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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Acromegaly
• Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

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]