Colorectal NeoplasmsNCT02503631
Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers
An observational study of Colorectal Neoplasms and Digestive System Diseases, run by Exact Sciences Corporation at 22 sites in 2 countries.
Trial summary
The primary objective of this study is to obtain de-identified, clinically characterized, stool and plasma specimens for use in assessing new markers for the detection of neoplasms of the digestive tract. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Colorectal Neoplasms, Digestive System Diseases, Colonic Diseases
- What is being tested?
- Stool Sample Collection Kit
- Type of treatment
- Medical device
- How many people
- 397 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Oct 2014to Sep 2017
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of CRC and/or a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy.
Who may be able to join
- Subject is male or female, 40-90 years of age, inclusive.
- Subject has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or colorectal polyp/adenoma/mass that is equal or larger than 1 cm in pre-enrollment colonoscopy with residual lesion in the colon of sufficient size to require additional surgical excision or complex colonoscopic polypectomy.
- Subject understands the study procedures and is able to provided informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Who cannot join
- Subject has actively bleeding hemorrhoids (blood on toilet paper or bright red blood clots in the toilet bowel during bowel movement).
- 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.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States21 sites
Radiant Research, Inc.
Anderson, South Carolina, 29621
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, 28801
Commonwealth Clinical Studies
Brockton, Massachusetts, 02302
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Rush University Medical Center
Chicago, Illinois, 60612
DBA Boone Hospital Center
Columbia, Missouri, 65201
Cumberland Research Associates, LLC
Fayetteville, North Carolina, 28304
Gastro One
Germantown, Tennessee, 38138
Medical Research Center of Connecticut
Hamden, Connecticut, 06518
Gulf Coast Research Group, LLC
Holiday, Florida, 34691
Blue Ridge Medical Researcj
Lynchburg, Virginia, 24502
Main Line Gastroenterology Associates
Malvern, Pennsylvania, 19355
Colon and Rectal Surgery Associates
Metairie, Louisiana, 70001
New Orleans Research Institute
Metairie, Louisiana, 70006
John D. Homan, MD
Newport Beach, California, 92663
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114
Endoscopic Research, Inc.
Orlando, Florida, 32803
Northwest Gastroenterology Clinic, LLC
Portland, Oregon, 97210
Louisiana Research Center, LLC
Shreveport, Louisiana, 71103
Sundance Clinical Research, LLC
St Louis, Missouri, 63141
Canada1 site
Forzani & MacPhali Colon Cancer Screening Centre
Calgary, Alberta, T2N 4Z6
About this study
The primary objective of this study is to obtain de-identified, clinically characterized, stool and plasma specimens for use in assessing new markers for the detection of neoplasms of the digestive tract.
Read the detailed description
This is a multi-site, prospective sample collection study. Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of CRC and/or a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy.
One stool sample from approximately 300 subjects will be collected in this study. A blood sample will also be collected from subjects.
- Being tested
- Stool Sample Collection Kit
- Keywords
- Cancer, Colorectal Cancer, Neoplasm, Colorectal Neoplasm, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Intestinal Diseases, Rectal Diseases
- Medical subject headings
- Colorectal Neoplasms, Digestive System Diseases, Colonic Diseases, Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool Sample Collection KitDevice
Stool sample collection kit
| Study group | Role | What they receive |
|---|---|---|
| Colorectal cancer patients | Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of colorectal cancer (CRC) and/or a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy. Receives: Device: Stool Sample Collection Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide stool and blood specimens to assess new markers for the detection of CRC
Measured: 33 months
Secondary outcomes (3)
To provide stool and blood specimens for use as controls when assessing new markers for the detection of neoplasms in other locations within the digestive tract (esophagus, stomach, pancreas, etc.)
Measured: 33 months
To provide stool and blood specimens for a biorepository for future cancer-related diagnostic test development
Measured: 33 months
To provide quality control material for use in assessing performance of developed assays
Measured: 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startOct 2014
- Primary completionMar 2017
- Study completionSep 2017
Why it stopped: Changes in development plan
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exact Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Domanico, Study chair, Exact Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503631
- Sponsor's protocol ID
- 2014-02
- Status last verified
- Apr 2018
- First submitted
- 17 Jul 2015
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers
- ClinicalTrials.gov ID
- NCT02503631
- Acronym / sponsor ID
- 2014-02
- Keywords
- Cancer, Colorectal Cancer, Neoplasm, Colorectal Neoplasm, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Changes in development plan
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Exact Sciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 21 Jul 2015 (estimated)
- 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 obtain de-identified, clinically characterized, stool and plasma specimens for use in assessing new markers for the detection of neoplasms of the digestive tract.
Detailed description
This is a multi-site, prospective sample collection study. Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of CRC and/or a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy.
One stool sample from approximately 300 subjects will be collected in this study. A blood sample will also be collected from subjects.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer patients | – | Device: Stool Sample Collection KitSubjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of colorectal cancer (CRC) and/or a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of CRC and/or a pre-malignant colorectal lesion with large enough residual lesion to require subsequent surgical excision or complex colonoscopic polypectomy.
Key inclusion criteria (3 listed)
- Subject is male or female, 40-90 years of age, inclusive.
- Subject has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or colorectal polyp/adenoma/mass that is equal or larger than 1 cm in pre-enrollment colonoscopy with residual lesion in the colon of sufficient size to require additional surgical excision or complex colonoscopic polypectomy.
- Subject understands the study procedures and is able to provided informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Key exclusion criteria (2 listed)
- Subject has actively bleeding hemorrhoids (blood on toilet paper or bright red blood clots in the toilet bowel during bowel movement).
- 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.
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 |
|---|---|---|
| Stool Sample Collection KitStool sample collection kit | Device | Colorectal cancer patients |
Primary outcome
To provide stool and blood specimens to assess new markers for the detection of CRC
Time frame: 33 months
3 secondary outcomes
To provide stool and blood specimens for use as controls when assessing new markers for the detection of neoplasms in other locations within the digestive tract (esophagus, stomach, pancreas, etc.)
Time frame: 33 months
To provide stool and blood specimens for a biorepository for future cancer-related diagnostic test development
Time frame: 33 months
To provide quality control material for use in assessing performance of developed assays
Time frame: 33 months
Results and safety
The study was stopped early (reason given: Changes in development plan). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
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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.
Michael Domanico study chair
Exact Sciences
22 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 Neoplasms and Digestive System Diseases, run by Exact Sciences Corporation at 22 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 was stopped early (reason given: Changes in development plan). Results are not available in the source record.
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?
To provide stool and blood specimens to assess new markers for the detection of CRC (time frame: 33 months). 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 6 Apr 2018.