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| Name | Class |
|---|---|
| Ipsen | INDUSTRY |
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This is a human, prospective and retrospective, single-center study of patients who have undergone treatment for acromegaly in New York City since 1981. The project will characterize, among other factors, the treatment methods received by patients, who administered the treatments and the success of this therapy in terms of biochemical control.
The first phase of this study will be to contact all subjects in the cohort by a mailing introducing them to the study. This will be followed by a phone call and administration of a questionnaire by phone or by mail. The questionnaire will collect current information on acromegaly treatment, morbidities other relevant history. Subjects will provide verbal consent to participate in this questionnaire part of the study and review of their medical records by the Principal Investigator (PI) and study staff.
In the second phase of the study, subjects will be invited to come for a visit that will be conducted by the PI and study staff at the Pituitary Center of Columbia University Irving Medical Center. At this visit written informed consent will be obtained. The investigators will review the subjects' medical history that is obtained from the subject and review any records and laboratory test results provided by the subject and conduct clinical and laboratory assessments. Although all subjects participating in Phase 1 will be invited to participate, it is estimated that 120 of the subjects invited will come for the one visit over the 2-year time frame of this study.
In the third phase of the study a chart review for collection will be conducted and all data will be compiled. All subjects agreeing to participate, both in person and by mail, a chart review of all relevant patient data including demographic, clinical, biochemical, surgical and follow up information. Data from questionnaires and record reviews will be compiled for analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Pattern | The first phase of this study will be to contact all subjects in the cohort by a mailing introducing them to the study. This will be followed by a phone call and administration of a questionnaire by phone or by mail. A phone script will be utilized to obtain verbal informed consent from subjects for this phase of the study. The questionnaire will collect current information on acromegaly treatment, morbidities and other relevant history. Subjects will provide verbal consent to participate in this questionnaire part of the study and review of their medical records by the PI and study staff. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients that have received surgery as first line therapy | Frequency of each type of acromegaly therapy and rates of treatment by surgery alone, somatostatin analog, pegvisomant, radiotherapy and combinations of each of these therapies in the cohort will be recorded and determined. The expected result is that more than 90% of our cohort has received surgery as first line therapy and only a minority has received primary medical therapy. | At 5 years of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with IGF-1 levels remaining elevated | This is to identify patients who are not optimally managed since their IGF-1 levels remain elevated. | At 5 years of therapy |
| Hypertension Rate |
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Inclusion Criteria:
Exclusion Criteria:
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The population for this study is a cohort of 520 adult patients who have undergone treatment for acromegaly in NYC since 1981. The cohort is predetermined based on the patients who have previously undergone pituitary surgery for acromegaly with our two collaborating Neurosurgeons. Based on prior studies, the population has no gender predilection and no racial or ethnic predisposition and thus the ethnic mix of the cohort reflects the population of the NY metropolitan area that is referred to the study center.
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| Name | Affiliation | Role |
|---|---|---|
| Pamela U Freda, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuroendocrine Unit at Columbia University Irving Medical Center | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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Blood will be sampled for fasting measurements of growth hormone (GH) and insulin Growth Factor 1 (IGF-1) and patients will undergo an oral glucose tolerance test (OGTT) with blood drawn before and 60, 90 and 120 minutes after a 75 g. dextrose drink.
This is to identify if hypertension is affected by how treatment is managed.
| At 5 years of therapy |
| Diabetes Mellitus Rate | This is to identify if diabetes mellitus is affected by how treatment is managed. | At 5 years of therapy |
| Sleep Apnea Rate | This is to identify if sleep apnea is affected by how treatment is managed. | At 5 years of therapy |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |