Status:
COMPLETED
Late Effects of Radiosurgery on Acromegaly Study
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Acromegaly
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Transsphenoidal surgery is the first-line treatment of acromegaly. Adjunctive radiotherapy can be necessary when surgery is ineffective to avoid a prolonged medical treatment. Several studies reported...
Eligibility Criteria
Inclusion
- Subject, man or woman, whose age is greater than or equal to 18 years;
- Subject has a combination of defined values plus Insulin Like Growth Factor-1 and no braking growth hormone (\<1.2 milli-International unit/L) during an oral glucose tolerance acromegaly.
- Exposed: Subject with a surgically treated in remission with or without drug treatment somatostatinergic, acromegaly who received treatment with Gamma Knife radiosurgery within not less than 10 years and less than or equal to 20 years.
- Not exposed: Subject with a surgically treated acromegaly controlled by treatment somatostatinergic, not having received Gamma Knife radiosurgery.
- Subjects with thyroid under standardized assessment Levothyrox® inclusion in case of deficit associated thyroid stimulating;
- Topic supported in a project partner services;
- Subjects who have signed a written informed consent and agreeing to abide by the instructions of the protocol.
Exclusion
- Minor or over the age of 75 years subject,
- Subjects with acromegaly resistant to somatostatinergic, or that required power is pegvisomant or cabergoline
- Subjects who received two pituitary neurosurgical treatment or treatment with conventional radiotherapy or radiosurgery treatments 2
- Pregnant or lactating woman,
- Topic is not affiliated with the social security system, or private about freedom;
- Subject refusing to participate in the study or not signing the informed consent;
- Subject with malignant disease known evolutionary
Key Trial Info
Start Date :
February 16 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2023
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT02296216
Start Date
February 16 2015
End Date
April 13 2023
Last Update
April 18 2023
Active Locations (1)
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1
Assistance Publique Hôpitaux de Marseille
Marseille, France, 13354