Colorectal CancerNCT03789162
Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast
An observational study of Colorectal Cancer, run by Exact Sciences Corporation at 45 sites in 2 countries.
Trial summary
The primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for the detection of colorectal cancer (CRC). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 850 participants
- Where
- 45 sitesin 2 countries
- Study dates
- 20 Dec 2018to 29 May 2025
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 1500 subjects will be enrolled. Participants will be 40 years of age or older, with a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy, sigmoidoscopy, or computed tomography (CT) colonography.
Who may be able to join
- Participant is 40 years of age or older.
- Participant has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy, sigmoidoscopy, or CT colonography.
- Postcolonoscopy, the residual lesion in the colon must be at least 1 cm in size as to require additional surgical excision or complex colonoscopic polypectomy.
- Participant understands the study procedures and is able to provide informed consent to take part in the study and authorization for release of relevant protected health information to the study Investigator.
Who cannot join
- Any previous cancer diagnosis (with the exceptions of basal cell or squamous cell skin cancers) and/or cancer related treatment (e.g., chemotherapy, immunotherapy, radiation, and/or surgery) within the past 5 years.
- Less than 7 days between colonoscopy and blood and/or stool specimen collection.
- IV contrast (e.g., CT or MRI) within 1 day [or 24 hours] before blood and/or stool collection.
- Participant has any condition that in the opinion of the Investigator should preclude taking part in the study.
Trial locations and contacts
45 sites in 2 countries.
45 sites in 2 countries
United States44 sites
Digestive Health Partners, PA
Asheville, North Carolina, 28801
Clinical Trials Network
Beachwood, Ohio, 44122
University Health Service Hospitals, Inc.
Binghamton, New York, 13903
Susquehanna Research Group
Camp Hill, Pennsylvania, 17011
Alliance Research Institute
Canoga Park, California, 91304
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte, North Carolina, 28207
Rush University Medical Center
Chicago, Illinois, 60612
GW Research Inc
Chula Vista, California, 91910
Northside Gastroenterology Associates PA
Cypress, Texas, 77429
Deaconess Clinic, Inc.
Evansville, Indiana, 47713
Gastroenterology Associates of Fairfield County, P.C.
Fairfield, Connecticut, 06824
HSHS St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301
Connecticut Clinical Research Institute
Hartford, Connecticut, 06016
Digestive Health Research, LLC
Hermitage, Tennessee, 37076
Digestive Health
Houston, Texas, 77024
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
The Jackson Clinic Professional Association
Jackson, Tennessee, 38305
Tilda Research
Laguna Hills, California, 92653
Blue Ridge Medical Research
Lynchburg, Virginia, 24502
Virtua Health Inc
Marlton, New Jersey, 08053
Clinical Trials Network
Mentor, Ohio, 44060
MZS Research, LLC
Metairie, Louisiana, 70001
Delta Research Partners
Monroe, Louisiana, 71201
Yale University
New Haven, Connecticut, 06520
Icahn School of Medicine at Mount Sinai Beth Israel
New York, New York, 10003
DM Clinical Research/Southwest Gastroenterology
Oak Lawn, Illinois, 60453
Mayo Clinic - Arizona
Phoenix, Arizona, 85054
Capitol Research
Rockville, Maryland, 20850
HealthPartners Institute
Saint Louis Park, Minnesota, 55425
Park Nicollet Oncology Research
Saint Louis Park, Minnesota, 55426
Clinical Trials Network
San Diego, California, 92103
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105
Digestive Research Alliance of Michiana, LLC
South Bend, Indiana, 46635
Spartanburg Regional Health Services District, Inc
Spartanburg, South Carolina, 29303
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Virginia Gastroenterology Institute
Suffolk, Virginia, 23434
MultiCare Institute for Research & Innovation - Tacoma
Tacoma, Washington, 98405
Guardian Angel Research Center
Tampa, Florida, 33614
Texarkana Clinical Research
Texarkana, Texas, 75503
Advanced Gastroenterology
Union City, Tennessee, 38261
Frontier Clinical Research, LLC
Uniontown, Pennsylvania, 15401
Carle Foundation Hospital dba Carle Cancer Center
Urbana, Illinois, 61801
Clinical Trials of America, LLC
West Monroe, Louisiana, 71291
Trial Management Associates, LLC
Wilmington, North Carolina, 28403
Canada1 site
University of Clagary, Forzani & MacPhail Colon Cancer Screening Centre
Calgary, Alberta, T2N 1N4
About this study
The primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for the detection of colorectal cancer (CRC).
