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

November 24, 2021 updated by: University Hospital, Strasbourg, France

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service Médecine Interne, Endocrinologie et Nutrition - Hôpitaux Universitaires de Strasbourg
        • Contact:
        • Principal Investigator:
          • Philippe Baltzinger, MD
        • Sub-Investigator:
          • Ninon STAHL, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subject operated for a pituitary adenoma at the HUS between 01/01/2000 to 09/01/2021

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2021

Primary Completion (ANTICIPATED)

March 1, 2023

Study Completion (ANTICIPATED)

March 20, 2023

Study Registration Dates

First Submitted

November 24, 2021

First Submitted That Met QC Criteria

November 24, 2021

First Posted (ACTUAL)

December 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 8, 2021

Last Update Submitted That Met QC Criteria

November 24, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8409

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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