Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06297473 |
| Other study ID # |
SJ-1050 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2024 |
| Est. completion date |
August 1, 2028 |
Study information
| Verified date |
February 2024 |
| Source |
Zealand University Hospital |
| Contact |
Jesper Krogh, DMSc |
| Phone |
+4525535485 |
| Email |
jekrog[@]regionsjaelland.dk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The primary purpose of this study is to compare the safety of routine telephone assessment
versus in-person assessment during a two-year period for patients with non-functioning
pituitary adenomas. Secondly, to compare the quality of pituitary care in persons having
biochemical assessment once versus twice a year. Thirdly, to assess the rationale of repeated
assessment of pituitary function and imaging in patients with small pituitary tumors
(microadenomas).
Description:
This study intends to investigate the treatment quality, treatment safety, and patient
satisfaction of increased use of telephone/video clinics compared to physical attendance
during a three year period. Secondly, the study will assess the impact of reducing
biochemical assessment by 50 % and explore the possibility of reducing patients with
non-functioning pituitary tumors (NFPTs) affiliated to endocrine departments by 10 - 20 %.
Objective
1. The primary objective is to compare a phone/video follow-up versus standard follow-up in
adults with stable non-functioning pituitary tumors for the risk of admission for acute
adrenal crisis, poor visual outcome after pituitary surgery, or admission with hypo- or
hypernatremia caused by diabetes insipidus.
2. Main secondary objective is to compare yearly endocrine check-up versus endocrine
check-up every 6 months in adults with stable non-functioning pituitary tumors for
adequate control of hormonal replacement therapy.
3. To assess whether hormonal replacement therapy in patients followed by phone/video
consultation is non-inferior to patients followed with standard treatment.
4. Another secondary objective is to use the collected data to quantify the risk of
surgery/radiotherapy of pituitary tumor due to tumor growth or new endocrinopathies in
patients with micro-NFPTs.
Design This study is an investigator initiated pragmatic multicenter non-inferiority trial
with blinded outcome assessment.
Trial procedure Eligible patients will be approached at the yearly routine visit for
information of the trial. Patients fulfilling the inclusion criteria and none of exclusion
criteria will offered enrollment in the trial. Patients will be randomized to either at
standard treatment, planned yearly in-person visits for the next two years, or the
intervention which is planned yearly control by telephone or video contact for the next two
years. Following randomization there a no restrictions on patient care. Primary outcome will
be assessed from randomization to the last visit (2 years from randomization) by a blinded
adjudication committee.
A nurse or medical student will continuously monitor patient files for events. The study is
planned to run from April 1st 2024 to January 1st 2028.
Information from patient files Once patients have accepted participation in the trial,
information regarding previous disease history will be extracted. This include information on
co-morbidity, development of pituitary MRI findings, development in ophthalmological
findings, biochemistry, treatment related to pituitary failure, and treatment related to
pituitary adenoma in the form of surgery or radiotherapy.
Intervention Participants allocated to the intervention-group will receive their annual
endocrine review as a telephone or video contact for two years in a row. There will be no
differences in endocrine review, e.g. biochemical assessment or MRI. Patients or treating
physician can choose to make in-person assessment or follow-up if needed.
Comparator group Participants allocated to the comparator group will receive standard
treatment with yearly in-person assessment, e.g. biochemical and MRI.
