Characterization of Receptors in Non-functioning Pituitary Macroadenomas

Pituitary Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00852501
• Other study ID #: 06-044
• Status: Recruiting
• Phase: Phase 4
• First received: February 26, 2009
• Last updated: April 8, 2013
• Start date: March 2006
• Est. completion date: December 2013

Study information

• Verified date: April 2013
• Source: John H. Stroger Hospital
• Contact: Ambika Babu, MD
• Phone: 312 864 0543
• Email: Ambika_Babu[@]rush.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pituitary Diseases
• Pituitary Neoplasms
• Pituitary Tumor

Intervention

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.

Locations

Country	Name	City	State
United States	John H Stroger Jr. Hospital of Cook County	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
John H. Stroger Hospital	University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the expression of hormonal receptors in clinically non-functioning pituitary macroadenomas by RT - PCR and immunohistochemistry.		2 years	No
Secondary	To correlate the clinical, hormonal and radiological characteristics of the patients with pituitary tumors with the hormonal receptors status.		2 years	No