Clustering Among the Clinical Profiles of Patients With P... | NCT03086499

Studies
Clustering Among the Clinical Profiles of Patients With Pectus Excavatum

NCT03086499

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Apr 10, 2017Actual

Enrollment

55Actual

Phase

Not provided

Conditions

Funnel Chest

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

Mar 2017

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

Mar 25, 2017Actual

Primary Completion Date

Mar 30, 2017Actual

Completion Date

Mar 30, 2017Actual

First Submitted Date

Mar 16, 2017

First Submission Date that Met QC Criteria

Mar 16, 2017

First Posted Date

Mar 22, 2017Actual

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 6, 2017

Last Update Posted Date

Apr 10, 2017Actual

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 primary objective of this study is to describe the relative distances between patient clinical profiles (i.e. patient clustering) in multivariate space.

Detailed Description

Observational data will be collected from patient files and submitted to clustering analyses. Then clusters will be compared.

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

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
The study population		Patients with pectus excavatum having consulted at the Montpellier University Hospital and who have had corrective surgery.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of clusters found	The number of clusters found among clinical profiles	Day 0 (transversal, retrospective study)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patient with pectus excavatum
The patient has had corrective surgery

Exclusion Criteria:

The patient has expressed opposition to the study

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

Patients with pectus excavatum having consulted at the Montpellier University Hospital and who have had corrective surgery.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean Philippe Berthet, MD, PhD	University Hospital, Montpellier	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire de Montpellier		Montpellier		34295	France

Label	URL
PECTUS-cluster on the Open Science Framework	View source

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
D005660	Funnel Chest

Ancestor Terms

ID	Term
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D009139	Musculoskeletal Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided