Colorectal Cancer ScreeningNCT01052922
Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement
A study testing 3 sample g-SENSA, 2 sample InSure and 1 sample OC-Micron in people with Colorectal Cancer Screening, run by Kaiser Permanente at 1 site in United States.
Trial summary
Ancillary Aim #1 We will evaluate intervention effects by comparing binary outcomes for screening (yes/no) in the primary SOS study. In this aim, we propose to calculate actual screening rates by use of time-to-event analyses (also known as survival analysis). Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- 3 sample g-SENSA, 2 sample InSure and 1 sample OC-Micron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,260 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Dec 2011
- Phase
- Interventional
- 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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Not up to date on CRCS
- Continuously enrolled in GHC for 24 months
- Expected to continue to be enrolled at GHC for 24 months
Who cannot join
- Known high risk for CRC
- History of CRC
- History of inflammatory bowel disease
- Current anticoagulation therapy
- Organ failure
- Serious illness
Show all 9Show fewer
- Debilitating disease
- Dementia
- Nursing home resident.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Washinton Health Research Institute
Seattle, Washington, 98101
About this study
Ancillary Aim #1 We will evaluate intervention effects by comparing binary outcomes for screening (yes/no) in the primary SOS study. In this aim, we propose to calculate actual screening rates by use of time-to-event analyses (also known as survival analysis). The outcome variable of interest is the first time since randomization to have CRCS, either based on FOBT, FS, or CS. Knowing screening rates will not only enable us to make comparisons between groups, but also over time.
Ancillary Aims #2 and #3 We will recruit additional participants for two ancillary study aims. First, we will enroll patients age 50-74 years using the same criteria as for the primary SOS study, which includes neither history of colorectal cancer nor evidence of life-limiting disease. Participants who return the questionnaire, consent and considered eligible will be randomized to receive one of three different at-home fecal test kits. The kits will be returned to the GH centralized laboratory, and participants will be informed about lab results using standard GH pathways. Participants who have a test-positive will receive a series of two follow-up surveys (first at 1-2 weeks post result and second at 4-months post result). A comparison group of test-negative results will be matched based on selected criteria, and this group will also receive the follow-up surveys. Participants at both time intervals who do not return the survey via mail will be called and if available, administered the questionnaire via phone.
- Conditions
- Colorectal Cancer Screening
- Being tested
- 3 sample g-SENSA, 2 sample InSure, 1 sample OC-Micron
- Keywords
- Colorectal Neoplasms, Mass Screening, Population Surveillance, Randomized controlled trial, Occult Blood, Colonoscopy, Sigmoidoscopy, Health Behavior
- Medical subject headings
- Colorectal Neoplasms, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 sample g-SENSAOther
Participants will be mailed to a 3 sample g-SENSA FOBT kit to complete at home and mail back to the lab for screening.
2 sample InSureOther
Participants will be mailed to a 2 sample InSure FOBT kit to complete at home and mail back to the lab for screening.
1 sample OC-MicronOther
Participants will be mailed to a 1 sample OC-MICRON FOBT kit to complete at home and mail back to the lab for screening.
| Study group | Role | What they receive |
|---|---|---|
| 2 sample InSure | Active comparator | Not described Receives: Other: 2 sample InSure |
| 1 sample OC-Micron | Active comparator | Not described Receives: Other: 1 sample OC-Micron |
| 3 sample g-SENSA | Active comparator | Not described Receives: Other: 3 sample g-SENSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to FOBT test kit
Measured: 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startAug 2009
- Primary completionDec 2011
- Study completionDec 2011
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 Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, University of Washington
- Responsible party
- Sponsor
- Investigators
- Beverly B Green, MD,MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052922
- Sponsor's protocol ID
- 3R01CA121125-03S1
- Status last verified
- Oct 2017
- First submitted
- 19 Jan 2010
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Chubak J, Bogart A, Fuller S, Laing SS, Green BB. Uptake and positive predictive value of fecal occult blood tests: A randomized controlled trial. Prev Med. 2013 Nov;57(5):671-8. doi: 10.1016/j.ypmed.2013.08.032. Epub 2013 Sep 9.
PubMed 24029556
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement
- ClinicalTrials.gov ID
- NCT01052922
- Acronym / sponsor ID
- 3R01CA121125-03S1
- Conditions
- Colorectal Cancer Screening
- Keywords
- Colorectal Neoplasms, Mass Screening, Population Surveillance, Randomized controlled trial, Occult Blood, Colonoscopy, Sigmoidoscopy, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,260 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, University of Washington
- Study start
- Aug 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Jan 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.
Ancillary Aim #1 We will evaluate intervention effects by comparing binary outcomes for screening (yes/no) in the primary SOS study. In this aim, we propose to calculate actual screening rates by use of time-to-event analyses (also known as survival analysis). The outcome variable of interest is the first time since randomization to have CRCS, either based on FOBT, FS, or CS. Knowing screening rates will not only enable us to make comparisons between groups, but also over time.
Ancillary Aims #2 and #3 We will recruit additional participants for two ancillary study aims. First, we will enroll patients age 50-74 years using the same criteria as for the primary SOS study, which includes neither history of colorectal cancer nor evidence of life-limiting disease. Participants who return the questionnaire, consent and considered eligible will be randomized to receive one of three different at-home fecal test kits. The kits will be returned to the GH centralized laboratory, and participants will be informed about lab results using standard GH pathways. Participants who have a test-positive will receive a series of two follow-up surveys (first at 1-2 weeks post result and second at 4-months post result). A comparison group of test-negative results will be matched based on selected criteria, and this group will also receive the follow-up surveys. Participants at both time intervals who do not return the survey via mail will be called and if available, administered the questionnaire via phone.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 sample InSure | Active comparator | Other: 2 sample InSure |
| 1 sample OC-Micron | Active comparator | Other: 1 sample OC-Micron |
| 3 sample g-SENSA | Active comparator | Other: 3 sample g-SENSA |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Not up to date on CRCS
- Continuously enrolled in GHC for 24 months
- Expected to continue to be enrolled at GHC for 24 months
Key exclusion criteria (9 listed)
- Known high risk for CRC
- History of CRC
- History of inflammatory bowel disease
- Current anticoagulation therapy
- Organ failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 sample g-SENSAParticipants will be mailed to a 3 sample g-SENSA FOBT kit to complete at home and mail back to the lab for screening. | Other | 3 sample g-SENSA |
| 2 sample InSureParticipants will be mailed to a 2 sample InSure FOBT kit to complete at home and mail back to the lab for screening. | Other | 2 sample InSure |
| 1 sample OC-MicronParticipants will be mailed to a 1 sample OC-MICRON FOBT kit to complete at home and mail back to the lab for screening. | Other | 1 sample OC-Micron |
Primary outcome
Adherence to FOBT test kit
Time frame: 1-2 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 Oct 2017.
- Derived from this study: PubMed 24029556Chubak J, Bogart A, Fuller S, Laing SS, Green BB. Uptake and positive predictive value of fecal occult blood tests: A randomized controlled trial. Prev Med. 2013 Nov;57(5):671-8. doi: 10.1016/j.ypmed.2013.08.032. Epub 2013 Sep 9.
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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.
Beverly B Green, MD,MPH principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 sample g-SENSA, 2 sample InSure and 1 sample OC-Micron in people with Colorectal Cancer Screening, run by Kaiser Permanente at 1 site 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 3 inclusion and 9 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 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Adherence to FOBT test kit (time frame: 1-2 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 NCT01052922, 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 Oct 2017.