Colorectal NeoplasmsNCT01600209
Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing
An observational study of Colorectal Neoplasms and Digestive System Diseases, run by Exact Sciences Corporation at 13 sites in United States.
Trial summary
The objective of this study is to confirm the sensitivity and specificity of a stool DNA test for detection of colorectal cancer and pre-cancer. Read more about this study
- Who is it for?
- Ages 50 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms, Digestive System Diseases, Colonic Diseases
- How many people
- 674 participants
- Where
- 13 sitesUnited States
- Study dates
- Oct 2011to Sep 2012
- 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 50 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients are at average risk of developing colorectal cancer at the time of their colonoscopy and the colonoscopy resulted in normal findings.
Who may be able to join
- Subject is male or female, 50-84 years of age, inclusive.
- Subject is at average risk for development of CRC and has undergone a screening colonoscopy with a normal result at least 30 days and no more than 120 days before providing a stool sample for the study. For the purposes of this study, a "normal" colonoscopy result is defined as no polyps of any size detected or removed (including benign, hyperplastic polyps).
- Subject is able to understand the study procedures, and is able to provide signed consent to participate in the study and authorizes release of relevant protected health information through signing a HIPAA consent.
- Subject is able and willing to provide stool samples at least 30 days and no more than 120 days after undergoing a colonoscopy that resulted in normal findings, according to the written instructions provided to them.
Who cannot join
- Subject has any condition which, in the opinion of the investigator should preclude participation in the study.
- Subject had any findings on recent or any previous colonoscopy including benign, and/or hyperplastic polyps of any size. (Note: Tissue biopsies that result in no histopathology findings are acceptable.)
- Subject has a history or recent diagnosis of CRC or adenoma.
- Subject has a history of aerodigestive tract cancer.
- Subject has had a positive fecal occult blood test or FIT within the previous six (6) months.
- Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease.
Show all 14Show fewer
- Subject has had overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding)
- Subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer:
- Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.
- Greater than or equal to (>=)2 first-degree relatives who have been diagnosed with colon cancer. (Note: first-degree relatives include parents, siblings and offspring).
- One first-degree relative with CRC diagnosed before the age of 60.
- Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP).
- Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" of "Lynch Syndrome").
- Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Professional Quality Research, Inc.
Austin, Texas, 78705
Columbia Medical Practice
Columbia, Maryland, 21045
Atlanta Gastroenterology Associates
Marietta, Georgia, 30067
New Orleans Research Institue
Metairie, Louisiana, 70006
Miami Research Associates
Miami, Florida, 33173
Advanced Research Institute
Ogden, Utah, 84405
Main Line Gastroenterology
Perkasie, Pennsylvania, 18944
Remek Research
Pomona, California, 91767
Rockford Gastroenterology Associates, LTD.
Rockford, Illinois, 61107
Sharp Rees-Stealy
San Diego, California, 92101
Advanced Research Institute
Sandy City, Utah, 84094
Southern California Medical Gastroenterology Group, Inc
Santa Monica, California, 90404
Desert Sun Clinical Research
Tucson, Arizona, 85710
About this study
The objective of this study is to confirm the sensitivity and specificity of a stool DNA test for detection of colorectal cancer and pre-cancer.
Read the detailed description
Patients who have recently undergone a colonoscopy that resulted with normal findings will be asked to submit a stool sample (s) (at least 30 days AFTER colonoscopy).
- 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 |
|---|---|---|
| Average risk patients | Subjects will be men and women, 50-84 years of age, inclusive, each with a screening colonoscopy resulting in normal findings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of the Exact CRC diagnostic screening test.
The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startOct 2011
- Primary completionAug 2012
- Study completionSep 2012
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
- 674 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
- NCT01600209
- Sponsor's protocol ID
- Exact Sciences 2011-N
- Status last verified
- May 2015
- First submitted
- 11 May 2012
- 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
- Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing
- ClinicalTrials.gov ID
- NCT01600209
- Acronym / sponsor ID
- Exact Sciences 2011-N
- Keywords
- Cancer, Colorectal Cancer, Neoplasm, Colorectal Neoplasm, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 674 participants (actual)
- Lead sponsor
- Exact Sciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 17 May 2012 (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 and specificity of a stool DNA test for detection of colorectal cancer and pre-cancer.
Detailed description
Patients who have recently undergone a colonoscopy that resulted with normal findings will be asked to submit a stool sample (s) (at least 30 days AFTER colonoscopy).
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Average risk patients | – | –Subjects will be men and women, 50-84 years of age, inclusive, each with a screening colonoscopy resulting in normal findings. |
Who may qualify
- Ages
- 50 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are at average risk of developing colorectal cancer at the time of their colonoscopy and the colonoscopy resulted in normal findings.
Key inclusion criteria (4 listed)
- Subject is male or female, 50-84 years of age, inclusive.
- Subject is at average risk for development of CRC and has undergone a screening colonoscopy with a normal result at least 30 days and no more than 120 days before providing a stool sample for the study. For the purposes of this study, a "normal" colonoscopy result is defined as no polyps of any size detected or removed (including benign, hyperplastic polyps).
- Subject is able to understand the study procedures, and is able to provide signed consent to participate in the study and authorizes release of relevant protected health information through signing a HIPAA consent.
- Subject is able and willing to provide stool samples at least 30 days and no more than 120 days after undergoing a colonoscopy that resulted in normal findings, according to the written instructions provided to them.
Key exclusion criteria (14 listed)
- Subject has any condition which, in the opinion of the investigator should preclude participation in the study.
- Subject had any findings on recent or any previous colonoscopy including benign, and/or hyperplastic polyps of any size. (Note: Tissue biopsies that result in no histopathology findings are acceptable.)
- Subject has a history or recent diagnosis of CRC or adenoma.
- Subject has a history of aerodigestive tract cancer.
- Subject has had a positive fecal occult blood test or FIT within the previous six (6) months.
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
Sensitivity and Specificity of the Exact CRC diagnostic screening test.
Time frame: 10 months
The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms.
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
13 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 Neoplasms and Digestive System Diseases, run by Exact Sciences Corporation at 13 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 4 inclusion and 14 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 13 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?
Sensitivity and Specificity of the Exact CRC diagnostic screening test. (time frame: 10 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 NCT01600209, 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.