Treatment Patterns and Treatment Outcomes for Acromegaly

  • STATUS
    Recruiting
  • End date
    Jul 21, 2023
  • participants needed
    520
  • sponsor
    Columbia University
Updated on 21 July 2021
pituitary

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.

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.

Details
Condition Acromegaly
Clinical Study IdentifierNCT03043586
SponsorColumbia University
Last Modified on21 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult males and females
Ages 18 and over
Presenting to the PI or one of the sub-investigators for evaluation of acromegaly
Must be an Acromegaly subject that have undergone Pituitary surgery with Dr. Bruce or Dr. Post or Present it to principal investigator Dr. Pamela Freda at the Neuroendocrine Unit at Columbia University Medical Center for evaluation of Acromegaly

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
Not being treated for acromegaly either by Dr. Bruce, Dr. Post or Dr. Freda
Are unwilling to provide informed consent to participate in the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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