Immuno-humoral Rejection Markers in Pulmonary Transplant | NCT01791166

Studies
Immuno-humoral Rejection Markers in Pulmonary Transplant

NCT01791166

Sponsor

Hopital Foch

Status

Completed

Last Update Posted

Sep 12, 2016Estimated

Enrollment

53Actual

Phase

Not Applicable

Conditions

Lung Transplant

Interventions

Blood test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX tests

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

Sep 2016

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 2011

Primary Completion Date

Oct 2013Actual

Completion Date

Jul 2014Actual

First Submitted Date

Feb 12, 2013

First Submission Date that Met QC Criteria

Feb 12, 2013

First Posted Date

Feb 13, 2013Estimated

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

Sep 9, 2016

Last Update Posted Date

Sep 12, 2016Estimated

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

Open multicentric prospective study performed on pulmonary transplanted patients to detect the values of different diagnostic markers for immuno- humoral reaction and their roles in the humoral rejection for those patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pulmonary transplant	Experimental		Biological: Blood test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX tests

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX tests	Biological		Pulmonary transplant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of immune Markers of acute lung transplant rejection (Anti-HLA circulatory antibodies, neutrophils and C4d immune markers.		12 months after pulmonary transplant

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Both genders, more than 18 years of age.
Patients with or without Cystic fibrosis
Patients with no previous unilateral or bilateral pulmonary transplant or cardiopulmonary transplant
Patients with no current other disease can affect, in short term, the process or prognosis of the transplant
Patients had given his agreement to be enrolled in the study

Exclusion Criteria:

Patient less than 18 year-old
Patient had previous organ transplant
Pregnant and/or lactating women
Female subject in reproductive age does not use effective contraceptive methode
Alcoholisms or neuropsychosis, conditions that affect the good comprehension of 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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital FOCH		Suresnes	Île-de-France Region	92150	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006403	Hematologic Tests

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided