NCT03349372

Brief Summary

Allogeneic hematopoietic stem cell transplantation is the only possible treatment for many malignant and non-malignant hemopathies. The graft-versus-host immunological reaction (GvH) is a frequent and sometimes serious complication. The objective is to study whether a systematic and early follow-up by a lung specialist of allografted patients would allow an earlier diagnosis of GvH with pulmonary complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
227

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

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

November 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
Last Updated

November 21, 2017

Status Verified

November 1, 2017

Enrollment Period

12 months

First QC Date

November 17, 2017

Last Update Submit

November 17, 2017

Conditions

Hematologic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Medical complications

    100 days after allograft

    Medical complications, especially Graft-versus-Host reaction with pulmonary complications occurring within 100 days post-surgery are studied

Interventions

Hematopoietic stem cell transplantationPROCEDURE

Hematopoietic stem cell transplantation

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients from Hospices Civils de Lyon, Lyon, France with blood cancer undergoing a hematopoietic stem cell transplantation between January 2013 and July 2016

You may qualify if:

  • years of age or older
  • patients with a hematopoietic stem cell transplantation

You may not qualify if:

  • Death within 100 days post-surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Croix-Rousse Hospital, Hospices Civils de Lyon

Lyon, 69004, France

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Hematopoietic Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Stem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2017

First Posted

November 21, 2017

Study Start

November 1, 2016

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

November 21, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)