STOP-SST: Somatostatin Analogues in the Treatment of Relapsing GH Pituitary Adenomas After Surgery

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05149495
Collaborator
(none)
100
1
17.6
5.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Maintenance of Remission After Discontinuation of Somatostatin Analogues in the Treatment of Relapsing GH Pituitary Adenomas After Surgery
    Actual Study Start Date :
    Oct 1, 2021
    Anticipated Primary Completion Date :
    Mar 1, 2023
    Anticipated Study Completion Date :
    Mar 20, 2023

    Outcome Measures

    Primary Outcome Measures

    1. 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]]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service Médecine Interne, Endocrinologie et Nutrition - Hôpitaux Universitaires de Strasbourg Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    • Principal Investigator: Philippe BALTZINGER, MD, Service Médecine Interne, Endocrinologie et Nutrition - Hôpitaux Universitaires de Strasbourg

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT05149495
    Other Study ID Numbers:
    • 8409
    First Posted:
    Dec 8, 2021
    Last Update Posted:
    Dec 8, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 8, 2021