Colorectal CancerNCT01574677
Assessment of Septin9 Biomarker for Detection of Colorectal Cancer in Patients With Positive Fecal Immunochemical Test
An observational study of Colorectal Cancer, run by Epigenomics, Inc at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 49 to 80 years
- Conditions the study is for
- Colorectal Cancer
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to not given
- 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 49 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kaiser Permanente Georgia
Atlanta, Georgia, 30300
Kaiser Permanente Northwest
Portland, Oregon, 97227
About this study
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.
Read more
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.
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, fecal immunochemical test, Septin 9, screening
- Medical subject headings
- Colorectal Neoplasms
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 |
|---|---|---|
| Screening FIT positive | Patients aged 49-80, with a positive screening FIT, who are referred to colonoscopy, and who meet inclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance characteristics of the Septin 9 biomarker among patients who have a positive FIT result
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.
Measured: 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.
Secondary outcomes (3)
Concordance and discordance (Kappa scores) between Septin 9 test results and colonoscopy findings associated with patient demographic factors.
Patient demographic factor such as age and gender will be assessed.
Measured: The timeframe for participation will generally be within 3 months of receiving a positive FIT result.
Concordance and discordance (Kappa scores) between Septin 9 test results and colonoscopy findings associated with co-morbid conditions.
Co-morbid conditions will include, for example, diabetes, congestive heart failure, etc.
Measured: The timeframe for participation will generally be within 3 months of receiving a positive FIT result.
Concordance and discordance (Kappa scores) between Septin 9 test results and colonoscopy findings associated with specific medication use practices.
Medications will include common medications in screening population (ie. blood thinners).
Measured: The timeframe for participation will generally be within 3 months of receiving a positive FIT result.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epigenomics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente, Emory University
- Responsible party
- Sponsor
- Investigators
- Gloria Coronado, PhD, Principal investigator, Kaiser Permanente, Center for Health Research NWAmanda Petrik, Study director, Kaiser Permanente Center for Health Research NW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574677
- Sponsor's protocol ID
- Septin 9 Colorectal Biomarker
- Status last verified
- Aug 2014
- First submitted
- 20 Mar 2012
- Last updated
- 4 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Septin9 Biomarker for Detection of Colorectal Cancer in Patients With Positive Fecal Immunochemical Test
- ClinicalTrials.gov ID
- NCT01574677
- Acronym / sponsor ID
- Septin 9 Colorectal Biomarker
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, fecal immunochemical test, Septin 9, screening
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Epigenomics, IncIndustry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente, Emory University
- Study start
- Jun 2012
- First posted
- 10 Apr 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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening FIT positive | – | –Patients aged 49-80, with a positive screening FIT, who are referred to colonoscopy, and who meet inclusion criteria. |
Who may qualify
- Ages
- 49 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
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
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.
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.
3 secondary outcomes
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.
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2014.
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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.
Gloria Coronado, PhD principal investigator
Kaiser Permanente, Center for Health Research NW
Amanda Petrik study director
Kaiser Permanente Center for Health Research NW
2 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 Cancer, run by Epigenomics, Inc at 2 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 7 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: withdrawn, as of the sponsor's last update on 4 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was withdrawn before enrolling participants, so there are no results.
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?
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.). 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 4 Aug 2014.