Clinical trial NCT06350526: Radiological Characterization of Pulmonary Involvement in Patients With Hematological Diseases
Official title: Radiological Characterization of Pulmonary Involvement in Patients With Hematological Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematologic Diseases
Lead sponsor: New Valley University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients aged 18 years or older diagnosed with hematological diseases and documented pulmonary manifestations during their disease course will be included in this retrospective study. Data from their medical records will be analyzed by a team of hematologists, pulmonologists, and radiologists.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients who had certain radiological patterns associated with pulmonary complications in patients diagnosed with various hematological diseases
timeFrame: Once through the study
Secondary outcomes:
measure: Number of patients who developed complications
timeFrame: Once through the study
Other outcomes:
Locations:
city: Asyūţ
country: Egypt
facility: Assiut University Hospital
Study officials:
References:
citation: Messe R, Soccal PM, Bergeron A. [Diagnostic approach to pulmonary complications in patients with hematologic malignancy]. Rev Med Suisse. 2021 Nov 17;17(759):1984-1990. French.
citation: Stecher SS, Lippl S, Stemmler HJ, Schreiber J. [Lung involvement in hematologic systemic diseases]. Internist (Berl). 2018 Sep;59(9):886-897. doi: 10.1007/s00108-018-0471-9. German.
citation: Maschmeyer G, Carratala J, Buchheidt D, Hamprecht A, Heussel CP, Kahl C, Lorenz J, Neumann S, Rieger C, Ruhnke M, Salwender H, Schmidt-Hieber M, Azoulay E. Diagnosis and antimicrobial therapy of lung infiltrates in febrile neutropenic patients (allogeneic SCT excluded): updated guidelines of the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Medical Oncology (DGHO). Ann Oncol. 2015 Jan;26(1):21-33. doi: 10.1093/annonc/mdu192. Epub 2014 May 15.
citation: Periselneris J, Brown JS. A clinical approach to respiratory disease in patients with hematological malignancy, with a focus on respiratory infection. Med Mycol. 2019 Jun 1;57(Supplement_3):S318-S327. doi: 10.1093/mmy/myy138.