Prospective Study of Clinically Nonfunctioning Pituitary Adenomas

NCT01556230 | Completed

• 2 other identifiers: AAAE1260R01NS070600
• Study Type: observational
• Target: 292
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pituitary gland; pituitary adenoma; pituitary tumor; hypophysis; endocrine; neuroendocrine; hormone

Outcome Measures

Primary Outcomes (1)

• Number of patients with pituitary tumor enlargement

  Tumor enlargement over the study period

  5 years

Secondary Outcomes (1)

• Change in neurocognitive function test score

  Baseline, 5 years

Study Arms (2)

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.

Procedure: Surgical intervention for CNFA; Radiation: Radiotherapy for CNFA

Interventions

Surgical intervention for CNFA PROCEDURE

(non-experimental) standard procedure

Group II

Radiotherapy for CNFA RADIATION

(non-experimental) standard procedure

Group II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 for all study visits.

You may qualify if:

• adult patients with pituitary lesions that do not require surgical intervention.
• pituitary lesion that has been demonstrated on a magnetic resonance imaging (MRI) to be consistent with an adenoma (not a cystic lesion such as a Rathke's cleft cyst).
• patients with macroadenomas (\> 1 cm) or large microadenomas 6-9 mm.
• a prolactin level \< 40 ng/ml.

You may not qualify if:

• presence of visual or neurological deficits due to the tumor, tumor impingement on the optic chiasm and physical or laboratory abnormalities consistent with a biologically active hormone secreting tumor.
• GROUP II
• adult patients with pituitary lesions that require surgical intervention and are planning on surgery or who had surgery in the past and are now undergoing pituitary radiotherapy.
• pre-surgery patients will have a pituitary lesion that has been demonstrated on a MRI to be consistent with an adenoma (not a cystic lesion such as a Rathke's cleft cyst) and that is a macroadenoma (\> 1 cm).
• presence of visual or neurological deficits due to the tumor or impingement of the tumor on the optic chiasm is permitted.
• a prolactin level \< 100 ng/ml if lesion is \> or = 10 mm in size or a prolactin level \< 40 ng/ml if lesion is \< 10 mm in size.
• patients with mild/moderate hyperprolactinemia and recommended for dopamine agonist therapy (on the chance that the lesion is truly a prolactinoma) may re-enter the study should they be a dopamine agonist failure and require surgery.
• patients with hypopituitarism and no other surgical indication that choose to undergo surgery is permitted.

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Columbia University Vagelos College of Physicians & Surgeons

New York, New York, 10032, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Serum and Plasma samples

MeSH Terms

Conditions

Pituitary Neoplasms; Pituitary Diseases

Interventions

Surgical Procedures, Operative; Radiotherapy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Pamela U. Freda, MD

  Columbia University College of Physicians&Surgeons

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 9, 2012
• First Posted: March 16, 2012
• Study Start: November 1, 2010
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

US (1)