Colorectal CancerNCT03728348
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
An observational study of Colorectal Cancer, run by Exact Sciences Corporation at 39 sites in United States.
Trial summary
The primary objective is to confirm the specificity of a multi-target stool DNA test (mt-sDNA), Cologuard, in an average risk population, ages 45-49. Read more about this study
- Who is it for?
- Ages 45 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- mt-sDNA screening test and Colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 983 participants
- Where
- 39 sitesUnited States
- Study dates
- 6 Nov 2018to 18 Jun 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45-49 years of age who are at average risk for development of CRC. 942 subjects are targeted to enroll.
Who may be able to join
- Subjects must meet the following criteria to be eligible for the study:
- Subject is at average risk for development of CRC.
- Subject is able and willing to undergo a screening colonoscopy.
- Subject is ≥ 45 and ≤ 49 years of age at the time of enrollment.
- Subject is willing and able to sign informed consent.
- Subject is able and willing to provide stool sample(s) according to written instructions provided.
Who cannot join
- Subject has a history of CRC or adenoma.
- Subject has ≥2 first-degree relatives who have been diagnosed with CRC
- Subject has one first-degree relative with CRC diagnosed before the age of 60.
- Subject has any of the following: Overt rectal bleeding, e.g., hematochezia or melena within the previous 30 days (blood on toilet paper, after wiping, does not constitute rectal bleeding). Positive fecal occult blood test or FIT within the previous six (6) months. Subject has had a previous colonoscopy. Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years.
- Subject has a diagnosis or personal 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 and Familial Hyperplastic Polyposis.
- Subject has a family history of: Familial adenomatous polyposis (also referred to as "FAP"), Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
Show all 11Show fewer
- Subjects with Cronkhite-Canada Syndrome.
- Subject has a diagnosis of inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.
- Subject has a history of aerodigestive tract cancer.
- Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease.
- Subject has any condition that in the opinion of the investigator should preclude participation in the study.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 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
Indiana University, Eskanazi Hospital
Indianapolis, Indiana, 46202
Alliance Research Centers
Laguna Hills, California, 92653
Precision Clinical Research, LLC
Lauderdale Lakes, Florida, 33319
Johnson County ClinTrials, LLC
Lenexa, Kansas, 66219
Family Practice Center of Wooster, Inc./Clinical Trial Developers
Massillon, Ohio, 44647
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060
New Orleans Research Institute
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
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
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
About this study
The primary objective is to confirm the specificity of a multi-target stool DNA test (mt-sDNA), Cologuard, in an average risk population, ages 45-49.
Read the detailed description
Subjects aged 45-49 at average risk for development of CRC will be enrolled. Subjects will complete the mt-sDNA screening test (Cologuard) followed by completion of a screening colonoscopy. The results of the mt-sDNA screening test (Cologuard) will not be provided to investigators for clinical management of study subjects. Personnel performing the colonoscopy and producing the resulting report and personnel performing histopathological review of tissue (if applicable) will remain blinded to the results of the mt-sDNA screening test (Cologuard) result.
- Conditions
- Colorectal Cancer
- Being tested
- mt-sDNA screening test, Colonoscopy
- Keywords
- Sample Collection, Stool DNA, Colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mt-sDNA screening testDiagnostic test
Also called Cologuard
Stool samples will be collected by the subject for the mt-sDNA screening test.
ColonoscopyProcedure or surgery
Subjects will undergo a screening colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Subject aged 45-49 with Average CRC Risk | Subject aged 45-49 with average risk for development of CRC. Receives: Diagnostic Test: mt-sDNA screening test; Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity of the Multi-target Stool DNA Test in Average Risk Population, Ages 45-49
An optical colonoscopic procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. Results were generated with the use of a logistic-regression algorithm, with values of 183 or more considered to be positive. Tests were processed independently of colonoscopic findings. The test functions as a screening tool by generating a score, based on the detection of hemoglobin and multiple DNA methylation and mutational markers, together with an assessment of the total amount of human DNA in each sample. Specificity =100*(multi-target stool DNA test negative/negative colonoscopy)
Measured: Through study completion, an average of 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start6 Nov 2018
- Primary completion18 Jun 2019
- Study completion18 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal 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
- 983 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exact Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Imperiale, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728348
- Sponsor's protocol ID
- 2018-10
- Status last verified
- Jun 2021
- First submitted
- 31 Oct 2018
- Last updated
- 4 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- 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, figures, and appendices. The study protocol, statistical analysis plan, informed consent form, and clinical study report 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.
