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
  Purpose

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
Acute Appendicitis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Venaxis, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples Without DNA

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


Enrollment: 2201
Study Start Date: January 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   2 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652170

  Show 29 Study Locations
Sponsors and Collaborators
Venaxis, Inc.
Investigators
Principal Investigator: Dave Huckins, MD Newton-Wellesley Hospital
  More Information

No publications provided

Responsible Party: Venaxis, Inc.
ClinicalTrials.gov Identifier: NCT01652170     History of Changes
Other Study ID Numbers: CP12-001
Study First Received: July 25, 2012
Last Updated: March 20, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 24, 2014