Read the detailed description
Participants will be 40 years of age or older, with a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy, sigmoidoscopy, or computed tomography (CT) colonography. Approximately 1500 participants will be enrolled.
- Conditions
- Colorectal Cancer
- Keywords
- Blood Draw, Sample Collection, Stool DNA
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Confirmed CRC with Residual Lesion | A diagnosis of CRC confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool-based biomarkers associated with genetic and epigenetic alterations
The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in stool from subjects with confirmed colorectal cancer at the pre-intervention stage.
Measured: Stool sample will be collected at least 7 days after the subject's pre-enrollment colonoscopy, but prior to initiation of bowel preparation for any follow-up procedure
Blood-based biomarkers associated with genetic and epigenetic alterations
The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with confirmed colorectal cancer at the pre-intervention stage.
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 posted28 Dec 2018
- Study start20 Dec 2018
- Primary completion31 Mar 2025
- Study completion29 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exact Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789162
- Sponsor's protocol ID
- 2018-07
- Status last verified
- Jun 2025
- First submitted
- 18 Dec 2018
- Last updated
- 29 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast
- ClinicalTrials.gov ID
- NCT03789162
- Acronym / sponsor ID
- 2018-07
- Conditions
- Colorectal Cancer
- Keywords
- Blood Draw, Sample Collection, Stool DNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- Exact Sciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 28 Dec 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 study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for the detection of colorectal cancer (CRC).
Detailed description
Participants will be 40 years of age or older, with a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy, sigmoidoscopy, or computed tomography (CT) colonography. Approximately 1500 participants will be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Confirmed CRC with Residual Lesion | – | –A diagnosis of CRC confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 1500 subjects will be enrolled. Participants will be 40 years of age or older, with a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy, sigmoidoscopy, or computed tomography (CT) colonography.
Key inclusion criteria (4 listed)
- Participant is 40 years of age or older.
- Participant has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy, sigmoidoscopy, or CT colonography.
- Postcolonoscopy, the residual lesion in the colon must be at least 1 cm in size as to require additional surgical excision or complex colonoscopic polypectomy.
- Participant understands the study procedures and is able to provide informed consent to take part in the study and authorization for release of relevant protected health information to the study Investigator.
Key exclusion criteria (4 listed)
- Any previous cancer diagnosis (with the exceptions of basal cell or squamous cell skin cancers) and/or cancer related treatment (e.g., chemotherapy, immunotherapy, radiation, and/or surgery) within the past 5 years.
- Less than 7 days between colonoscopy and blood and/or stool specimen collection.
- IV contrast (e.g., CT or MRI) within 1 day [or 24 hours] before blood and/or stool collection.
- Participant has any condition that in the opinion of the Investigator should preclude taking part 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.
Primary outcome
Stool-based biomarkers associated with genetic and epigenetic alterations
Time frame: Stool sample will be collected at least 7 days after the subject's pre-enrollment colonoscopy, but prior to initiation of bowel preparation for any follow-up procedure
The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in stool from subjects with confirmed colorectal cancer at the pre-intervention stage.
Blood-based biomarkers associated with genetic and epigenetic alterations
Time frame: Point in time blood collection (1 day) at enrollment
The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with confirmed colorectal cancer at the pre-intervention stage.
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 29 Jun 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
45 sites in 2 countries: 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 45 sites in 2 countries.
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 4 inclusion and 4 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 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Canada. 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?
Stool-based biomarkers associated with genetic and epigenetic alterations (time frame: Stool sample will be collected at least 7 days after the subject's pre-enrollment colonoscopy, but prior to initiation of bowel preparation for any follow-up procedure). The study lists 2 primary outcomes in all. 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 29 Jun 2025.