Radiological Characterization of Pulmonary Involvement in Patients With Hematological Diseases

Recruiting

• Conditions: Hematologic Diseases
• Interventions: Diagnostic Test: Complete Blood Count; Diagnostic Test: C-reactive protein; Diagnostic Test: O2 saturation; Diagnostic Test: Serum ferritin and D-dimer; Diagnostic Test: Liver and renal function tests; Diagnostic Test: Lactate dehydrogenase; Diagnostic Test: coronavirus (SARS-CoV-2) swab; Radiation: CT chest

• Registration Number: NCT06350526
• Lead Sponsor: New Valley University

Brief Summary

Hematologic malignancies are heterogeneous groups of neoplasia, with frequent pulmonary complications. These complications may be secondary to the patient's comorbidities, to the hemopathy itself, or its treatments. Divided into infectious and non-infectious complications, the etiologies are numerous and varied. This makes the diagnostic approach complex for the clinicians

Detailed Description

Although infectious processes of the lungs are common in these immunosuppressed patient collectives, non-infectious causes account for up to half of the pulmonary manifestations found in hematologic malignancies. Besides the frequent infections including opportunistic pathogens, a broad differential diagnosis including drug-induced lung injury by cytostatic substances, cytokines, and innovative immunotherapeutic agents, rarer transfusion of blood products, and intrathoracic manifestations of the hematologic malignancy itself, must be kept in mind. Finally, vascular complications can also lead to pulmonary reactions. Early and consistent diagnostics and treatment of bronchopulmonary, intrathoracic, and vascular complications within the framework of hematologic systemic diseases can be essential for the patient's prognosis. Up to 25% of patients with profound neutropenia lasting for \>10 days develop lung infiltrates, which frequently do not respond to broad-spectrum antibacterial therapy. While a causative pathogen remains undetected in most cases, Aspergillus spp., Pneumocystis jirovecii, multi-resistant Gram-negative pathogens, mycobacteria or respiratory viruses may be involved. In at-risk patients who have received trimethoprim-sulfamethoxazole (TMP/SMX) prophylaxis, filamentous fungal pathogens appear to be predominant, yet commonly not proven at the time of treatment initiation.

In patients who do not improve rapidly with first-line therapy with broad spectrum antibiotics, cross-sectional thoracic CT imaging is essential. It provides much better definition of the pattern of radiological changes that includes three main groups: consolidation, nodules (micro- and macro-), and diffuse changes, as ground glass pattern. Discuss these radiological patterns and how this guides the appropriate initial investigations and treatment options will be of a great value to be followed.

Study Timeline

• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-04-01
• Study First Posted: 2024-04-05
• Status Verified: 2024-09
• Study Start: 2024-09-27
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30
• Primary Completion: 2025-03-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• All patients aged 18 years or older diagnosed with hematological diseases and documented pulmonary manifestations during their disease course

Exclusion Criteria

1. Patients aged under 18 years.
2. Patients without demonstrable evidence of lung involvement.
3. Patients with incomplete medical records or insufficient data to analyze.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	C-reactive protein	patient admitted with hematological disease and pulmonary manifestations
1	Serum ferritin and D-dimer	patient admitted with hematological disease and pulmonary manifestations
1	Complete Blood Count	patient admitted with hematological disease and pulmonary manifestations
1	O2 saturation	patient admitted with hematological disease and pulmonary manifestations
1	Liver and renal function tests	patient admitted with hematological disease and pulmonary manifestations
1	Lactate dehydrogenase	patient admitted with hematological disease and pulmonary manifestations
1	coronavirus (SARS-CoV-2) swab	patient admitted with hematological disease and pulmonary manifestations
1	CT chest	patient admitted with hematological disease and pulmonary manifestations

Primary Outcome Measures

Name	Time	Method
Number of patients who had certain radiological patterns associated with pulmonary complications in patients diagnosed with various hematological diseases	Once through the study

Secondary Outcome Measures

Name	Time	Method
Number of patients who developed complications	Once through the study

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Asyūţ, Egypt