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Assessment of Septin9 Biomarker for Detection of Colorectal Cancer in Patients With Positive Fecal Immunochemical Test

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborators:
Kaiser Permanente
Emory University
Information provided by (Responsible Party):
Epigenomics, Inc
ClinicalTrials.gov Identifier:
NCT01574677
First received: March 20, 2012
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

Colorectal cancer (CRC) is the second leading cause of cancer death in the United States and affects men and women almost equally. The United States Preventative Services Task Force (USPSTF) currently recommends screening with any of three options, which include fecal testing, flexible sigmoidoscopy, or colonoscopy.

Screening for CRC with fecal occult blood testing (using a guaiac-based test) done annually or biennially has been shown to decrease mortality 15-33% primarily through detection of early stage cancer. Guaiac fecal occult blood testing (gFOBT) has a known positive balance of benefit and risk in screening populations, is the least expensive, and is the preferred method of screening in 30-55% of patients. The fecal immunochemical test (FIT) offers significant improvements over the gFOBT, most notably that it is easier to use (requires fewer samples and no dietary or medication restrictions) and is more sensitive than the gFOBT with respect to detecting both CRC and precancerous adenomas. As a result of improved test performance and usability, in 2008 multiple professional societies endorsed the use of four types of FITs for colorectal cancer screening. Kaiser Permanente currently uses the OC-Micro FIT as the fecal screening test in all regions.

In recent years, intensive efforts have been undertaken to identify blood-based markers that may provide a promising alternative or supplement to fecal testing for non-invasive CRC screening. One method under development is to identify aberrantly methylated genes in cancer tissue through a blood test. Prior studies have explored those specific colorectal cancer genes that show the highest differences in methylation between the cancer and background genetic expression. Of these, methylation of the Septin 9 gene through a qPCR assay is relatively well studied.

The proposed study aims to evaluate whether the Septin 9 biomarker may be used to supplement the OC-Micro FIT for colorectal cancer screening in such a way as to safely reduce unneeded colonoscopies. The population of interest for this study—those with a positive screening OC-Micro fecal immunochemical test—has a CRC prevalence of approximately 5%. Knowing how well Septin 9 can identify those without cancer prior to colonoscopy is important largely because colonoscopy, even when done diagnostically (e.g., after a positive FIT result), can cause serious complications.


Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Septin9 Biomarker for Detection of Colorectal Cancer in Patients With Positive Fecal Immunochemical Test

Resource links provided by NLM:


Further study details as provided by Epigenomics, Inc:

Primary Outcome Measures:
  • Performance characteristics of the Septin 9 biomarker among patients who have a positive FIT result [ Time Frame: Participants are prospectively enrolled. Eligible participants will be asked to provide a blood sample at least 2 days prior to receiving a colonoscopy. The timeframe for participation will generally be within 3 months of receiving a positive FIT result. ] [ Designated as safety issue: No ]
    Sensitivity, specificity, positive predictive value, and negative predictive value of Septin 9 (relative to colonoscopy) for detecting CRC in a sample of individuals with a positive test result for single-sample OC-Micro FIT using various thresholds for Septin 9 positivity.


Secondary Outcome Measures:
  • Concordance and discordance (Kappa scores) between Septin 9 test results and colonoscopy findings associated with patient demographic factors. [ Time Frame: The timeframe for participation will generally be within 3 months of receiving a positive FIT result. ] [ Designated as safety issue: No ]
    Patient demographic factor such as age and gender will be assessed.

  • Concordance and discordance (Kappa scores) between Septin 9 test results and colonoscopy findings associated with co-morbid conditions. [ Time Frame: The timeframe for participation will generally be within 3 months of receiving a positive FIT result. ] [ Designated as safety issue: No ]
    Co-morbid conditions will include, for example, diabetes, congestive heart failure, etc.

  • Concordance and discordance (Kappa scores) between Septin 9 test results and colonoscopy findings associated with specific medication use practices. [ Time Frame: The timeframe for participation will generally be within 3 months of receiving a positive FIT result. ] [ Designated as safety issue: No ]
    Medications will include common medications in screening population (ie. blood thinners).


Enrollment: 0
Study Start Date: June 2012
Groups/Cohorts
Screening FIT positive
Patients aged 49-80, with a positive screening FIT, who are referred to colonoscopy, and who meet inclusion criteria.

  Eligibility

Ages Eligible for Study:   49 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Eligible subjects will be identified at Kaiser Permanente Northwest (KPNW) and Kaiser Permanente Georgia (KPGA). KPNW is a nonprofit group-model HMO with membership of about 485,000 in SW Washington and NW Oregon. KPNW includes 797 physician s and 395 allied clinicians (265 primary care providers). The member population base is similar to the local insured community in terms of age, gender, race, and ethnicity. About 19% of members are racial and ethnic minorities. Membership of KPGA has a racial and socioeconomic distribution similar to metropolitan Atlanta: ~ 50% Caucasian, 45% African American, 4% Hispanic, and 1% other races. 90 percent of the KPGA membership receives primary care at 12 medical offices owned and operated by KPGA and through contracts with 125 community practices.

Criteria

Inclusion Criteria:

  • Aged 49-80
  • Member of Kaiser Permanente Northwest or Southeast
  • English or Spanish speaking
  • Had a positive fecal screening (FIT) and has an active referral to colonoscopy

Exclusion Criteria:

  • Having a personal history of colon cancer
  • Having had a prior colonoscopy within 5 years
  • Currently under hospice care
  • Currently in a skilled nursing facility
  • Currently being treated for active cancer (any type)
  • Having ever had carcinoid tumor or full colectomy
  • Having indicated a preference at enrollment into Kaiser health plan to not participate in research
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574677

Locations
United States, Georgia
Kaiser Permanente Georgia
Atlanta, Georgia, United States, 30300
United States, Oregon
Kaiser Permanente Northwest
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Epigenomics, Inc
Kaiser Permanente
Emory University
Investigators
Principal Investigator: Gloria Coronado, PhD Kaiser Permanente, Center for Health Research NW
Study Director: Amanda Petrik Kaiser Permanente Center for Health Research NW
  More Information

No publications provided

Responsible Party: Epigenomics, Inc
ClinicalTrials.gov Identifier: NCT01574677     History of Changes
Other Study ID Numbers: Septin 9 Colorectal Biomarker
Study First Received: March 20, 2012
Last Updated: August 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Epigenomics, Inc:
Colorectal cancer
fecal immunochemical test
Septin 9
screening

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on November 19, 2014