NCT05149495

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2023

Completed
Last Updated

December 8, 2021

Status Verified

November 1, 2021

Enrollment Period

1.4 years

First QC Date

November 24, 2021

Last Update Submit

November 24, 2021

Conditions

Keywords

AcromegalyPituitary microadenomaPituitary macroadenomaSomatostatin analoguesHormonal control

Outcome Measures

Primary Outcomes (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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Philippe BALTZINGER, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saïd CHAYER, PhD, HDR

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2021

First Posted

December 8, 2021

Study Start

October 1, 2021

Primary Completion

March 1, 2023

Study Completion

March 20, 2023

Last Updated

December 8, 2021

Record last verified: 2021-11

Locations