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Prospective Study of Clinically Nonfunctioning Pituitary Adenomas

NCT01556230 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 292

Last updated 2024-06-25

No results posted yet for this study

Summary

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.

Conditions

  • Pituitary Adenoma
  • Pituitary Tumor

Interventions

PROCEDURE

Surgical intervention for CNFA

(non-experimental) standard procedure

RADIATION

Radiotherapy for CNFA

(non-experimental) standard procedure

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Pamela U. Freda, MD · Columbia University College of Physicians&Surgeons

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01556230 on ClinicalTrials.gov