Clinical Impact of Thoracic Scanographic Characteristics of Hematologic Malignancy Patients (MED-HEM)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Mediastinal Diseases
• Intervention / Treatment: Other: analysis of thoracic scans

• Study Type: Observational
• Enrollment (Estimated): 125

Contacts and Locations

• Study Contact: Name: Muriel Picard, MD; Phone Number: +33 0561756105; Email: picard.m@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France
    • Recruiting
    • Muriel Picard
    • Contact: Muriel Picard, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients with eligibility criteria hospitalised during the study period 01/01/2014 - 31/12/2021

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with symptomatic Mediastinal mass syndrome; patients with symptomatic Mediastinal mass syndrome at diagnosis or at relapse of a patient with haematological malignancy admitted to the Intensive Care unit	Other: analysis of thoracic scans; analysis of thoracic scans realised in standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To identify prognostic thoracic scan factors of severe mediastinal mass syndrome	To identify prognostic thoracic scan factors of severe mediastinal mass syndrome defined by the occurrence of severe respiratory, hemodynamics and/or neurological failures.	1 week

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Muriel Picard, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Mediastinal mass syndrome
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Hematologic Diseases; Thoracic Diseases; Hematologic Neoplasms; Mediastinal Diseases
• Other Study ID Numbers: RC31/22/0237

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No