- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06350526
Radiological Characterization of Pulmonary Involvement in Patients With Hematological Diseases
Study Overview
Status
Conditions
Intervention / Treatment
- 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
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Asyut, Egypt
- Assiut University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients aged 18 years or older diagnosed with hematological diseases and documented pulmonary manifestations during their disease course
Exclusion Criteria:
- Patients aged under 18 years.
- Patients without demonstrable evidence of lung involvement.
- Patients with incomplete medical records or insufficient data to analyze.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
patient admitted with hematological disease and pulmonary manifestations
|
blood sample
serum sample
blood sample
Blood sample
Blood sample
Blood sample
Throat swab
Radiation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of patients who had certain radiological patterns associated with pulmonary complications in patients diagnosed with various hematological diseases
Time Frame: Once through the study
|
Once through the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of patients who developed complications
Time Frame: Once through the study
|
Once through the study
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Hemic and Lymphatic Diseases
- Hematologic Diseases
- Investigative Techniques
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Cell Count
- Cytological Techniques
- Hematologic Tests
- Cell Physiological Phenomena
- Blood Physiological Phenomena
- Circulatory and Respiratory Physiological Phenomena
- Diagnostic Techniques, Urological
- Blood Cell Count
- Kidney Function Tests
Other Study ID Numbers
- PULMHEMA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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