NCT02897882

Brief Summary

The objective of this project is to estimate the frequency and the characters of the chronic pains by a follow-up which begins during the registration on the waiting list of transplant and which ends at the end of the third year following the lung transplantation. It is a forward-looking study of prevalence entering within the framework of the common care. After lung transplant, pain will be evaluate with questionnaires every day during the hospitalisation, and then after 1 month, 3 months, 6 months, 1 year, 2 years and 3 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable pain

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

May 1, 2010

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2017

Completed
Last Updated

May 22, 2017

Status Verified

May 1, 2017

Enrollment Period

7 years

First QC Date

August 31, 2016

Last Update Submit

May 19, 2017

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Chronic pain measured by a digital scale

    3 years

Study Arms (1)

Lung transplant

EXPERIMENTAL

Pain evaluation

Other: Lung transplant

Interventions

Lung transplantOTHER

Pain evaluation

Lung transplant

Eligibility Criteria

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

You may qualify if:

  • Patients benefiting from a lung transplant
  • Patients on a list for a lung transplant from may 2010

You may not qualify if:

  • Patients refusing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Pain

Interventions

Lung Transplantation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pulmonary Surgical ProceduresThoracic Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantation

Study Officials

  • Marc Fischler, PhD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 13, 2016

Study Start

May 1, 2010

Primary Completion

April 27, 2017

Study Completion

April 27, 2017

Last Updated

May 22, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)