SAGIT for Classification of Patients With Acromegaly in C... | NCT02231593

Studies
SAGIT for Classification of Patients With Acromegaly in Clinical Practice

NCT02231593

Sponsor

Ipsen

Status

Completed

Last Update Posted

Mar 31, 2020Actual

Enrollment

71Actual

Phase

Not provided

Conditions

Acromegaly

Interventions

SAGIT

Countries

United States
Brazil
France
Germany
Italy
Spain
United Kingdom

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

Mar 2020

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

Feb 2013

Primary Completion Date

May 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Sep 2, 2014

First Submission Date that Met QC Criteria

Sep 2, 2014

First Posted Date

Sep 4, 2014Estimated

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

Mar 30, 2020

Last Update Posted Date

Mar 31, 2020Actual

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 pilot study is to test SAGIT (Signs and symptoms - Associated comorbidities - GH concentration level - IGF-1 - Tumour). SAGIT is a Clinician-Reported Outcomes (ClinROs) tool developed to describe patients with acromegaly. This study will determine the potential use of a finalised operational version for patient classification in clinical practice and studies.

In addition, this study intends to carry out a qualitative evaluation of the acceptability of SAGIT by the practicing endocrinologist in terms of relevance, ease of use, applicability and usefulness of the tool in practice.

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

71Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acromegalic patients			Other: SAGIT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SAGIT	Other	SAGIT is a Clinician-Reported Outcomes (ClinROs) tool	Acromegalic patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of acromegaly patients classified using SAGIT		8 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female aged 18 years-old or above
Patient with diagnosis of acromegaly with the presence of pituitary adenoma, elevated IGF-1 and lack of serum GH suppression after oral glucose tolerance test (OGTT)
Controlled/stable, active and treatment naïve patients.
Patient with the cognitive and linguistic capacities to understand the information letter of the study
Patient who signed informed consent

Exclusion Criteria:

History of non-compliance or inability to reliably receive treatment in the foreseeable future
Gaps in treatment of greater than 1 month within the 12 months prior to study entry

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Acromegaly patients registered with endocrinologists (hospital-based or outpatient clinics)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ipsen Study Director	Ipsen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cedars-Sinai Medical Center		Los Angeles	California	90048	United States
NW Pituitary Center and Neurological Surgery

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26377024	Derived	Giustina A, Bevan JS, Bronstein MD, Casanueva FF, Chanson P, Petersenn S, Thanh XM, Sert C, Houchard A, Guillemin I, Melmed S; SAGIT Investigator Group. SAGIT(R): clinician-reported outcome instrument for managing acromegaly in clinical practice--development and results from a pilot study. Pituitary. 2016 Feb;19(1):39-49. doi: 10.1007/s11102-015-0681-2.

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