search
Back to results

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
Manal Elnenaei
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pituitary Dysfunction

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 2, 2015
    Last Updated
    March 30, 2015
    Sponsor
    Manal Elnenaei
    Collaborators
    Nova Scotia Health Authority
    search

    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

    We'll reach out to this number within 24 hrs