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Long Term Outcome Study in Patients With Pituitary Disorders

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ClinicalTrials.gov Identifier: NCT03665064
Recruitment Status : Active, not recruiting
First Posted : September 11, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Brief Summary:
To determine the outcomes of patients with different pituitary disorders whether they are managed medically, surgically or expectantly.

Condition or disease
Pituitary Diseases Pituitary Neoplasms

Detailed Description:
A chart audit of around 1500 patients seen in two specific clinics, the Medical Pituitary Clinic and the combined Endocrine/Neurosurgical Pituitary Clinic at the University of Alberta Hospital, will be performed to determine the effectiveness of various treatment strategies on the long term outcome of specific pituitary disorders. The investigator's will collect retrospective demographic (age, sex, ethnicity), clinical (mode of presentation, hormonal parameters) and therapeutic outcome (surgical, medical, expectant and / or radiation treatment; co-morbidities and complications) of patients seen in these two clinics between January 2000 and December 2017.

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long Term Outcome Study in Patients With Pituitary Disorders
Actual Study Start Date : January 1, 2000
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020





Primary Outcome Measures :
  1. Progression free survival after pituitary surgery [ Time Frame: up to 17 years post surgery ]
    Using clinical, biochemical and imaging studies of a cohort of surgically operated patients to identify prognostic factors of tumor recurrence



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
tertiary referral center
Criteria

Inclusion Criteria:

  • patients with confirmed pituitary disease

Exclusion Criteria:

  • patients who do not have confirmed pituitary disease

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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03665064     History of Changes
Other Study ID Numbers: Pro00048323
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Alberta:
Pituitary tumor
Acromegaly
Cushing
Prolactinoma

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