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Specimens for Septin 9 Performance (SPR0012)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Blood Sample
Sponsored by
Epigenomics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Stability of the Septin 9 biomarker, Epi Pro Colon Test, CRC

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    CRC Group

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 4, 2011
    Last Updated
    August 1, 2014
    Sponsor
    Epigenomics, Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01329718
    Brief Title
    Specimens for Septin 9 Performance
    Acronym
    SPR0012
    Official Title
    Specimen Collection Protocol for the Performance Evaluation of the Septin 9 Assay
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2011 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    December 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Epigenomics, Inc

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer
    Keywords
    Stability of the Septin 9 biomarker, Epi Pro Colon Test, CRC

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Enrollment
    562 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CRC Group
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Blood Sample
    Intervention Description
    Blood sample collection
    Primary Outcome Measure Information:
    Title
    Effectiveness of the Epi proColon test
    Description
    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.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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

    12. IPD Sharing Statement

    Learn more about this trial

    Specimens for Septin 9 Performance

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