Clinical Trial: Treatment Patterns and Treatment Outcomes for Acromegaly

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Treatment Patterns and Treatment Outcomes in a New York City Based Cohort of 520 Patients With Acromegaly

Brief Summary: This is a human, prospective and retrospective, single-center study of patients who have undergone treatment for acromegaly in New York City since 1981. The project will characterize, among other factors, the treatment methods received by patients, who administered the treatments and the success of this therapy in terms of biochemical control.

Detailed Summary:

The first phase of this study will be to contact all subjects in the cohort by a mailing introducing them to the study. This will be followed by a phone call and administration of a questionnaire by phone or by mail. The questionnaire will collect current information on acromegaly treatment, morbidities other relevant history. Subjects will provide verbal consent to participate in this questionnaire part of the study and review of their medical records by the Principal Investigator (PI) and study staff.

In the second phase of the study, subjects will be invited to come for a visit that will be conducted by the PI and study staff at the Pituitary Center of Columbia University Medical Center. At this visit written informed consent will be obtained. The investigators will review the subjects' medical history that is obtained from the subject and review any records and laboratory test results provided by the subject and conduct clinical and laboratory assessments. Although all subjects participating in Phase 1 will be invited to participate, it is estimated that 120 of the subjects invited will come for the one visit over the 2-year time frame of this study.

In the third phase of the study a chart review for collection will be conducted and all data will be compiled. All subjects agreeing to participate, both in person and by mail, a chart review of all relevant patient data including demographic, clinical, biochemical, surgical and follow up information. Data from questionnaires and record reviews will be compiled for analysis.


Sponsor: Columbia University

Current Primary Outcome: Frequency of each type of acromegaly therapy in the cohort. [ Time Frame: At 5 years of therapy ]

Determine rates of treatment by surgery alone, somatostatin analog, pegvisomant, radiotherapy and combinations of each of these therapies in the cohort.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Hypertension [ Time Frame: at 5 years of therapy ]
    Rate of hypertension in each acromegaly therapy group
  • Diabetes Mellitus [ Time Frame: at 5 years of therapy ]
    Rate of diabetes mellitus by ADA criteria in each acromegaly therapy group
  • Sleep apnea [ Time Frame: at 5 years of therapy ]
    Rate of sleep apnea diagnosis in each acromegaly therapy group
  • IGF-1 level normalization [ Time Frame: at 5 years of therapy ]
    Rate of IGF-1 normalization in each acromegaly therapy group


Original Secondary Outcome: Same as current

Information By: Columbia University

Dates:
Date Received: January 30, 2017
Date Started: December 2016
Date Completion: July 2017
Last Updated: February 2, 2017
Last Verified: January 2017