Retrospective Chart Review Study of Korlym for the Treatm... | NCT02663609

Studies
Retrospective Chart Review Study of Korlym for the Treatment of ACTH Independent Cushing's Syndrome

NCT02663609

Sponsor

Corcept Therapeutics

Status

Completed

Last Update Posted

Jun 1, 2023Actual

Enrollment

24Actual

Phase

Not provided

Conditions

Cushing's Syndrome

Interventions

No intervention

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Dec 1, 2017Actual

Completion Date

Dec 1, 2017Actual

First Submitted Date

Jan 8, 2016

First Submission Date that Met QC Criteria

Jan 21, 2016

First Posted Date

Jan 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2023

Last Update Posted Date

Jun 1, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Chart review study to collect patient data from medical charts of patients who have been treated with Korlym® for the treatment of ACTH independent adrenal Cushing's Syndrome.

Detailed Description

A retrospective, multi-center, chart review study to collect patient data from medical charts of patients who have been treated with Korlym® for the treatment of ACTH independent adrenal Cushing's Syndrome. Treatment with Korlym® will be a minimum 3 months in duration with follow-up of a minimum 3 months. Only sites that have been identified to have patients appropriate for this protocol will be invited to participate.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No treatment (intervention) was administered.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Drug Utilization Patterns as assessed by chart review	The retrospective review would analyze the drug utilization patterns of patients treated with Korlym	up to 4 years

Secondary Outcomes

Measure	Description	Time Frame
Clinical Outcomes as assessed by chart review	The retrospective review would analyze outcomes measures (vitals, clinical assessments, etc) in patients treated with Korlym	up to 4 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with ACTH independent endogenous Cushing's Syndrome
Available adrenal imaging prior to being treated with Korlym®
Treated with Korlym® and followed for at least 3 months (follow-up data should be available)

Exclusion Criteria:

Diagnosed with adrenocortical carcinoma
Participant in any clinical trial(s) during the observational period

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

ACTH Independent Cushing's Syndrome patients treated with Korlym® mifepristone) as standard of care in clinical practice.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003480	Cushing Syndrome

Ancestor Terms

ID	Term
D000308	Adrenocortical Hyperfunction
D000307	Adrenal Gland Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided