Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05694806

Clinical Impact of Thoracic Scanographic Characteristics of Hematologic Malignancy Patients

The mediastinum can be the site of benign or malignant tumors, including 10 to 20% of hematological malignancies.

Mediastinal mass syndrome (MMS) includes symptoms due to irritation, invasion or compression of the organs of the mediastinum. This syndrome includes respiratory manifestations that may be secondary to compression of the tracheobronchial tree, venous vascular manifestations with the superior vena cava syndrome or arterial manifestations, cardiac manifestations, digestive or nervous manifestations.

The management of a mediastinal syndrome is a diagnostic and therapeutic emergency requiring the collaboration of several disciplines in order to achieve the most effective but least deleterious way possible to diagnostic imaging, etiological biopsy, and the possible implementation of life-saving symptomatic measures before the initiation of etiological treatment.

Diagnostic thoracic imaging relies primarily on thoracic computed tomography (CT) to determine the size and nature of the mediastinal mass, the presence and extent of tracheobronchial or great vessel compression, the presence of pleural and/or pericardial effusion, pulmonary embolism, parenchymal lesions, and possibly subdiaphragmatic lesions.

However, the potential severity of MMS is often under-diagnosed in adult patients, particularly in the context of hematologic malignancy. Indeed, we have very little literature on the initial management of these patients at risk.

The present study propose to conduct the first multicenter study to analyze the characteristics (clinical, scanographic, echocardiographic, hematological and resuscitation) of the initial management of patients with symptomatic MMS at diagnosis or at relapse of a patient with MH admitted to the Intensive Care Unit (ICU).

Recruiting

Interested in participating?

Request Info

Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Muriel Picard

Toulouse, France

Location status: Recruiting

Location contact

Muriel Picard, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hematologic malignancy at diagnosis or relapse
  • Symptomatic mediastinal mass syndrome
  • Admission to the ICU, Continuous Medical Surveillance (CMS) or Intensive Care (IC) for symptomatology related to MMS
  • Chest CT (after maximum 48 hours of corticosteroid therapy (1mg/kg/ Prednisone equivalent), maximum 15 days before and 5 days after admission to ICU)
  • Maximum administration of corticosteroid therapy 48 hours before admission to the ICU (maximum 1mg/kg/ Prednisone equivalent)
  • No prior pleural or pericardial drainage
  • Study period: 01/01/2014 - 31/12/2021 (8 years)

Exclusion criteria

  • No diagnosis of hematologic malignancy
  • Diagnosis of solid benign or malignant tumor
  • No mediastinal mass syndrome
  • No admission to ICU/CMS
  • No chest CT scan meeting inclusion criteria
  • Administration of corticosteroids for more than 48 hours prior to admission to the ICU and/or prior to chest CT
  • Lack of social security affiliation.

Treatment and study plan

analysis of thoracic scans

Other

analysis of thoracic scans realised in standard care

Primary outcomes

  1. To identify prognostic thoracic scan factors of severe mediastinal mass syndrome

    Time frame: 1 week

    To identify prognostic thoracic scan factors of severe mediastinal mass syndrome defined by the occurrence of severe respiratory, hemodynamics and/or neurological failures.

Study contacts

Contact information is provided by the study sponsor or research team.

Muriel Picard, MD

CONTACT

[email protected]

0561756105 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Clinical Impact of Thoracic Scanographic Characteristics of Hematologic Malignancy Patients with Mediastinal Mass Syndrome Admitted to the Intensive Care Unit

Acronym: MED-HEM

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 23, 2023
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.