Colorectal NeoplasmsNCT01260168
Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies
An observational study of Colorectal Neoplasms and Digestive System Diseases, run by Exact Sciences Corporation at 21 sites in 2 countries.
Trial summary
The objective of this study is to confirm the sensitivity of a stool DNA test for detection of colorectal cancer and pre-cancer. Another objective is to provide anonymous, clinically characterized specimens for a bio-repository for future colorectal cancer-related test development. 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
- How many people
- 435 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Oct 2010to Nov 2013
- 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: Patients who have had colorectal cancer or pre-malignancy confirmed by colonoscopic biopsy-based diagnosis.
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 and/or ≥1 cm colorectal polyp/adenoma/mass identified on a colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy.
- 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
- Subject has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer).
- Subject has a history of any inflammatory bowel disease.
- Subject has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch) syndrome, or other hereditary cancer syndromes.
- 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
21 sites in 2 countries.
21 sites in 2 countries
United States20 sites
Asheville Gastroenterology
Asheville, North Carolina, 28801
Atlanta Gastroenterology
Atlanta, Georgia, 30308
Gastroenterology Associates
Baton Rouge, Louisiana, 70809
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216
Commonwealth Clinical Studies
Brockton, Massachusetts, 02302
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Jesse Brown VA
Chicago, Illinois, 60612
Rush University Gastroenterologists
Chicago, Illinois, 60612
Stroger Cook County
Chicago, Illinois, 60612
University of Illinois at Chicago
Chicago, Illinois, 60612
Gastro One
Germantown, Tennessee, 38138
Long Island Gastrointestinal Group
Great Neck, New York, 11023
Clinical Research Associates
Huntsville, Alabama, 35801
Southern Gastroenterology Associates
New Bern, North Carolina, 28562
Mount Sinai School of Medicine
New York, New York, 10029
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502
Northwest Gastroenterology Clinic, LLC
Portland, Oregon, 97208
Rockford Gastroenterology Associates, Ltd
Rockford, Illinois, 61107
University of Utah
Salt Lake City, Utah, 84132
Digestive Health Specialists
Tyler, Texas, 75701
About this study
The objective of this study is to confirm the sensitivity of a stool DNA test for detection of colorectal cancer and pre-cancer.
Another objective is to provide anonymous, clinically characterized specimens for a bio-repository for future colorectal cancer-related test development.
Read the detailed description
Patients who have been recently diagnosed with colo-rectal cancer or pre-cancer will be asked to submit a stool sample(s)(at least 7 days AFTER colonoscopy) and will have the option of submitting blood and tissue samples for future colo-rectal cancer-related test development.
- 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.
| 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 an intact pre-malignant colorectal lesion large enough to require surgical excision or complex colonoscopic polypectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms.
The diagnostic test under development is a multi-marker stool test for detecting CRC and pre-cancer in a general screening application. The primary objective of this study is to confirm the sensitivity of the optimal DNA marker panel.
Measured: 12 Months
Secondary outcomes (1)
To collect samples from patients diagnosed with colorectal cancers.
Residual samples from patients diagnosed with colorectal cancer will be archived for further research intended to help in the diagnosis of cancers. Specimens will be stored up to 10 years in the Sponsor's on-site bio-repository or similar commercial bio-repository contracted by the sponsor.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exact Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Graham Lidgard, PhD, Study chair, Chief Scientific Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260168
- Sponsor's protocol ID
- Exact Sciences 2010-A
- Status last verified
- May 2015
- First submitted
- 6 Dec 2010
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lidgard GP, Domanico MJ, Bruinsma JJ, Light J, Gagrat ZD, Oldham-Haltom RL, Fourrier KD, Allawi H, Yab TC, Taylor WR, Simonson JA, Devens M, Heigh RI, Ahlquist DA, Berger BM. Clinical performance of an automated stool DNA assay for detection of colorectal neoplasia. Clin Gastroenterol Hepatol. 2013 Oct;11(10):1313-8. doi: 10.1016/j.cgh.2013.04.023. Epub 2013 Apr 29.
PubMed 23639600
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies
- ClinicalTrials.gov ID
- NCT01260168
- Acronym / sponsor ID
- Exact Sciences 2010-A
- Keywords
- Cancer, Colorectal Cancer, Neoplasm, Colorectal Neoplasm, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- Exact Sciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 15 Dec 2010 (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 objective of this study is to confirm the sensitivity of a stool DNA test for detection of colorectal cancer and pre-cancer.
Another objective is to provide anonymous, clinically characterized specimens for a bio-repository for future colorectal cancer-related test development.
Detailed description
Patients who have been recently diagnosed with colo-rectal cancer or pre-cancer will be asked to submit a stool sample(s)(at least 7 days AFTER colonoscopy) and will have the option of submitting blood and tissue samples for future colo-rectal cancer-related test development.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 an intact pre-malignant colorectal lesion large enough to require 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
- Patients who have had colorectal cancer or pre-malignancy confirmed by colonoscopic biopsy-based diagnosis.
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 and/or ≥1 cm colorectal polyp/adenoma/mass identified on a colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy.
- 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 (4 listed)
- Subject has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer).
- Subject has a history of any inflammatory bowel disease.
- Subject has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch) syndrome, or other hereditary cancer syndromes.
- 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.
Primary outcome
The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms.
Time frame: 12 Months
The diagnostic test under development is a multi-marker stool test for detecting CRC and pre-cancer in a general screening application. The primary objective of this study is to confirm the sensitivity of the optimal DNA marker panel.
1 secondary outcome
To collect samples from patients diagnosed with colorectal cancers.
Time frame: 12 Months
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 13 May 2015.
- Results publication: PubMed 23639600Lidgard GP, Domanico MJ, Bruinsma JJ, Light J, Gagrat ZD, Oldham-Haltom RL, Fourrier KD, Allawi H, Yab TC, Taylor WR, Simonson JA, Devens M, Heigh RI, Ahlquist DA, Berger BM. Clinical performance of an automated stool DNA assay for detection of colorectal neoplasia. Clin Gastroenterol Hepatol. 2013 Oct;11(10):1313-8. doi: 10.1016/j.cgh.2013.04.023. Epub 2013 Apr 29.
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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.
Graham Lidgard, PhD study chair
Chief Scientific Officer
21 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 21 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 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 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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?
The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms. (time frame: 12 Months). 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 NCT01260168, 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 13 May 2015.