Colorectal CancerNCT03821948
Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold
An observational study of Colorectal Cancer, run by Exact Sciences Corporation at 40 sites in United States.
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 detection of colorectal cancer (CRC). Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- How many people
- 5,131 participants
- Where
- 40 sitesUnited States
- Study dates
- 3 Jan 2019to 15 May 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be men and women, 40 years of age or older who are scheduled for a colonoscopy. Approximately 7,500 subjects will be enrolled.
Who may be able to join
- Subject is male or female, 40 years of age or older.
- Subject is at average or increased risk for development of CRC.
- Subject presents for screening or surveillance colonoscopy.
- Subject has no symptoms that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
- 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.
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.
- 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:
Show all 11Show fewer
- Familial adenomatous polyposis (also referred to as "FAP").
- Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
- Subjects with Cronkhite-Canada Syndrome.
- IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
- Subject has any condition that in the opinion of the Investigator should preclude participation in the study
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Digestive Health Partners, PA
Asheville, North Carolina, 28801
MediSync Clinical Research
Austin, Texas, 78726
Margaret Mary Health
Batesville, Indiana, 47006
Great Lakes Medical Research
Beachwood, Ohio, 44122
Charlotte Gastroenterology and Hepatology, LLC
Charlotte, North Carolina, 28207
GW Research, Inc
Chula Vista, California, 91910
Northside Gastroenterology
Cypress, Texas, 77429
Great Lakes Medical Research, LLC
East Lansing, Michigan, 48823
AGA Clinical Research Associates, LLC
Egg Harbor, New Jersey, 08234
Centennial Medical Group
Elkridge, Maryland, 21075
Great Lakes Medical Research
Erie, Pennsylvania, 16506
Deaconess Clinic-Mt. Pleasant
Evansville, Indiana, 47725
Susquehanna Research Group
Harrisburg, Pennsylvania, 17110
Connecticut Clinical Research Institute, LLC
Hartford, Connecticut, 06016
Vilo Research Group, Inc
Houston, Texas, 77017
Digestive Health Associates
Houston, Texas, 77024
Marvel Research, LLC
Huntington Beach, California, 92647
Blue Ridge Medical Research
Lynchburg, Virginia, 24502
DM Clinical Research/PCP For Life
Magnolia, Texas, 77355
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
Delta Research Partners
Monroe, Louisiana, 71201
Yale University
New Haven, Connecticut, 06520
Digestive Disease Care, PC
New Hyde Park, New York, 11040
Deaconess Clinic-Gateway
Newburgh, Indiana, 47630
DM Clinical Research/Southwest Gastroenterology
Oak Lawn, Illinois, 60453
Desert Medical Group Inc
Palm Springs, California, 92262
Mayo Clinic
Rochester, Minnesota, 55905
Capitol Research
Rockville, Maryland, 20850
Great Lakes Medical Research, LLC
San Diego, California, 92103
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105
Virginia Gastroenterology Institute
Suffolk, Virginia, 23434
Guardian Angel Research Center
Tampa, Florida, 33614
CCT Research/Fiel Family and Sports Medicine
Tempe, Arizona, 85283
Great Lakes Medical Research, LLC
Union City, Tennessee, 38261
Wenatchee Valley Hospital
Wenatchee, Washington, 98801
Great Lakes Medical Research, LLC
Westlake, Ohio, 44145
Trial Management Associates, LLC
Wilmington, North Carolina, 28403
Comprehensive Internal Medicine, Inc
Wooster, Ohio, 44691
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 detection of colorectal cancer (CRC).
Read the detailed description
Subjects will be men and women, 40 years of age or older who are scheduled for a colonoscopy. Approximately 7,500 subjects 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 |
|---|---|---|
| Average CRC Risk Group | Stool sample collection and blood draw in men and women aged 40 and older with average CRC risk undergoing a standard of care colonoscopy procedure | |
| Increased CRC Risk Group | Stool sample collection and blood draw in men and women aged 40 and older with increased CRC risk undergoing a standard of care colonoscopy procedure |
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 at average risk or increased risk for development of colorectal cancer at the pre-intervention stage.
Measured: Stool sample will be collected prior to initiation of bowel preparation for colonoscopy.
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 at average risk or increased risk for development of 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 posted30 Jan 2019
- Study start3 Jan 2019
- Primary completion28 Feb 2020
- Study completion15 May 2020
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
- 5,131 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
- NCT03821948
- Sponsor's protocol ID
- 2018-08
- Status last verified
- Jul 2020
- First submitted
- 16 Jan 2019
- Last updated
- 21 Jul 2020
- Results posted
- 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 deidentification. This may include text, tables, figures and appendices. The study protocol and informed consent form will also be shared.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold
- ClinicalTrials.gov ID
- NCT03821948
- Acronym / sponsor ID
- 2018-08
- Conditions
- Colorectal Cancer
- Keywords
- Blood Draw, Sample Collection, Stool DNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,131 participants (actual)
- Lead sponsor
- Exact Sciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 30 Jan 2019 (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 detection of colorectal cancer (CRC).
Detailed description
Subjects will be men and women, 40 years of age or older who are scheduled for a colonoscopy. Approximately 7,500 subjects will be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Average CRC Risk Group | – | –Stool sample collection and blood draw in men and women aged 40 and older with average CRC risk undergoing a standard of care colonoscopy procedure |
| Increased CRC Risk Group | – | –Stool sample collection and blood draw in men and women aged 40 and older with increased CRC risk undergoing a standard of care colonoscopy procedure |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be men and women, 40 years of age or older who are scheduled for a colonoscopy. Approximately 7,500 subjects will be enrolled.
Key inclusion criteria (5 listed)
- Subject is male or female, 40 years of age or older.
- Subject is at average or increased risk for development of CRC.
- Subject presents for screening or surveillance colonoscopy.
- Subject has no symptoms that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
- 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.
Key exclusion criteria (11 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.
- Subject has a diagnosis or personal history of any of the following conditions, including:
- Subject has a family history of:
- Subjects with Cronkhite-Canada Syndrome.
- IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
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 prior to initiation of bowel preparation for colonoscopy.
The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in stool from subjects at average risk or increased risk for development of 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 at average risk or increased risk for development of 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 21 Jul 2020.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures and appendices. The study protocol and informed consent form will also be shared.
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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.
40 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 40 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 5 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 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 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?
Stool-based biomarkers associated with genetic and epigenetic alterations (time frame: Stool sample will be collected prior to initiation of bowel preparation for colonoscopy.). 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 21 Jul 2020.