Characterization of Receptors in Non-functioning Pituitary Macroadenomas

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by John H. Stroger Hospital
Sponsor:
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Leon Fogelfeld, John H. Stroger Hospital
ClinicalTrials.gov Identifier:
NCT00852501
First received: February 26, 2009
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Pituitary Tumor
Other: To perform RT-PCR on the tissue obtained during surgery
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Receptors Present in Non-functioning Pituitary Macroadenomas by Reverse Transcriptase- Polymerase Chain Reaction (RT-PCR)

Resource links provided by NLM:


Further study details as provided by John H. Stroger Hospital:

Primary Outcome Measures:
  • To determine the expression of hormonal receptors in clinically non-functioning pituitary macroadenomas by RT - PCR and immunohistochemistry. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To correlate the clinical, hormonal and radiological characteristics of the patients with pituitary tumors with the hormonal receptors status. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

A small piece of the pituitary macradenoma removed at surgery will be frozen to perform RT-PCR


Estimated Enrollment: 100
Study Start Date: March 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Reverse Transcriptase polymerase chain reaction

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.

  Eligibility

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

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

Criteria

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
  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: NCT00852501

Contacts
Contact: Ambika Babu, MD 312 864 0543 Ambika_Babu@rush.edu
Contact: Leon A Fogelfeld, MD 312 864 0540 lfogelfe@cchil.org

Locations
United States, Illinois
John H Stroger Jr. Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612
Contact: Ambika Babu, MD    312-864-0543    Ambika_Babu@rush.edu   
Principal Investigator: Ambika Babu, MD         
Sponsors and Collaborators
John H. Stroger Hospital
University of Illinois at Chicago
Investigators
Principal Investigator: Ambika Babu, MD John H Stroger Jr. Hospital of Cook County
  More Information

No publications provided

Responsible Party: Leon Fogelfeld, M.D., John H. Stroger Hospital
ClinicalTrials.gov Identifier: NCT00852501     History of Changes
Other Study ID Numbers: 06-044
Study First Received: February 26, 2009
Last Updated: April 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by John H. Stroger Hospital:
Non-functioning pituitary adenoma
RTPCR
Hormonal receptors

Additional relevant MeSH terms:
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Pituitary Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypothalamic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014