Prospective Study of Clinically Nonfunctioning Pituitary Adenomas (PAPS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01556230|
Recruitment Status : Recruiting
First Posted : March 16, 2012
Last Update Posted : February 19, 2019
|Condition or disease||Intervention/treatment|
|Pituitary Adenoma Pituitary Tumor||Procedure: Surgical intervention for CNFA Radiation: Radiotherapy for CNFA|
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.
|Study Type :||Observational|
|Estimated Enrollment :||350 participants|
|Official Title:||Prospective Study of Clinically Nonfunctioning Pituitary Adenomas|
|Actual Study Start Date :||November 2010|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
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.
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.
Procedure: Surgical intervention for CNFA
(non-experimental) standard procedure
Radiation: Radiotherapy for CNFA
(non-experimental) standard procedure
- Number of patients with pituitary tumor enlargement [ Time Frame: 5 years ]Tumor enlargement over the study period
- Change in neurocognitive function test score [ Time Frame: Baseline, 5 years ]Neurocognitive function change over the time frame of the study
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556230
|Contact: Carlos M Reyes-Vidal, MDfirstname.lastname@example.org|
|Contact: Wayna Paulino, MDemail@example.com|
|United States, New York|
|Columbia University Vagelos College of Physicians & Surgeons||Recruiting|
|New York, New York, United States, 10032|
|Contact: Carlos M Reyes-Vidal, MD 212-305-4921 firstname.lastname@example.org|
|Contact: Krystal Hernandez, MD 212-305-4921 email@example.com|
|Principal Investigator: Pamela U. Freda, MD|
|Sub-Investigator: Sharon L Wardlaw, MD|
|Sub-Investigator: Jeffrey N Bruce, MD, FACS|
|Sub-Investigator: Yaakov Stern, PhD|
|Principal Investigator:||Pamela U. Freda, MD||Columbia University College of Physicians&Surgeons|