NCT03043586

Treatment Patterns and Treatment Outcomes for Acromegaly

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 520 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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 Irving 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.

Conditions

• Acromegaly

Timeline

• Start date: 2016-12-01
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2017-02-06
• Last updated: 2025-05-13

Locations

1 site across 1 country: United States