Acute AppendicitisAPPY1NCT01652170
The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis
An observational study of Acute Appendicitis, run by Venaxis, Inc. at 29 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 20 years
- Conditions the study is for
- Acute Appendicitis
- How many people
- 2,201 participants
- Where
- 29 sitesUnited States
- Study dates
- Jan 2013to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children, adolescents and young adults 2 to 20 years old.
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 11Show fewer
- 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.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
University of Michigan, Mott Children's Hospital
Ann Arbor, Michigan, 48109
Emory-Egleston (CHOA)
Atlanta, Georgia, 30322
Scottish Rite (CHOA)
Atlanta, Georgia, 30342
Dell Children's Medical Center
Austin, Texas, 78723
St. Joseph's Regional Health Center
Bryan, Texas, 77802
Medical University of South Carolina
Charleston, South Carolina, 29425
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Cleveland Clinic
Cleveland, Ohio, 44495
St. Joseph's Emergency Center
College Station, Texas, 77845
Nationwide Children's
Columbus, Ohio, 43205
Dallas Children's Hospital
Dallas, Texas, 75235
Spectrum Health System
Grand Rapids, Michigan, 49503
University of Florida, College of Medicine
Jacksonville, Florida, 32209
The Children's Mercy Hosptial
Kansas City, Missouri, 64108
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232
Newton-Wellesley Hospital
Newton, Massachusetts, 02462
Phoenix Children's Hosptial
Phoenix, Arizona, 85016
Children's Hospital of Pittsburg
Pittsburgh, Pennsylvania, 15224
OHSU
Portland, Oregon, 97239
Rhode Island Hospital - Hasbro
Providence, Rhode Island, 02903
UC Davis
Sacramento, California, 95817
Baystate Medical Center
Springfield, Massachusetts, 01199
All Children's Hospital
St. Petersburg, Florida, 33701
Staten Island University Hospital
Staten Island, New York, 10305
Children's National Medical Center
Washington D.C., District of Columbia, 20010
South Shore Hospital
Weymouth, Massachusetts, 02190
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27175
About this study
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
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.
- Conditions
- Acute Appendicitis
- Medical subject headings
- Appendicitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, Specificity, Negative and Positive Predictive Value
95% confidence intervals on Sensitivity and Specificity
Measured: Upon 3rd party review of data
Secondary outcomes (1)
CT utilization
CT utilization behaviors based on questions posed to the physicians about their current imaging intentions and those intentions were an APPY1 Test result available
Measured: Upon 3rd party review of data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startJan 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venaxis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dave Huckins, MD, Principal investigator, Newton-Wellesley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652170
- Sponsor's protocol ID
- CP12-001
- Acronym
- APPY1
- Status last verified
- Mar 2014
- First submitted
- 25 Jul 2012
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01652170
- Acronym / sponsor ID
- APPY1 / CP12-001
- Conditions
- Acute Appendicitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,201 participants (actual)
- Lead sponsor
- Venaxis, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 27 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children, adolescents and young adults 2 to 20 years old.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity, Specificity, Negative and Positive Predictive Value
Time frame: Upon 3rd party review of data
95% confidence intervals on Sensitivity and Specificity
1 secondary outcome
CT utilization
Time frame: Upon 3rd party review of data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
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PAINED: Project Addressing INequities in the Emergency Department
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dave Huckins, MD principal investigator
Newton-Wellesley Hospital
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Appendicitis, run by Venaxis, Inc. at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, Specificity, Negative and Positive Predictive Value (time frame: Upon 3rd party review of data). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2014.