Reflective Testing for Early Diagnosis of Pituitary Dysfunction

Pituitary Dysfunction Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02406417
• Other study ID #: RTFPI2015
• Status: Not yet recruiting
• Phase: N/A
• First received: March 2, 2015
• Last updated: March 30, 2015
• Start date: August 2015
• Est. completion date: April 2017

Study information

• Verified date: March 2015
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: April 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pituitary Diseases
• Pituitary Dysfunction

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Manal Elnenaei	Nova Scotia Health Authority

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients found to have biochemical evidence of possible pituitary dysfunction		One year	No
Secondary	Number of patients from primary outcome found to have true pituitary dysfunction		6- 12 months	No