Retrospective Chart Review Study of Pediatric Patients Treated With Korlym for Cushing Syndrome

NCT ID: NCT03379363

Last Updated: 2019-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-18

Study Completion Date

2018-02-12

Brief Summary

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This retrospective, multi-center, chart review study will collect patient data from medical charts of pediatric patients who have been treated with Korlym for Cushing's syndrome.

Detailed Description

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This retrospective chart review study seeks to collect data from pediatric patients treated with Korlym (mifepristone) to help provide clinicians with some insight on the potential role of mifepristone in the treatment of pediatric patients with Cushing syndrome.

Only sites that have been identified to have patients appropriate for this protocol will be invited to participate and contribute data on their patients

Data to be collected from a retrospective chart review will include:

* Patient demographics
* Medical history
* Pre and post treatment clinical assessments and laboratory results
* Radiologic findings (if available)
* Adverse events

Data will be collected for all follow-up visits, up until the most recent encounter prior to IRB approval.

Conditions

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Hypercortisolism Cushing Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Pediatric Cushing Syndrome Patients

Pediatrics patients with endogenous Cushing syndrome who received at least one dose of Korlym

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Pediatrics (age≤21 years) at time Korlym initiation
* Considered to have a diagnosis of endogenous Cushing's syndrome by the healthcare provider
* Received at least one dose of Korlym
* Availability of pre-treatment (baseline) and follow-up data

Exclusion Criteria

* None
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corcept Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Corcept Therapeutics

Menlo Park, California, United States

Site Status

Countries

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United States

Other Identifiers

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C1073-900

Identifier Type: -

Identifier Source: org_study_id

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