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A Prospective Study of Outcome After Therapy for Acromegaly

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Columbia University
Sponsor:
Collaborator:
Mount Sinai School of Medicine
Information provided by (Responsible Party):
Pamela U. Freda, Columbia University
ClinicalTrials.gov Identifier:
NCT01809808
First received: August 8, 2012
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

Acromegaly is a condition in which too much growth hormone is made by a tumor of the pituitary gland. Patients with inadequately treated acromegaly may have a higher chance of a number of other diseases such as heart disease, diabetes as well as a shortened life expectancy. The purpose of this study is to carefully characterize the blood levels of hormones and other substances in the blood in patients with acromegaly over time so that we can gain a better understanding of those factors responsible for the excess morbidity and mortality in acromegaly.

This study will follow acromegaly subjects during the therapy which has been decided by the patient and patient's physician. This study will not provide therapy for acromegaly. A patient qualifies as a possible study participant because the patient have been diagnosed with acromegaly.


Condition
Acromegaly

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Outcome After Therapy for Acromegaly

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Assessment of biochemical activity of acromegaly. [ Time Frame: At 5 years after therapy for acromegaly. ] [ Designated as safety issue: No ]
    The study will assess the status of biochemical disease activity of acromegaly before and after treatment for acromegaly. Blood samples are taken for fasting growth hormone and insulin-like growth factor 1 and growth hormone levels 60, 90 and 120 minutes after oral glucose.taken at baseline visit, post-operative month 1(fasting blood only), post-operative month 3(fasting blood only), post-operative month 6, post-operative month 12, and annual assessments for at least 5 years.


Biospecimen Retention:   Samples Without DNA

Serum and blood samples


Estimated Enrollment: 250
Study Start Date: September 2003
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acromegaly Subjects
Healthy Subjects

Detailed Description:

Patients will be seen at diagnosis and over time after surgery if they are newly diagnosed or if they have already undergone surgery they will be seen over time after surgery. Visits will occur preoperatively and at 1, 3, 6, 12 months after surgery and then yearly for at least 5 years after that. Subjects who enter the study 1 year after surgery or later will be seen yearly for at least 5 years .

At each visit subjects will have an interview and examination with Dr. Freda or her research staff, will complete a questionnaire about symptoms of acromegaly. You will also have two teaspoons of blood drawn for measurement of the hormones listed above. At the 3 month and 12 month visits subjects will also have blood drawn for measurement of growth hormone and other hormones at 60, 90 and 120 minutes after they drink an 8 ounce glass of sugar solution (OGTT).

About 6 teaspoons of blood will be drawn at these visits.

Subjects will then invited to come at yearly visits for the same procedures as listed above including the questionnaires, examination and blood testing including a OGTT. At your discretion or at the discretion of the research team the interval may be lengthened to every 2 to 3 years at some time in the future. It is expected that this study will continue for at least five years, but it may go beyond this time period.

If subjects receive another form of therapy for acromegaly visits will take place at the time intervals above during the course of your therapy.

If subjects have undergone surgery at some time in the past they may join the study at any point in itscourse and undergo the procedures described above as appropriate

  Eligibility

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

Subjects newly diagnosed with acromegaly or who have previously undergone surgery for acromegaly are invited to participate. Acromegaly subjects will be recruited primarily from the patients who present to Dr. Jeffrey Bruce at Columbia Presbyterian Medical Center, Dr. Kalmon Post at Mount Sinai Medical Center for Neurosurgery or to the Principal Investigator Dr. Pamela Freda at the Neuroendocrine Unit at Columbia Presbyterian Medical Center for evaluation of acromegaly. Subjects who have undergone surgery with other surgeons or followed by other Endocrinologists may be considered for participation.

Criteria

Inclusion Criteria:

  • Adult males and females
  • Ages 18 and over
  • Presenting to the PI or one of the sub-investigators for evaluation of acromegaly or for study participation to the PI or a sub-investigator.
  • Must have a biochemical diagnosis of acromegaly consisting of an elevated serum IGF-I level. Supportive although not required for entry are an elevated GH level and a failure of GH to suppress normally after oral glucose administration
  • Willingness to participate in this study's procedures

Exclusion Criteria:

  • Subjects who are unwilling to comply with the procedures outlined in the study.
  • Subjects who do not have the ability to fully comprehend the nature of the study, to follow instructions, and/or cooperate with study procedures
  • Are unwilling to provide informed consent to participate in the study
  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: NCT01809808

Contacts
Contact: Pamela U Freda, M.D. 212-305-2254 puf1@columbia.edu

Locations
United States, New York
Neuroendocrine Unit; Columbia University Medical Center, 180 Fort Washington Avenue 9-970 Recruiting
New York, New York, United States, 10032
Contact: Carlos Reyes-Vidal, MD    212-305-4921      
Contact: Jean Carlos Fernandez, MD    212-305-4921      
Principal Investigator: Pamela U Freda, M.D.         
Sponsors and Collaborators
Columbia University
Mount Sinai School of Medicine
Investigators
Principal Investigator: Pamela U Freda, M.D. Columbia University
  More Information

Additional Information:
No publications provided

Responsible Party: Pamela U. Freda, Associate Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01809808     History of Changes
Other Study ID Numbers: AAAA0890
Study First Received: August 8, 2012
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Acromegaly, Pituitary tumor

Additional relevant MeSH terms:
Acromegaly
Bone Diseases
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hyperpituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases

ClinicalTrials.gov processed this record on November 20, 2014