The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis
APPY1
1 other identifier
observational
2,201
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2013
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2012
CompletedFirst Posted
Study publicly available on registry
July 27, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedMarch 24, 2014
March 1, 2014
1.1 years
July 25, 2012
March 20, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity, Specificity, Negative and Positive Predictive Value
95% confidence intervals on Sensitivity and Specificity
Upon 3rd party review of data
Secondary Outcomes (1)
CT utilization
Upon 3rd party review of data
Eligibility Criteria
Children, adolescents and young adults 2 to 20 years old.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Venaxis, Inc.lead
Study Sites (29)
Phoenix Children's Hosptial
Phoenix, Arizona, 85016, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
UC Davis
Sacramento, California, 95817, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
University of Florida, College of Medicine
Jacksonville, Florida, 32209, United States
All Children's Hospital
St. Petersburg, Florida, 33701, United States
Emory-Egleston (CHOA)
Atlanta, Georgia, 30322, United States
Scottish Rite (CHOA)
Atlanta, Georgia, 30342, United States
Newton-Wellesley Hospital
Newton, Massachusetts, 02462, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
South Shore Hospital
Weymouth, Massachusetts, 02190, United States
University of Michigan, Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Spectrum Health System
Grand Rapids, Michigan, 49503, United States
The Children's Mercy Hosptial
Kansas City, Missouri, 64108, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766, United States
Staten Island University Hospital
Staten Island, New York, 10305, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27175, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
Cleveland Clinic
Cleveland, Ohio, 44495, United States
Nationwide Children's
Columbus, Ohio, 43205, United States
OHSU
Portland, Oregon, 97239, United States
Children's Hospital of Pittsburg
Pittsburgh, Pennsylvania, 15224, United States
Rhode Island Hospital - Hasbro
Providence, Rhode Island, 02903, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232, United States
Dell Children's Medical Center
Austin, Texas, 78723, United States
St. Joseph's Regional Health Center
Bryan, Texas, 77802, United States
St. Joseph's Emergency Center
College Station, Texas, 77845, United States
Dallas Children's Hospital
Dallas, Texas, 75235, United States
Biospecimen
Surplus plasma samples will be retrieved by the Sponsor for future development of protein biomarkers.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dave Huckins, MD
Newton-Wellesley Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2012
First Posted
July 27, 2012
Study Start
January 1, 2013
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
March 24, 2014
Record last verified: 2014-03