NCT04141735

Brief Summary

We would like conduct a real-life study in our center to evaluate the early detection of sinusoidal obstruction syndrome with hepatic ultrasound or elastography before allogeneic hematopoietic stem cell transplantation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

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

September 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

October 25, 2019

Last Update Submit

September 23, 2025

Conditions

Keywords

SOS

Outcome Measures

Primary Outcomes (1)

  • incidence in the cohort of sinusoidal obstruction syndrome

    incidence

    up to 24 months

Study Arms (1)

patients from September 2016 to September 2018

all patients underwent allogeneic hematopoietic stem cell transplantation

Diagnostic Test: ultrasound

Interventions

ultrasoundDIAGNOSTIC_TEST

no intervention

patients from September 2016 to September 2018

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients transplanted for hematologic disease

You may qualify if:

  • all adult patients with allogeneic hematopoietic stem cell transplantation in Nancy University Hospital between Sep 2016 and dec 2024

You may not qualify if:

  • age \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Mohty M, Malard F, Abecassis M, Aerts E, Alaskar AS, Aljurf M, Arat M, Bader P, Baron F, Bazarbachi A, Blaise D, Ciceri F, Corbacioglu S, Dalle JH, Dignan F, Fukuda T, Huynh A, Masszi T, Michallet M, Nagler A, NiChonghaile M, Okamoto S, Pagliuca A, Peters C, Petersen FB, Richardson PG, Ruutu T, Savani BN, Wallhult E, Yakoub-Agha I, Duarte RF, Carreras E. Revised diagnosis and severity criteria for sinusoidal obstruction syndrome/veno-occlusive disease in adult patients: a new classification from the European Society for Blood and Marrow Transplantation. Bone Marrow Transplant. 2016 Jul;51(7):906-12. doi: 10.1038/bmt.2016.130. Epub 2016 May 16.

    PMID: 27183098BACKGROUND
  • Lassau N, Auperin A, Leclere J, Bennaceur A, Valteau-Couanet D, Hartmann O. Prognostic value of doppler-ultrasonography in hepatic veno-occlusive disease. Transplantation. 2002 Jul 15;74(1):60-6. doi: 10.1097/00007890-200207150-00011.

    PMID: 12134100BACKGROUND

MeSH Terms

Conditions

Hepatic Veno-Occlusive Disease

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Maud D'Aveni, MD, PhD

    Université de Lorraine - CHRU de Nancy

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 25, 2019

First Posted

October 28, 2019

Study Start

September 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

September 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share