Reflective Testing for Early Diagnosis of Pituitary Dysfunction

NCT02406417 | Withdrawn DMC

• 1 other identifier: RTFPI2015
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pituitary Dysfunction

Outcome Measures

Primary Outcomes (1)

• Number of patients found to have biochemical evidence of possible pituitary dysfunction

  One year

Secondary Outcomes (1)

• Number of patients from primary outcome found to have true pituitary dysfunction

  6- 12 months

Study Arms (1)

Investigation for pituitary dysfunction

EXPERIMENTAL

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.; Device: Dynamic function tests and pituitary imaging

Interventions

Investigation for pituitary dysfunction by blood tests. DEVICE

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.

Investigation for pituitary dysfunction

Dynamic function tests and pituitary imaging DEVICE

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.

Investigation for pituitary dysfunction

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with known pituitary dysfunction or on medication that may affect pituitary function tests.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

MeSH Terms

Interventions

Physical Examination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: April 2, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 21, 2024

Record last verified: 2015-03