Clinical Impact of Thoracic Scanographic Characteristics of Hematologic Malignancy Patients

NCT05694806 | Recruiting

• 1 other identifier: RC31/22/0237
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Mediastinal Diseases

Keywords

Mediastinal mass syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

analysis of thoracic scans OTHER

analysis of thoracic scans realised in standard care

patients with symptomatic Mediastinal mass syndrome

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• No diagnosis of hematologic malignancy
• Diagnosis of solid benign or malignant tumor
• No mediastinal mass syndrome
• No admission to ICU/CMS
• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Muriel Picard

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Mediastinal Diseases

Condition Hierarchy (Ancestors)

Thoracic Diseases; Respiratory Tract Diseases

Study Officials

• Muriel Picard, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muriel Picard, MD

CONTACT

0561756105; picard.m@chu-toulouse.fr

Study Design

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

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 23, 2023
• Study Start: June 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)