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AzTrials

Cancer PatientsNCT05279378

Correlation of Lung Ultrasonography With Chest CT Findings in Cancer Patients With COVID-19 Viral Pneumonia

An observational study of Cancer Patients, run by South Egypt Cancer Institute at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Thoracic imaging, either with chest X-ray (CXR) or computed tomography (CT), is an essential part of the diagnosis of coronavirus disease-19 (COVID-19) in patients admitted to hospital with fever or respiratory symptoms. Read more about this study

Who is it for?
Ages 16 to 60 years
Conditions the study is for
Cancer Patients
What is being tested?
lung ultrasonography versus CT
How many people
30 participants
Where
1 siteEgypt
Study dates
30 Mar 2022to 28 Nov 2025
How long will I take part?
2 Weeks
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 16 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Cancer patients admitted to South Egypt Cancer Institute (SECI), Asyut University, Egypt with COVID-19 viral pneumonia in the period from March 2022 to December 2023, with ages ranging from 18 to 60 years old, of male or female gender, and CT Chest findings of CORAD 4, 5 and 6 with moderate and severe symptoms.

Who may be able to join

  • The study population will include cancer patients admitted to South Egypt Cancer Institute (SECI), