Reflective Testing for Early Diagnosis of Pituitary Dysfunction

March 30, 2015 updated by: Manal Elnenaei

The Use of Reflex Strategies and Reflective Testing in the Clinical Chemistry Laboratory for Early Detection of Pituitary Dysfunction in Patients From Primary Care.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigation for pituitary dysfunction
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.
Device: Investigation for pituitary dysfunction by blood tests.
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.
Device: Dynamic function tests and pituitary imaging
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients found to have biochemical evidence of possible pituitary dysfunction
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients from primary outcome found to have true pituitary dysfunction
Time Frame: 6- 12 months
6- 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manal Elnenaei

Collaborators

Nova Scotia Health Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

March 2, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimate)

April 2, 2015

Study Record Updates

Last Update Posted (Estimate)

April 2, 2015

Last Update Submitted That Met QC Criteria

March 30, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTFPI2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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