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NCT05149495 Clinical Trial

Somatostatin Analogues in the Treatment of Relapsing GH Pituitary Adenomas After Surgery

Acromegaly Clinical Trial

— STOP-SST  

Official title:
Maintenance of Remission After Discontinuation of Somatostatin Analogues in the Treatment of Relapsing GH Pituitary Adenomas After Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05149495
Other study ID # 8409
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date March 20, 2023

Study information
Verified date November 2021
Source University Hospital, Strasbourg, France
Contact Philippe BALTZINGER, MD
Phone 33 3 88 12 75 82
Email philippe.baltzinger@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

At present there are no recommendations regarding the possibility of discontinuing treatment in cases of recurrent acromegaly with good hormonal control. Discontinuation of treatment is therefore most often decided by the practitioner, on the basis of his experience and knowledge of the patient, the long-term course with somatostatin analogues being very little described. Thus, although hormonal control is achieved in a majority of cases under medical treatment, we do not know if it is possible to stop treatment and in this case how the pathology evolves. It would appear that approximately 40% of patients defined as very good responders to somatostatin analogues may gradually space their injections.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date March 20, 2023
Est. primary completion date March 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Major subject (=18 years old) - Having been seen at least once in consultation in the Internal Medicine, Endocrinology and Nutrition department of Hautepierre Hospital - Subject operated for a pituitary adenoma at the HUS between 01/01/2000 to 09/01/2021 - In whom biological confirmation of recurrence has been demonstrated - Patient not having expressed his opposition, after information, to the reuse of his data for scientific research purposes. Exclusion criteria: - Subject having expressed opposition to participating in the study - Treatment pre and / or post surgery by radiotherapy - No recurrence - No treatment with a somatostatin analogue for recurrence - Subject under guardianship, curatorship or safeguard of justice

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Service Médecine Interne, Endocrinologie et Nutrition - Hôpitaux Universitaires de Strasbourg Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Study of the clinical and biological evolution, after discontinuation of treatment with somatostatin analogues, of acromegalic patients with recurrence after surgery. Files analysed retrospectively from January 01, 2000 to September 01, 2021 will be examined]
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