Micromegaly and Discrepancy Between Growth Hormone and IG... | NCT04860037

Studies
Micromegaly and Discrepancy Between Growth Hormone and IGF1 at the Diagnosis and Follow-up of Acromegalic Patients

NCT04860037

Sponsor

University Hospital, Montpellier

Status

Unknown status

Last Update Posted

Apr 26, 2021Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Acromegaly

Interventions

Not provided

Countries

France

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

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2010Actual

Primary Completion Date

Apr 1, 2022Estimated

Completion Date

Dec 1, 2022Estimated

First Submitted Date

Apr 22, 2021

First Submission Date that Met QC Criteria

Apr 22, 2021

First Posted Date

Apr 26, 2021Actual

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

Apr 22, 2021

Last Update Posted Date

Apr 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 diagnosis and the follow-up of acromegalic patients are based on the mesurement of Growth hormone (GH) and IGF1 rates. However, the literature described some cases of patient for whom the investigators observed a discrepancy between GH and IGF1 rates. Since the acromegaly is a rare disease and this phenomenon concerns about 30% of these patients, there is a lack of investigations about consequences that this discordance may induces. In this study, the investigators aimed at assessing if patients with discordance between GH and IGF1 rates present a different risk of recurrence and complications related to acromegaly, from patients with concordant results.

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

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

250Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of complications and/or recidivism related to acromegaly	The investigators check in the patient file if there is complications or pathology recidivism detected at the last full check-up of the disease, assessed by blood-control and complementary exams	day 1

Secondary Outcomes

Measure	Description	Time Frame
Disease's specificity	The investigators collected datas about disease's diagnosis (IRM characteristic, GH/IGF1 rates, clinical presentation) to evaluate if there is a different initial presentation between groups.	day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Acromegaly followed up in one of the center (Montpellier, Nimes or Béziers hospital, independent endocrinologist) between 2010 and 2021
Age over 18 years old
Measurement of GH and IGF1 rates at the last visit control available

Exclusion criteria:

Lost to follow-up
Status about complications related to acromegaly unknown

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Adult acromegalic patient followed up in the Occitanie region (independent endocrinologist ou working in hospital of Montpellier, Nimes or Béziers)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lucile MARTY, intern	Contact	06.71.31.76.37	33	lucile-marty@chu-montpellier.fr

Overall Officials

Name	Affiliation	Role
Isabelle RAINGEARD	University Hospital, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier	Recruiting	Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000172	Acromegaly

Ancestor Terms

ID	Term
D001849	Bone Diseases, Endocrine
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D006964	Hyperpituitarism

Browse Leaves

Not provided

Browse Branches

Not provided