luke's University Health NetworkBethlehemPennsylvaniaUnited States18015
91Women & Infants HospitalProvidenceRhode IslandUnited States02905
92Charleston Cancer CenterCharlestonSouth CarolinaUnited States29406
93McLeod Center for Cancer Treatment and ResearchFlorenceSouth CarolinaUnited States29506
94Saint Francis Cancer Center Research DepartmentGreenvilleSouth CarolinaUnited States29607
95Lowcountry Urology/PMG Research of Charleston, LLCNorth CharlestonSouth CarolinaUnited States29406
96Spartanburg Medical Center: Gibbs Cancer Center & Research InstituteSpartanburgSouth CarolinaUnited States29303
97Lexington Medical CenterWest ColumbiaSouth CarolinaUnited States29169
98RH Clinical ResearchRapid CitySouth DakotaUnited States57701
99PMG Research of Bristol, LLCBristolTennesseeUnited States37620
100The Jackson ClinicJacksonTennesseeUnited States38301
101Christus Spohn Cancer CenterCorpus ChristiTexasUnited States78404
102University of Texas Health Science CenterHoustonTexasUnited States77030
103Sun Research InstituteSan AntonioTexasUnited States78215
104San Antonio Military Medical CenterSan AntonioTexasUnited States78234
105Cancer Treatment CenterTexarkanaTexasUnited States75503
106Renovatio ClinicalThe WoodlandsTexasUnited States77380
107Community Cancer Trials of UtahOgdenUtahUnited States84405
108Utah Cancer SpecialistsSalt Lake CityUtahUnited States84106
109Virginia Cancer InstituteRichmondVirginiaUnited States23230
110Urology of Virginia, PLLCVirginia BeachVirginiaUnited States23462
111Seattle Urology Research CenterBurienWashingtonUnited States98166
112MultiCare Regional Cancer CenterTacomaWashingtonUnited States98405
113CAMC Clinical Trials CenterCharlestonWest VirginiaUnited States25304
114Mon Health Medical CenterMorgantownWest VirginiaUnited States26505
115West Virginia University Cancer InstituteMorgantownWest VirginiaUnited States26506
116HSHS St. Vincent HospitalGreen BayWisconsinUnited States54301
117Michael Berry Building-OncologyJanesvilleWisconsinUnited States53548
118UW Carbone Cancer CenterMadisonWisconsinUnited States53792
119ProHealth Care Research InstituteWaukeshaWisconsinUnited States53188

Sponsors and Collaborators

  • Exact Sciences Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Exact Sciences Corporation
ClinicalTrials.gov Identifier:
NCT03662204
Other Study ID Numbers:
  • 2018-01
First Posted:
Sep 7, 2018
Last Update Posted:
Oct 4, 2021
Last Verified:
Sep 1, 2021
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 Oct 4, 2021