The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis (APPY1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01652170
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : March 24, 2014
Information provided by (Responsible Party):
Venaxis, Inc.

Brief Summary:
This study will consist of a brief interaction with the subject or parent or guardian to obtain consent, collect a blood sample, medical history, and physical examination of those who meet the inclusion criteria. The blood sample will be tested for the WBC value, as well as processed into plasma in order to compute the APPY1 Test result, which is based on a combination of the WBC value and the plasma MRP 8/14 and CRP concentrations received from the APPY1 Test cassette. There will be a 2-week (14 days +/- 3) follow-up telephone call for those subjects that were discharged from the ED without an appendectomy or diagnosis of acute appendicitis. Use of the APPY1 Test to help identify low risk patients could significantly reduce the use of CT scans in diagnosis of AA, thereby reducing the exposure to ionizing radiation in children, adolescents, and young adults.

Condition or disease
Acute Appendicitis

Study Type : Observational
Actual Enrollment : 2201 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis in Children, Adolescents, and Young Adults Presenting to the Emergency Department
Study Start Date : January 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Primary Outcome Measures :
  1. Sensitivity, Specificity, Negative and Positive Predictive Value [ Time Frame: Upon 3rd party review of data ]
    95% confidence intervals on Sensitivity and Specificity

Secondary Outcome Measures :
  1. CT utilization [ Time Frame: Upon 3rd party review of data ]
    CT utilization behaviors based on questions posed to the physicians about their current imaging intentions and those intentions were an APPY1 Test result available

Biospecimen Retention:   Samples Without DNA
Surplus plasma samples will be retrieved by the Sponsor for future development of protein biomarkers.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children, adolescents and young adults 2 to 20 years old.

Inclusion Criteria:

  • 2 to 20 years old (up until the 21st birthday),
  • Right lower quadrant or poorly localized abdominal pain, or tenderness that includes the right lower quadrant, and/or other features including, but not limited to, nausea, vomiting, and/or anorexia, requiring acute appendicitis to be added to the differential,
  • Onset of abdominal pain within 72 hours or less,
  • Patients of either gender may participate and,
  • Patient or accompanying parent or guardian is able to provide informed consent.

Exclusion Criteria:

  • History includes prior appendectomy,
  • Subjects whose presentation history and physical examination place them at such high risk of acute appendicitis that it would be clinically reasonable to proceed with exploratory laparotomy and/or appendectomy without advanced imaging,
  • Treatment with any immunosuppressive medication or chemotherapeutic agents within 28 days, or systemic steroids (oral or intravenous) within 14 days,
  • History of end-stage, metastatic cancer or an active immune disorder,
  • History includes abdominal trauma or invasive abdominal procedures/surgery within the previous two weeks,
  • Patients who have received diagnostic imaging (CT, MRI, or US) for abdominal pain in the previous two weeks,
  • Patients with report of abdominal pain greater than 72 hours,
  • History of active bleeding disorder, which may complicate phlebotomy or placement of peripheral IV catheter,
  • Participation in a research study within the previous 30 days,
  • Prisoners of an adult or juvenile detention center, and
  • Subject, parent or guardian unable to provide informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01652170

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Sponsors and Collaborators
Venaxis, Inc.
Principal Investigator: Dave Huckins, MD Newton-Wellesley Hospital

Responsible Party: Venaxis, Inc. Identifier: NCT01652170     History of Changes
Other Study ID Numbers: CP12-001
First Posted: July 27, 2012    Key Record Dates
Last Update Posted: March 24, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Acute Disease
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes