Characterization of Receptors in Non-functioning Pituitary Macroadenomas

Characterization of Receptors Present in Non-functioning Pituitary Macroadenomas by Reverse Transcriptase- Polymerase Chain Reaction (RT-PCR)

Characterization of receptors present in non-functioning pituitary macroadenomas by Reverse Transcriptase- Polymerase Chain Reaction (RT-PCR) would assist with targeted medical therapy based on the information obtained by immunohistochemistry and RT-PCR.

Study Overview

• Status: Unknown
• Conditions: Pituitary Tumor
• Intervention / Treatment: Other: To perform RT-PCR on the tissue obtained during surgery

Detailed Description

The pituitary gland in the brain is the master hormonal gland and is surrounded by important nerves and blood vessels. The pituitary gland can develop various types of tumors, some which do not produce any hormones and are called non-functioning pituitary adenomas. These non-functioning tumors can grow and can cause compression of these important structures. The usual treatment of large non-functioning pituitary macroadenoma is surgery. As it is surrounded by neuro-vascular bundles, this makes complete removal of the tumor sometimes impossible and even dangerous. A large number of subjects will still have some residual tumor post-surgery. The risks of residual tumor are further growth with compression and compromise of the function of surrounding vital organs especially vision.

If there is further growth of the tumor the options at present are repeat surgery or radiotherapy. Repeat surgery involves all the risks associated with brain surgery and sometimes may not be possible if very close to vital organs, while radiotherapy will over a period of time lead to complete or partial deficiency of pituitary hormone function and has been associated with long term cognitive deficits. In addition radiotherapy has a lag time of 12-24 months prior to onset of action.

However, pituitary tumors that do not actively secrete hormones may still harbour receptors to various hormones. The blockage of these receptors by various medications may enable us to stop the tumor from growing or recurring after surgery. This may open up a novel means of treatment of these non functioning tumors. So far there is very little information in the literature about the type of receptors present in these tumors.

Our study proposes to obtain a piece of the tissue removed during surgery and perform receptor characterization to help improve our knowledge in that area. Also correlating the receptor status with the clinical, hormonal and radiological profile of the patients may help to develop improved treatment strategies in the future and help us to predict the possibility of tumor regrowth.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Ambika Babu, MD; Phone Number: 312 864 0543; Email: Ambika_Babu@rush.edu
• Study Contact Backup: Name: Leon A Fogelfeld, MD; Phone Number: 312 864 0540; Email: lfogelfe@cchil.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • John H Stroger Jr. Hospital of Cook County
      • Contact: Ambika Babu, MD; Phone Number: 312-864-0543; Email: Ambika_Babu@rush.edu
      • Principal Investigator: Ambika Babu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All subjects who are diagnosed with a non-functioning pituitary macroadenoma who are scheduled for surgery.

Description

Inclusion Criteria:

1. Adults, both males and females age 18 years old or more
2. Pituitary tumor more than 10 mm in diameter diagnosed by MRI
3. No clinical or laboratory evidence of pituitary hormone oversecretion (non-functioning pituitary macroadenoma)

Exclusion Criteria:

1. Subjects with pituitary tumors less than 10 mm in diameter
2. Subjects with clinical or laboratory evidence of hormone oversecretion
3. Presence of dementia

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-functioning pituitary macroadenoma; The performance of surgery is the standard of care in the management of non-functioning pituitary macroadenomas. The tissue obtained during surgery is routinely sent for histopathological examination. A piece of the tissue will undergo receptor characterisation via RT-PCR.	Other: To perform RT-PCR on the tissue obtained during surgery; The performance of surgery is the standard of care in the management of non-functioning pituitary macroadenomas. The tissue obtained during surgery is routinely sent for histopathological examination. A piece of the tissue will undergo receptor characterisation via RT-PCR.; Other Names: Reverse Transcriptase polymerase chain reaction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the expression of hormonal receptors in clinically non-functioning pituitary macroadenomas by RT - PCR and immunohistochemistry.	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
To correlate the clinical, hormonal and radiological characteristics of the patients with pituitary tumors with the hormonal receptors status.	2 years

Collaborators and Investigators

• Sponsor: John H. Stroger Hospital
• Collaborators: University of Illinois at Chicago
• Investigators: Principal Investigator: Ambika Babu, MD, John H. Stroger Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: February 26, 2009
• First Submitted That Met QC Criteria: February 26, 2009
• First Posted (Estimate): February 27, 2009

Study Record Updates

• Last Update Posted (Estimate): April 9, 2013
• Last Update Submitted That Met QC Criteria: April 8, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: RTPCR; Non-functioning pituitary adenoma; Hormonal receptors
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Hypothalamic Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Pituitary Neoplasms; Pituitary Diseases
• Other Study ID Numbers: 06-044