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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Venaxis, Inc.
ClinicalTrials.gov Identifier:
NCT01652170
First received: July 25, 2012
Last updated: March 20, 2014
Last verified: March 2014

July 25, 2012
March 20, 2014
January 2013
February 2014   (final data collection date for primary outcome measure)
Sensitivity, Specificity, Negative and Positive Predictive Value [ Time Frame: Upon 3rd party review of data ] [ Designated as safety issue: No ]
95% confidence intervals on Sensitivity and Specificity
Not Provided
Complete list of historical versions of study NCT01652170 on ClinicalTrials.gov Archive Site
CT utilization [ Time Frame: Upon 3rd party review of data ] [ Designated as safety issue: No ]
CT utilization behaviors based on questions posed to the physicians about their current imaging intentions and those intentions were an APPY1 Test result available
Not Provided
Not Provided
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The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis
The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis in Children, Adolescents, and Young Adults Presenting to the Emergency Department

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Surplus plasma samples will be retrieved by the Sponsor for future development of protein biomarkers.

Non-Probability Sample

Children, adolescents and young adults 2 to 20 years old.

Acute Appendicitis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2201
February 2014
February 2014   (final data collection date for primary outcome measure)

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.
Both
2 Years to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01652170
CP12-001
Yes
Venaxis, Inc.
Venaxis, Inc.
Not Provided
Principal Investigator: Dave Huckins, MD Newton-Wellesley Hospital
Venaxis, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP