HypercortisolismNCT03379363
Retrospective Chart Review Study of Pediatric Patients Treated With Korlym for Cushing Syndrome
An observational study of Hypercortisolism and Cushing Syndrome, run by Corcept Therapeutics at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Hypercortisolism, Cushing Syndrome
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2017to 12 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients who have been treated with Korlym for Cushing's syndrome
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- Hypercortisolism, Cushing Syndrome
- Keywords
- cushing syndrome, hypercortisolism
- Medical subject headings
- Cushing Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Cushing Syndrome Patients | Pediatrics patients with endogenous Cushing syndrome who received at least one dose of Korlym |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug utilization patterns as assessed by chart review
The retrospective review would analyze the drug utilization patterns of pediatric patients treated with Korlym
Measured: Length of Korlym therapy, up to 5 years
Secondary outcomes (2)
Weight as assessed by chart review
The retrospective review would analyze changes in Weight (in kg) in pediatric patients treated with Korlym
Measured: Length of Korlym therapy, up to 5 years
Blood Pressure as assessed by chart review
The retrospective review would analyze changes in Blood Pressure (in mmHg) in pediatric patients treated with Korlym
Measured: Length of Korlym therapy, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start18 Sep 2017
- Primary completion12 Feb 2018
- Study completion12 Feb 2018
Why it stopped: Insufficient number of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercortisolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379363
- Sponsor's protocol ID
- C1073-900
- Status last verified
- Jul 2019
- First submitted
- 24 Oct 2017
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Chart Review Study of Pediatric Patients Treated With Korlym for Cushing Syndrome
- ClinicalTrials.gov ID
- NCT03379363
- Acronym / sponsor ID
- C1073-900
- Conditions
- Hypercortisolism, Cushing Syndrome
- Keywords
- cushing syndrome, hypercortisolism
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient number of patients
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 12 Feb 2018 (actual)
- Study completion
- 12 Feb 2018 (actual)
- First posted
- 20 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Cushing Syndrome Patients | – | –Pediatrics patients with endogenous Cushing syndrome who received at least one dose of Korlym |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients who have been treated with Korlym for Cushing's syndrome
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Drug utilization patterns as assessed by chart review
Time frame: Length of Korlym therapy, up to 5 years
The retrospective review would analyze the drug utilization patterns of pediatric patients treated with Korlym
2 secondary outcomes
Weight as assessed by chart review
Time frame: Length of Korlym therapy, up to 5 years
Blood Pressure as assessed by chart review
Time frame: Length of Korlym therapy, up to 5 years
Results and safety
The study was stopped early (reason given: Insufficient number of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercortisolism and Cushing Syndrome, run by Corcept Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient number of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug utilization patterns as assessed by chart review (time frame: Length of Korlym therapy, up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.