Colo-rectal CancerNCT03741166
Blood Collection Sub-Study for CRC Screening in Individuals 45-49 at Average Risk for CRC.
An observational study of Colo-rectal Cancer, run by Exact Sciences Corporation at 37 sites in United States.
Trial summary
The primary objective of this sub-study, 2018-10B, is to collect blood specimens to assess new biomarkers for the detection of Colorectal Cancer (CRC). Read more about this study
- Who is it for?
- Ages 45 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Blood Sample Collection
- How many people
- 871 participants
- Where
- 37 sitesUnited States
- Study dates
- 8 Nov 2018to 5 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects will be men and women, 45-49 years of age, who enroll in Exact Sciences Protocol 2018-10. Up to 942 subjects will be enrolled.
Who may be able to join
- Subject is currently enrolled in Exact Sciences Protocol 2018-10
- Subject is willing and able to provide a blood sample.
- Subject is willing and able to sign informed consent.
Who cannot join
- 1. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Investigative Clinical Research
Annapolis, Maryland, 21401
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801
Austin Regional Clinic
Austin, Texas, 78726
United Medical Associates
Binghamton, New York, 13901
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, 06606
Commonwealth Clinical Studies
Brockton, Massachusetts, 02302
Ventura County Gastroenterology
Camarillo, California, 93012
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte, North Carolina, 28207
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Centennial Medical Group
Elkridge, Maryland, 21075
Northshore University Health System Evanston Hospital
Evanston, Illinois, 60201
Deaconess Clinic- Mt. Pleasant
Evansville, Indiana, 47725
Gastro One
Germantown, Tennessee, 38138
Gastroenterology Associates, PA
Greenville, South Carolina, 29615
University of Texas Health Science Center- McGovern Medical School
Houston, Texas, 77030
DM Clinical Research- PCP for Life
Houston, Texas, 77070
Alliance Research Centers
Laguna Hills, California, 92653
Precision Clinical Research, LLC
Lauderdale Lakes, Florida, 33319
Johnson County ClinTrials, LLC
Lenexa, Kansas, 66219
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060
New Orleans Research Institue
Metairie, Louisiana, 70006
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215
Delta Research Partners, LLC
Monroe, Louisiana, 71201
Quality Medical Research, PLLC
Nashville, Tennessee, 37211
Yale University Section of Digestive Diseases and Liver Diseases
New Haven, Connecticut, 06520
Deaconess Clinic- Gateway
Newburgh, Indiana, 47630
DM Clinical Research- Southwest Gastroenterology
Oak Lawn, Illinois, 60453
Focilmed
Oxnard, California, 93030
Desert Oasis Healthcare Medical Group
Palm Springs, California, 92262
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Capitol Research
Rockville, Maryland, 20850
Louisiana Research Center
Shreveport, Louisiana, 71103
Virginia Gastroenterology Institute
Suffolk, Virginia, 23434
Wilmington Gastroenterology Associates
Wilmington, North Carolina, 28403
Comprehensive Internal Medicine, Inc.
Wooster, Ohio, 44691
Family Practice Center of Wooster, Inc./Clinical Trial Developers
Wooster, Ohio, 45150
About this study
Official title: Blood Collection Sub-Study of Exact Sciences Protocol 2018-10: "An Evaluation of a Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now"
The primary objective of this sub-study, 2018-10B, is to collect blood specimens to assess new biomarkers for the detection of Colorectal Cancer (CRC).
Read the detailed description
Subjects who consent to enroll in Exact Sciences Protocol 2018-10, will be asked to participate in this sub-study. Subjects enrolled in the Exact Sciences Protocol 2018-10, who provide written informed consent to participate in this sub-study, will have a blood sample collected at enrollment.
- Conditions
- Colo-rectal Cancer
- Being tested
- Blood Sample Collection
- Keywords
- Blood Draw
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Sample CollectionOther
Subjects participating in the study will have blood drawn at enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Subject aged 45-49 with Average CRC Risk | Subjects will be men and women, 45-49 years of age, who enroll in Exact Sciences Protocol 2018-10. Subjects will provide a blood sample at time of enrollment. Receives: Other: Blood Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood-based biomarkers associated with genetic and epigenetic alterations.
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects at average risk for development of colorectal cancer.
Measured: Point in time blood collection (1 day) at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start8 Nov 2018
- Primary completion5 Apr 2019
- Study completion5 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 871 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exact Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Imperiale, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741166
- Sponsor's protocol ID
- 2018-10B
- Status last verified
- May 2021
- First submitted
- 31 Oct 2018
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in publications of the study will be shared after de-identification. This may include text, tables, figured, and appendices. The study protocol and informed consent form will also be shared. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Collection Sub-Study of Exact Sciences Protocol 2018-10: "An Evaluation of a Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now"
- ClinicalTrials.gov ID
- NCT03741166
- Acronym / sponsor ID
- 2018-10B
- Conditions
- Colo-rectal Cancer
- Keywords
- Blood Draw
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 871 participants (actual)
- Lead sponsor
- Exact Sciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this sub-study, 2018-10B, is to collect blood specimens to assess new biomarkers for the detection of Colorectal Cancer (CRC).
Detailed description
Subjects who consent to enroll in Exact Sciences Protocol 2018-10, will be asked to participate in this sub-study. Subjects enrolled in the Exact Sciences Protocol 2018-10, who provide written informed consent to participate in this sub-study, will have a blood sample collected at enrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject aged 45-49 with Average CRC Risk | – | Other: Blood Sample CollectionSubjects will be men and women, 45-49 years of age, who enroll in Exact Sciences Protocol 2018-10. Subjects will provide a blood sample at time of enrollment. |
Who may qualify
- Ages
- 45 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects will be men and women, 45-49 years of age, who enroll in Exact Sciences Protocol 2018-10. Up to 942 subjects will be enrolled.
Key inclusion criteria (3 listed)
- Subject is currently enrolled in Exact Sciences Protocol 2018-10
- Subject is willing and able to provide a blood sample.
- Subject is willing and able to sign informed consent.
Key exclusion criteria (1 listed)
- 1. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Sample CollectionSubjects participating in the study will have blood drawn at enrollment. | Other | Subject aged 45-49 with Average CRC Risk |
Primary outcome
Blood-based biomarkers associated with genetic and epigenetic alterations.
Time frame: Point in time blood collection (1 day) at enrollment
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects at average risk for development of colorectal cancer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in publications of the study will be shared after de-identification. This may include text, tables, figured, and appendices. The study protocol and informed consent form will also be shared. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Imperiale principal investigator
Indiana University
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colo-rectal Cancer, run by Exact Sciences Corporation at 37 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood-based biomarkers associated with genetic and epigenetic alterations. (time frame: Point in time blood collection (1 day) at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2021.