Reflective Testing for Early Diagnosis of Pituitary Dysfunction
Primary Purpose
Pituitary Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Investigation for pituitary dysfunction by blood tests.
Dynamic function tests and pituitary imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Pituitary Dysfunction
Eligibility Criteria
Inclusion Criteria:
- Patients from Primary Care found to have one or more abnormal pituitary function test picked up by the laboratory information system in the Clinical Chemistry laboratory.
Exclusion Criteria:
- Patients with known pituitary dysfunction or on medication that may affect pituitary function tests.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Investigation for pituitary dysfunction
Arm Description
Further investigation for pituitary dysfunction by blood tests, dynamic function tests and pituitary imaging e.g. CT Scan with contrast. Patients identified as being at high risk of having pituitary dysfunction based on preliminary blood tests will have further tests added. If these results point to a likely pituitary dysfunction, the patient will be referred to the Endocrine team for further investigations including dynamic function tests and/or imaging.
Outcomes
Primary Outcome Measures
Number of patients found to have biochemical evidence of possible pituitary dysfunction
Secondary Outcome Measures
Number of patients from primary outcome found to have true pituitary dysfunction
Full Information
NCT ID
NCT02406417
First Posted
March 2, 2015
Last Updated
March 30, 2015
Sponsor
Manal Elnenaei
Collaborators
Nova Scotia Health Authority
1. Study Identification
Unique Protocol Identification Number
NCT02406417
Brief Title
Reflective Testing for Early Diagnosis of Pituitary Dysfunction
Official Title
The Use of Reflex Strategies and Reflective Testing in the Clinical Chemistry Laboratory for Early Detection of Pituitary Dysfunction in Patients From Primary Care.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
April 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Manal Elnenaei
Collaborators
Nova Scotia Health Authority
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Early detection and management of pituitary dysfunction reduces the morbidity that ensues as a consequence of missed or delayed diagnosis of this condition, and which may result in life-threatening events and increased mortality.
The investigators study will explore the use of reflex strategies within the laboratory in capturing suspicious pituitary function test results from Primary Care patients and following these up with appropriate reflective testing. Subsequently patients identified from these results to have a possible underlying piuitary dysfunction will have an alert sent to their family physician prompting referral to the Endocrine team for further investigation and management.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Dysfunction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Investigation for pituitary dysfunction
Arm Type
Experimental
Arm Description
Further investigation for pituitary dysfunction by blood tests, dynamic function tests and pituitary imaging e.g. CT Scan with contrast. Patients identified as being at high risk of having pituitary dysfunction based on preliminary blood tests will have further tests added. If these results point to a likely pituitary dysfunction, the patient will be referred to the Endocrine team for further investigations including dynamic function tests and/or imaging.
Intervention Type
Device
Intervention Name(s)
Investigation for pituitary dysfunction by blood tests.
Intervention Description
Blood tests for pituitary function (one or more of the following tests: cortisol, LH, FSH, TSH, FT4, testosterone, prolactin) will be added to samples from patients identified as being at high risk from their initial blood results.
Intervention Type
Device
Intervention Name(s)
Dynamic function tests and pituitary imaging
Intervention Description
Patients identified as being highly likely to have a pituitary dysfunction from the results of the blood tests for pituitary function added, will be referred to the Endocrine team for further tests in the form of dynamic function tests and pituitary imaging.
Primary Outcome Measure Information:
Title
Number of patients found to have biochemical evidence of possible pituitary dysfunction
Time Frame
One year
Secondary Outcome Measure Information:
Title
Number of patients from primary outcome found to have true pituitary dysfunction
Time Frame
6- 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients from Primary Care found to have one or more abnormal pituitary function test picked up by the laboratory information system in the Clinical Chemistry laboratory.
Exclusion Criteria:
Patients with known pituitary dysfunction or on medication that may affect pituitary function tests.
12. IPD Sharing Statement
Learn more about this trial
Reflective Testing for Early Diagnosis of Pituitary Dysfunction
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