Long-term Cardiovascular Risk in Cured Cushing's Patients | NCT00881283

Studies
Long-term Cardiovascular Risk in Cured Cushing's Patients

NCT00881283

Sponsor

Massachusetts General Hospital

Status

Terminated

Last Update Posted

Sep 2, 2020Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Cushing's Disease

Interventions

Not provided

Countries

United States

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

Aug 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Decision made to close study early.

Expanded Access Info

Start Date

Sep 8, 2008Actual

Primary Completion Date

Mar 30, 2010Actual

Completion Date

Mar 30, 2010Actual

First Submitted Date

Apr 13, 2009

First Submission Date that Met QC Criteria

Apr 13, 2009

First Posted Date

Apr 15, 2009Estimated

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

Aug 31, 2020

Last Update Posted Date

Sep 2, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Karen Klahr Miller, MD, Chief, Neuroendocrine Unit, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Not provided

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

The purpose of this study is to determine whether subjects who have been affected by Cushing's disease in the past maintain some different characteristics compared with subjects who have never been diagnosed with the disease.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1Actual

Label	Type	Description	Intervention Names
cured Cushing's disease

Measure	Description	Time Frame
adipokine measurements		baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who have been cured of Cushing's disease at least 5 years ago.

Exclusion Criteria:

patients who have been cured of Cushing's disease more than 15 years ago.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Cured Cushing's disease

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne Klibanski, MD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neuroendocrine Clinical Center		Boston	Massachusetts	02114	United States

Condition Browse Module

MeSH Terms

ID	Term
D047748	Pituitary ACTH Hypersecretion

Ancestor Terms

ID	Term
D006964	Hyperpituitarism
D010900	Pituitary Diseases
D007027	Hypothalamic Diseases
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided