Hematologic DiseasesNCT06350526
Radiological Characterization of Pulmonary Involvement in Patients With Hematological Diseases
An observational study of Hematologic Diseases, run by New Valley University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Diseases
- What is being tested?
- Complete Blood Count, C-reactive protein and O2 saturation
- Type of treatment
- Surgery or procedure
- How many people
- 148 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Sep 2024to 21 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients aged 18 years or older diagnosed with hematological diseases and documented pulmonary manifestations during their disease course
Who cannot join
- Patients aged under 18 years.
- Patients without demonstrable evidence of lung involvement.
- Patients with incomplete medical records or insufficient data to analyze.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Hematologic Diseases
- Being tested
- Complete Blood Count, C-reactive protein, O2 saturation, Serum ferritin and D-dimer, Liver and renal function tests
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete Blood CountDiagnostic test
blood sample
C-reactive proteinDiagnostic test
serum sample
O2 saturationDiagnostic test
blood sample
Serum ferritin and D-dimerDiagnostic test
Blood sample
Liver and renal function testsDiagnostic test
Blood sample
Lactate dehydrogenaseDiagnostic test
Blood sample
coronavirus (SARS-CoV-2) swabDiagnostic test
Throat swab
CT chestRadiation
Radiation
| Study group | Role | What they receive |
|---|---|---|
| 1 | patient admitted with hematological disease and pulmonary manifestations Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who had certain radiological patterns associated with pulmonary complications in patients diagnosed with various hematological diseases
Measured: Once through the study
Secondary outcomes (1)
Number of patients who developed complications
Measured: Once through the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start27 Sep 2024
- Primary completion1 Aug 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hematologic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Nady Hussein, New Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350526
- Sponsor's protocol ID
- PULMHEMA
- Status last verified
- Nov 2025
- First submitted
- 1 Feb 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 34787973Stecher 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.
PubMed 30046891Maschmeyer 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.
PubMed 24833776Periselneris 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.
PubMed 31292655
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological Characterization of Pulmonary Involvement in Patients With Hematological Diseases
- ClinicalTrials.gov ID
- NCT06350526
- Acronym / sponsor ID
- PULMHEMA
- Conditions
- Hematologic Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- New Valley UniversityUniversity, hospital or other
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | 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 chestpatient admitted with hematological disease and pulmonary manifestations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients aged 18 years or older diagnosed with hematological diseases and documented pulmonary manifestations during their disease course
Key exclusion criteria (3 listed)
- Patients aged under 18 years.
- Patients without demonstrable evidence of lung involvement.
- Patients with incomplete medical records or insufficient data to analyze.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete Blood Countblood sample | Diagnostic test | 1 |
| C-reactive proteinserum sample | Diagnostic test | 1 |
| O2 saturationblood sample | Diagnostic test | 1 |
| Serum ferritin and D-dimerBlood sample | Diagnostic test | 1 |
| Liver and renal function testsBlood sample | Diagnostic test | 1 |
| Lactate dehydrogenaseBlood sample | Diagnostic test | 1 |
| coronavirus (SARS-CoV-2) swabThroat swab | Diagnostic test | 1 |
| CT chestRadiation | Radiation | 1 |
Primary outcome
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
1 secondary outcome
Number of patients who developed complications
Time frame: Once through the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Background: PubMed 34787973Messe 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.
- Background: PubMed 30046891Stecher 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.
- Background: PubMed 24833776Maschmeyer 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.
- Background: PubMed 31292655Periselneris 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Diseases, run by New Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06350526, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.