NCT01791166

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

September 12, 2016

Status Verified

September 1, 2016

Enrollment Period

2.7 years

First QC Date

February 12, 2013

Last Update Submit

September 9, 2016

Conditions

Lung Transplant

Outcome Measures

Primary Outcomes (1)

  • Incidence of immune Markers of acute lung transplant rejection (Anti-HLA circulatory antibodies, neutrophils and C4d immune markers.

    12 months after pulmonary transplant

Study Arms (1)

Pulmonary transplant

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

Interventions

Blood test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX testsBIOLOGICAL
Pulmonary transplant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital FOCH

Suresnes, Île-de-France Region, 92150, France

Location

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2013

First Posted

February 13, 2013

Study Start

February 1, 2011

Primary Completion

October 1, 2013

Study Completion

July 1, 2014

Last Updated

September 12, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)