AcromegalySTOP-SSTNCT05149495
Somatostatin Analogues in the Treatment of Relapsing GH Pituitary Adenomas After Surgery
An observational study of Acromegaly, run by University Hospital, Strasbourg, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2021to 20 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject operated for a pituitary adenoma at the HUS between 01/01/2000 to 09/01/2021
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Service Médecine Interne, Endocrinologie et Nutrition - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Philippe BALTZINGER, MD, 33 3 88 12 75 82, philippe.baltzinger@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
Official title: 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.
- Conditions
- Acromegaly
- Keywords
- Acromegaly, Pituitary microadenoma, Pituitary macroadenoma, Somatostatin analogues, Hormonal control
- Medical subject headings
- Acromegaly
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of the clinical and biological evolution, after discontinuation of treatment with somatostatin analogues, of acromegalic patients with recurrence after surgery.
Measured: Files analysed retrospectively from January 01, 2000 to September 01, 2021 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Oct 2021
- Primary completionMar 2023 (estimated)
- Study completion20 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe BALTZINGER, MD, Principal investigator, Service Médecine Interne, Endocrinologie et Nutrition - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149495
- Sponsor's protocol ID
- 8409
- Acronym
- STOP-SST
- Status last verified
- Nov 2021
- First submitted
- 24 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance of Remission After Discontinuation of Somatostatin Analogues in the Treatment of Relapsing GH Pituitary Adenomas After Surgery
- ClinicalTrials.gov ID
- NCT05149495
- Acronym / sponsor ID
- STOP-SST / 8409
- Conditions
- Acromegaly
- Keywords
- Acromegaly, Pituitary microadenoma, Pituitary macroadenoma, Somatostatin analogues, Hormonal control
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- 20 Mar 2023 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject operated for a pituitary adenoma at the HUS between 01/01/2000 to 09/01/2021
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saïd CHAYER, PhD, HDR contact
Philippe BALTZINGER, MD principal investigator
Service Médecine Interne, Endocrinologie et Nutrition - Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe BALTZINGER, MD (33 3 88 12 75 82, philippe.baltzinger@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.