Colorectal CancerEarly Phase 1SPR0012NCT01329718
Specimens for Septin 9 Performance
A Early Phase 1 study testing Blood Sample in people with Colorectal Cancer, run by Epigenomics, Inc.
Trial summary
Epigenomics has identified methylated gene regions that are specific for colorectal cancer (CRC). Through Epigenomics' marker discovery and validation process Septin 9 was identified as a particularly robust methylation marker for detection of CRC. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Blood Sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 562 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Dec 2012
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 years of age or older at the time of the blood draw
- Histologically confirmed or strong clinical suspicion of adenocarcinoma of the colon or rectum
- CRC defined as invasive adenocarcinoma
Who cannot join
- Previous personal history of colorectal cancer
- Any cancer specific treatment (e.g. polypectomy, chemotherapy, radiation, or surgery) prior to blood draw, including neoadjuvant treatment
- Known infection with HIV, HBV or HCV
- Subject concurrently receiving intravenous fluid at the time of the specimen collection
About this study
Official title: Specimen Collection Protocol for the Performance Evaluation of the Septin 9 Assay
Epigenomics has identified methylated gene regions that are specific for colorectal cancer (CRC). Through Epigenomics' marker discovery and validation process Septin 9 was identified as a particularly robust methylation marker for detection of CRC. Epigenomics is currently developing a blood based CRC screening test based on Septin 9 and is performing a large prospective clinical trial showing its clinical utility in a population at average risk for CRC. Parallel to this trial further activities are needed to evaluate, optimize, and develop pre-analytical and analytical workflows as well as molecular assays making possible the use of Septin 9 methylation in the clinical routine.
- Conditions
- Colorectal Cancer
- Being tested
- Blood Sample
- Keywords
- Stability of the Septin 9 biomarker, Epi Pro Colon Test, CRC
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SampleOther
Blood sample collection
| Study group | Role | What they receive |
|---|---|---|
| CRC Group | Experimental | Not described Receives: Other: Blood Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the Epi proColon test
The primary objective of the investigation is to determine the safety and effectiveness of the Epi proColon test in precision and reproducibility studies and varying conditions including interfering substances and co-morbidities associated with the testing population. The specimens collected as described in this protocol will be used in the experiments needed to achieve this objective. Validate the Stability of the Septin 9 Biomarker.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionDec 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 562 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epigenomics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329718
- Sponsor's protocol ID
- Epigenomics_SPR0012
- Acronym
- SPR0012
- Status last verified
- Aug 2014
- First submitted
- 4 Apr 2011
- Last updated
- 4 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
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
- Specimen Collection Protocol for the Performance Evaluation of the Septin 9 Assay
- ClinicalTrials.gov ID
- NCT01329718
- Acronym / sponsor ID
- SPR0012 / Epigenomics_SPR0012
- Conditions
- Colorectal Cancer
- Keywords
- Stability of the Septin 9 biomarker, Epi Pro Colon Test, CRC
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 562 participants (actual)
- Lead sponsor
- Epigenomics, IncIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 6 Apr 2011 (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.
Epigenomics has identified methylated gene regions that are specific for colorectal cancer (CRC). Through Epigenomics' marker discovery and validation process Septin 9 was identified as a particularly robust methylation marker for detection of CRC. Epigenomics is currently developing a blood based CRC screening test based on Septin 9 and is performing a large prospective clinical trial showing its clinical utility in a population at average risk for CRC. Parallel to this trial further activities are needed to evaluate, optimize, and develop pre-analytical and analytical workflows as well as molecular assays making possible the use of Septin 9 methylation in the clinical routine.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRC Group | Experimental | Other: Blood Sample |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 50 years of age or older at the time of the blood draw
- Histologically confirmed or strong clinical suspicion of adenocarcinoma of the colon or rectum
- CRC defined as invasive adenocarcinoma
Key exclusion criteria (4 listed)
- Previous personal history of colorectal cancer
- Any cancer specific treatment (e.g. polypectomy, chemotherapy, radiation, or surgery) prior to blood draw, including neoadjuvant treatment
- Known infection with HIV, HBV or HCV
- Subject concurrently receiving intravenous fluid at the time of the specimen collection
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 |
|---|---|---|
| Blood SampleBlood sample collection | Other | CRC Group |
Primary outcome
Effectiveness of the Epi proColon test
Time frame: 12 months
The primary objective of the investigation is to determine the safety and effectiveness of the Epi proColon test in precision and reproducibility studies and varying conditions including interfering substances and co-morbidities associated with the testing population. The specimens collected as described in this protocol will be used in the experiments needed to achieve this objective. Validate the Stability of the Septin 9 Biomarker.
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 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Blood Sample in people with Colorectal Cancer, run by Epigenomics, Inc.
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 4 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 4 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effectiveness of the Epi proColon test (time frame: 12 months). 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.