Clinical trial NCT01652170: The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Appendicitis
Lead sponsor: Venaxis, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-27
Enrollment: 2201
Sex: ALL
Minimum age (years): 2
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children, adolescents and young adults 2 to 20 years old.

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.


Eligibility 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.

Primary outcomes:
measure: Sensitivity, Specificity, Negative and Positive Predictive Value
timeFrame: Upon 3rd party review of data
Secondary outcomes:
measure: CT utilization
timeFrame: Upon 3rd party review of data
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hosptial
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Sacramento
country: United States
facility: UC Davis
state: California
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Jacksonville
country: United States
facility: University of Florida, College of Medicine
state: Florida
city: St. Petersburg
country: United States
facility: All Children's Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory-Egleston (CHOA)
state: Georgia
city: Atlanta
country: United States
facility: Scottish Rite (CHOA)
state: Georgia
city: Newton
country: United States
facility: Newton-Wellesley Hospital
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Weymouth
country: United States
facility: South Shore Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan, Mott Children's Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health System
state: Michigan
city: Kansas City
country: United States
facility: The Children's Mercy Hosptial
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's
state: Ohio
city: Portland
country: United States
facility: OHSU
state: Oregon
city: Pittsburg
country: United States
facility: Children's Hospital of Pittsburg
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital - Hasbro
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Children's Hospital
state: Tennessee
city: Austin
country: United States
facility: Dell Children's Medical Center
state: Texas
city: Bryan
country: United States
facility: St. Joseph's Regional Health Center
state: Texas
city: College Station
country: United States
facility: St. Joseph's Emergency Center
state: Texas
city: Dallas
country: United States
facility: Dallas Children's Hospital
state: Texas
Study officials:
affiliation: Newton-Wellesley Hospital
name: Dave Huckins, MD
role: PRINCIPAL_INVESTIGATOR
References: