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

NCT ID: NCT05149495

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acromegaly

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Acromegaly Pituitary microadenoma Pituitary macroadenoma Somatostatin analogues Hormonal control

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Philippe BALTZINGER, MD

Role: PRINCIPAL_INVESTIGATOR

Service Médecine Interne, Endocrinologie et Nutrition - Hôpitaux Universitaires de Strasbourg

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Service Médecine Interne, Endocrinologie et Nutrition - Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Philippe BALTZINGER, MD

Role: CONTACT

Phone: 33 3 88 12 75 82

Email: [email protected]

Saïd CHAYER, PhD, HDR

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Philippe BALTZINGER, MD

Role: primary

Saïd CHAYER, PhD, HDR

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

8409

Identifier Type: -

Identifier Source: org_study_id