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| ID | Type | Description | Link |
|---|---|---|---|
| R01NS070600 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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This project is the first comprehensive prospective study of clinically non-functioning pituitary adenomas (CNFAs). Two groups of subjects will be studied: Group I will consist of 100 patients with clinically non-functioning (CNF) pituitary lesions who are asymptomatic and do not require surgery; Group II will consist of 250 patients who have pituitary lesions that are symptomatic and require surgery. Patients will be followed with a series of endocrine laboratory testing, physical examinations, testing of quality of life and neurocognitive function before and serially over time either during non-surgical management or after surgery and in some patients before and after radiotherapy (RT). Data on pituitary magnetic resonance imaging (MRI) studies and visual field testing being done over time during follow up as part of clinical care will be collected.
PROTOCOL I: Prospective Study of the outcome of conservative non-surgical management of patients with asymptomatic, clinically non-functioning (CNF) pituitary lesions. This protocol will evaluate prospectively the outcome of non-surgical management of clinically non-functioning pituitary lesions that do not appear to need surgery as their initial therapy. The overall design consists of an initial baseline evaluation and then serial prospective follow up studies over time for up to 5 years of follow up. The study will evaluate laboratory testing, clinical examinations, quality of life and neurocognitive function in these patients. Data will be collected on visual fields and MRI studies of the pituitary tumor that are done prospectively as part of clinical care to evaluate these patients.
PROTOCOL II : Prospective study of the outcome of patients with symptomatic, clinically non-functioning pituitary tumors who are treated with transsphenoidal surgery and in some cases also radiotherapy. This protocol will evaluate prospectively the outcome of surgical management of asymptomatic clinically nonfunctioning pituitary lesions. The overall design consists of an initial baseline evaluation and then serial prospective follow up studies over time with up to 5 years of follow up. The study will evaluate laboratory testing, clinical examinations, quality of life and neurocognitive function in these patients. Data will also be collected on visual fields and MRI studies of the pituitary tumor that are done prospectively as part of clinical care to evaluate these patients. Data will be analyzed to determine the safety of observation alone following surgery for patients who do not have a clinically significant tumor remnant, if the silent corticotroph tumor type is characterized by elevated plasma levels of ACTH or its precursor, POMC, and if it is associated with an increased tumor recurrence rate. A group of patients who are planning RT will also be studied by these same procedures before and after RT in order to determine if the outcomes of patients who receive RT for treatment of tumor re-growth to that of those who do not receive RT with respect to further tumor growth, endocrine or neurological dysfunction. Quality of life and neurocognitive function in patients with clinically non-functioning pituitary lesions treated with surgery alone or those who also receive radiotherapy will be prospectively assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | The first group of subjects, Group I, will be followed in Protocol I and are a group of subjects with an apparent clinically nonfunctioning pituitary lesion who will be studied in a prospective study of conservative non-surgical management. | ||
| Group II | A second group of subjects, Group II, are subjects who are undergoing surgical intervention for CNFA or radiotherapy for CNFA and these subjects will be studied in a prospectively follow up as part of Protocol II. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical intervention for CNFA | Procedure | (non-experimental) standard procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with pituitary tumor enlargement | Tumor enlargement over the study period | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in neurocognitive function test score | Neurocognitive function change over the time frame of the study | Baseline, 5 years |
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GROUP I
Inclusion Criteria:
Exclusion Criteria:
GROUP II
Inclusion Criteria:
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Any persons diagnosed with a non-functioning pituitary adenoma that is willing to travel to our study center at Columbia University in New York for all study visits.
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| Name | Affiliation | Role |
|---|---|---|
| Pamela U. Freda, MD | Columbia University College of Physicians&Surgeons | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Vagelos College of Physicians & Surgeons | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D010911 | Pituitary Neoplasms |
| D010900 | Pituitary Diseases |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007029 | Hypothalamic Neoplasms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Blood Serum and Plasma samples
| Radiotherapy for CNFA |
| Radiation |
(non-experimental) standard procedure |
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| D015173 |
| Supratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007027 | Hypothalamic Diseases |
| D004700 | Endocrine System Diseases |