Publications
Imperiale TF, Kisiel JB, Itzkowitz SH, Scheu B, Duimstra EK, Statz S, Berger BM, Limburg PJ. Specificity of the Multi-Target Stool DNA Test for Colorectal Cancer Screening in Average-Risk 45-49 Year-Olds: A Cross-Sectional Study. Cancer Prev Res (Phila). 2021 Apr;14(4):489-496. doi: 10.1158/1940-6207.CAPR-20-0294. Epub 2021 Jan 12.
PubMed 33436397
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- NCT03728348
- Acronym / sponsor ID
- 2018-10
- Conditions
- Colorectal Cancer
- Keywords
- Sample Collection, Stool DNA, Colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 983 participants (actual)
- Lead sponsor
- Exact Sciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 18 Jun 2019 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 2 Nov 2018 (actual)
- Results
- Posted 4 Jun 2021
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 is to confirm the specificity of a multi-target stool DNA test (mt-sDNA), Cologuard, in an average risk population, ages 45-49.
Detailed description
Subjects aged 45-49 at average risk for development of CRC will be enrolled. Subjects will complete the mt-sDNA screening test (Cologuard) followed by completion of a screening colonoscopy. The results of the mt-sDNA screening test (Cologuard) will not be provided to investigators for clinical management of study subjects. Personnel performing the colonoscopy and producing the resulting report and personnel performing histopathological review of tissue (if applicable) will remain blinded to the results of the mt-sDNA screening test (Cologuard) result.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject aged 45-49 with Average CRC Risk | – | Diagnostic Test: mt-sDNA screening test, Procedure: ColonoscopySubject aged 45-49 with average risk for development of CRC. |
Who may qualify
- Ages
- 45 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects 45-49 years of age who are at average risk for development of CRC. 942 subjects are targeted to enroll.
Key inclusion criteria (6 listed)
- Subject is at average risk for development of CRC.
- Subject is able and willing to undergo a screening colonoscopy.
- Subject is ≥ 45 and ≤ 49 years of age at the time of enrollment.
- Subject is willing and able to sign informed consent.
- Subject is able and willing to provide stool sample(s) according to written instructions provided.
Key exclusion criteria (11 listed)
- Subject has a history of CRC or adenoma.
- Subject has ≥2 first-degree relatives who have been diagnosed with CRC
- Subject has one first-degree relative with CRC diagnosed before the age of 60.
- Subject has any of the following: Overt rectal bleeding, e.g., hematochezia or melena within the previous 30 days (blood on toilet paper, after wiping, does not constitute rectal bleeding). Positive fecal occult blood test or FIT within the previous six (6) months. Subject has had a previous colonoscopy. Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years.
- Subject has a diagnosis or personal 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 and Familial Hyperplastic Polyposis.
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 |
|---|---|---|
| mt-sDNA screening testAlso: CologuardStool samples will be collected by the subject for the mt-sDNA screening test. | Diagnostic test | Subject aged 45-49 with Average CRC Risk |
| ColonoscopySubjects will undergo a screening colonoscopy. | Procedure or surgery | Subject aged 45-49 with Average CRC Risk |
Primary outcome
Specificity of the Multi-target Stool DNA Test in Average Risk Population, Ages 45-49
Time frame: Through study completion, an average of 60 days
An optical colonoscopic procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. Results were generated with the use of a logistic-regression algorithm, with values of 183 or more considered to be positive. Tests were processed independently of colonoscopic findings. The test functions as a screening tool by generating a score, based on the detection of hemoglobin and multiple DNA methylation and mutational markers, together with an assessment of the total amount of human DNA in each sample. Specificity =100*(multi-target stool DNA test negative/negative colonoscopy)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33436397Imperiale TF, Kisiel JB, Itzkowitz SH, Scheu B, Duimstra EK, Statz S, Berger BM, Limburg PJ. Specificity of the Multi-Target Stool DNA Test for Colorectal Cancer Screening in Average-Risk 45-49 Year-Olds: A Cross-Sectional Study. Cancer Prev Res (Phila). 2021 Apr;14(4):489-496. doi: 10.1158/1940-6207.CAPR-20-0294. Epub 2021 Jan 12.
- 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, figures, and appendices. The study protocol, statistical analysis plan, informed consent form, and clinical study report 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, MD principal investigator
Indiana University
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Exact Sciences Corporation at 39 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 6 inclusion and 11 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 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 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?
Yes. Results are posted in the registry (first posted 4 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Specificity of the Multi-target Stool DNA Test in Average Risk Population, Ages 45-49 (time frame: Through study completion, an average of 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03728348, which also lists 1 linked publication.
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 4 Jun 2021.