Prospective Study of Clinically Nonfunctioning Pituitary Adenomas (PAPS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Pamela U. Freda, Columbia University
ClinicalTrials.gov Identifier:
NCT01556230
First received: March 9, 2012
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to carefully characterize the outcome of treatment for nonfunctioning pituitary adenomas. Pituitary adenomas are benign tumors of the pituitary gland. The study will follow 3 groups of patients with apparent pituitary adenomas (based on the MRI appearance and clinical presentation). One group of patients who will have surgery, a second who will not have surgery, and a third who have radiotherapy after surgery. The study will determine predictors of tumor growth and regrowth after surgery and if certain tumor markers can predict if the tumor will continue to grow. The study will determine whether the development of pituitary dysfunction, vision abnormalities or significant tumor growth differ between the no surgery, surgery, or radiation therapy groups. Patients in the study will also complete questionnaires on quality of life and memory function testing before and after the follow up or surgery or radiation treatment in order to determine if quality of life or memory are affected by these treatments.


Condition
Pituitary Adenoma
Pituitary Tumor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study of Clinically Nonfunctioning Pituitary Adenomas

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Pituitary tumor enlargement [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Number of patients with tumor enlargement over the study period

  • Development of hypopituitarism [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Number of patients with the development of hypopituitarism over the time frame.


Secondary Outcome Measures:
  • Neurocognitive function change [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Change in neurcognitive function test score over the time frame of the study.


Estimated Enrollment: 350
Study Start Date: March 2009
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Non-Surgery
Patients with clinically nonfunctioning pituitary adenomas may be treated with surgery or by observation alone depending on the tumor size and other factors. The decision whether or not to treat the tumor with surgery was made by the patient and their physicians. The purpose of this study is to carefully characterize the outcome of this conservative nonsurgical treatment including whether or not the tumor grows, if there is any change in hormone levels and whether surgery becomes necessary in the future.
Surgery
Patients with clinically nonfunctioning pituitary adenomas may be treated with surgery or by observation alone depending on the tumor size and other factors. The decision whether or not to treat the tumor with surgery is made by the patient and their physician. Patient who have decided to have surgery are invited to participate in this study that will evaluate the outcome of prospective follow up for you before and after surgery. The purpose of this study is to carefully characterize the outcome of surgical treatment including whether or not the tumor regrows, if the patient any change in hormone levels, and whether radiotherapy is needed in the future.
Radiotherapy (Radiation)
Patients with clinically nonfunctioning pituitary adenomas may be treated initially with surgery or by observation alone depending on the tumor size and other factors. Some patients receive radiotherapy at some time after the surgery was done, typically because the tumor could not be fully removed and/or has regrown. The decision whether or not to treat the tumor with radiotherapy was made by the patient and their physicians. As the patient has decided to have radiotherapy for their pituitary tumor they are being invited to participate in this study that will evaluate the outcome of prospective follow up for you before and after radiotherapy. The purpose of this study is to carefully characterize the outcome of radiotherapy treatment including whether or not the tumor regrows or if there is a change in hormone levels.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any persons diagnosed with a non-functioning pituitary adenoma that is willing to travel to our study center at Columbia University in New York, NY for all study visits.

Criteria

Inclusion Criteria:

  • Diagnosed with a pituitary tumor that does not secrete hormones AND
  • Men and women 18 years of age or older AND
  • Patient and their doctor have decided that the patient will have radiotherapy OR
  • Patient and their doctor have decided that the patient will have surgery OR
  • Patient and their doctor have decided that that the patient will have surgery
  • Pituitary lesion is greater than or equal to 7.0 mm in maximal diameter
  • Prolactin level is less than 100 ng/ml
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556230

Contacts
Contact: Amanda N Wade, MPH 212-305-7243 anw2124@columbia.edu
Contact: Jean Carlos Fernandez, MD 212-305-4921 sjf2132@columbia.edu

Locations
United States, New York
Columbia University College of Physicians & Surgeons Recruiting
New York, New York, United States, 10032
Contact: Amanda N. Wade, MPH    212-305-7243    anw2124@columbia.edu   
Contact: Jean Carlos Fernandez, MD    212-305-4921    sjf2132@columbia.edu   
Principal Investigator: Pamela U. Freda, MD         
Sub-Investigator: Sharon L Wardlaw, MD         
Sub-Investigator: Jeffrey N Bruce, MD         
Sub-Investigator: Steven R Isaacson, MD         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Pamela U. Freda, MD Columbia University College of Physicians&Surgeons
  More Information

No publications provided

Responsible Party: Pamela U. Freda, Associate Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01556230     History of Changes
Other Study ID Numbers: AAAE1260, R01NS070600
Study First Received: March 9, 2012
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Columbia University:
pituitary gland
pituitary adenoma
pituitary tumor
hypophysis
endocrine
neuroendocrine
hormone

Additional relevant MeSH terms:
Pituitary Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Pituitary Diseases
Adenoma
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypothalamic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 27, 2014