Radiological Characterization of Pulmonary Involvement in Patients With Hematological Diseases

Hematologic Diseases Clinical Trial

Official title:

Radiological Characterization of Pulmonary Involvement in Patients With Hematological Diseases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06350526
• Other study ID #: PULMHEMA
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: New Valley University
• Contact: Asmaa N Hussein, MD
• Phone: 01065161752
• Email: asmaanady_1010[@]med.nvu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Diseases

Intervention

Diagnostic Test:
• Complete Blood Count
blood sample
• C-reactive protein
serum sample
• O2 saturation
blood sample
• Serum ferritin and D-dimer
Blood sample
• Liver and renal function tests
Blood sample
• Lactate dehydrogenase
Blood sample
• coronavirus (SARS-CoV-2) swab
Throat swab

Radiation:
• CT chest
Radiation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New Valley University

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who had certain radiological patterns associated with pulmonary complications in patients diagnosed with various hematological diseases		Once through the study
Secondary	Number of patients who developed complications		Once through the study