Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies
This study is currently recruiting participants.
Verified March 2013 by Exact Sciences Corporation
Sponsor:
Exact Sciences Corporation
Information provided by (Responsible Party):
Exact Sciences Corporation
ClinicalTrials.gov Identifier:
NCT01260168
First received: December 6, 2010
Last updated: March 15, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Colorectal Neoplasms Digestive System Diseases Colonic Diseases Colorectal Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only |
| Official Title: | Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies |
Resource links provided by NLM:
MedlinePlus related topics:
Bowel Movement
Cancer
Colonic Diseases
Colorectal Cancer
Digestive Diseases
U.S. FDA Resources
Further study details as provided by Exact Sciences Corporation:
Primary Outcome Measures:
- The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- To collect samples from patients diagnosed with colorectal cancers. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
Residual specimens and histopathology tissue slides or blocks will be stored for up to 10 years in the Sponsor's on-site bio-repository or similar commercial bio-repository contracted by the Sponsor.
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 40 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients who have had colorectal cancer or pre-malignancy confirmed by colonoscopic biopsy-based diagnosis.
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260168
Contacts
| Contact: Nada Mlinarevich, MPH, RN | (608) 284-5747 | nmlinarevich@exactsciences.com |
Locations
| United States, Alabama | |
| Achieve Clinical Research, LLC | Terminated |
| Birmingham, Alabama, United States, 35216 | |
| Clinical Research Associates | Terminated |
| Huntsville, Alabama, United States, 35801 | |
| United States, Georgia | |
| Atlanta Gastroenterology | Terminated |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| Stroger Cook County | Terminated |
| Chicago, Illinois, United States, 60612 | |
| Rush University Gastroenterologists | Terminated |
| Chicago, Illinois, United States, 60612 | |
| Jesse Brown VA | Terminated |
| Chicago, Illinois, United States, 60612 | |
| University of Illinois at Chicago | Terminated |
| Chicago, Illinois, United States, 60612 | |
| Rockford Gastroenterology Associates, Ltd | Terminated |
| Rockford, Illinois, United States, 61107 | |
| United States, Louisiana | |
| Gastroenterology Associates | Terminated |
| Baton Rouge, Louisiana, United States, 70809 | |
| United States, Maryland | |
| Chevy Chase Clinical Research | Recruiting |
| Chevy Chase, Maryland, United States, 20815 | |
| Contact: Marissa Mallek 301-652-5520 marissa.mallek@capitaldigestivecare.com | |
| Principal Investigator: Robert Hardi, MD | |
| United States, Massachusetts | |
| Commonwealth Clinical Studies | Recruiting |
| Brockton, Massachusetts, United States, 02302 | |
| Contact: Beth Oleson 508-588-9900 boleson@gisdoc.com | |
| Principal Investigator: Jerry Stern, MD | |
| United States, New York | |
| Long Island Gastrointestinal Group | Recruiting |
| Great Neck, New York, United States, 11023 | |
| Contact: Christine Raiser-Vignola, RN 516-482-5976 christineraiser@aol.com | |
| Principal Investigator: Michael Goldstein, MD | |
| Mount Sinai School of Medicine | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Lina Jandorf 212-659-5506 lina.jandorf@mssm.edu | |
| Principal Investigator: Steven Itzkowitz, MD | |
| United States, North Carolina | |
| Asheville Gastroenterology | Terminated |
| Asheville, North Carolina, United States, 28801 | |
| Southern Gastroenterology Associates | Terminated |
| New Bern, North Carolina, United States, 28562 | |
| United States, Oregon | |
| Northwest Gastroenterology Clinic, LLC | Terminated |
| Portland, Oregon, United States, 97208 | |
| United States, Tennessee | |
| Gastro One | Terminated |
| Germantown, Tennessee, United States, 38138 | |
| United States, Texas | |
| Digestive Health Specialists | Recruiting |
| Tyler, Texas, United States, 75701 | |
| Contact: Susan Mushinki 903-595-5101 susanm@dhstyler.com | |
| Principal Investigator: Richard Seidel, MD | |
| United States, Utah | |
| University of Utah | Terminated |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Virginia | |
| Digestive and Liver Disease Specialists | Terminated |
| Norfolk, Virginia, United States, 23502 | |
| Canada, Alberta | |
| University of Calgary | Recruiting |
| Calgary, Alberta, Canada, T2N 4Z6 | |
| Contact: Susanna Town 403-592-5052 susanna.town@ucalgary.ca | |
| Principal Investigator: Robert Hilsden, MD | |
Sponsors and Collaborators
Exact Sciences Corporation
Investigators
| Study Chair: | Graham Lidgard, PhD | Chief Scientific Officer |
More Information
No publications provided
| Responsible Party: | Exact Sciences Corporation |
| ClinicalTrials.gov Identifier: | NCT01260168 History of Changes |
| Other Study ID Numbers: | Exact Sciences 2010-A |
| Study First Received: | December 6, 2010 |
| Last Updated: | March 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Exact Sciences Corporation:
|
Digestive System Diseases Gastrointestinal Diseases Cancer Colorectal Cancer Neoplasm Colorectal Neoplasm Intestinal Neoplasms |
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Colonic Diseases Intestinal Diseases Rectal Diseases |
Additional relevant MeSH terms:
|
Digestive System Diseases Gastrointestinal Diseases Neoplasms Colonic Diseases Colorectal Neoplasms Intestinal Diseases |
Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Rectal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013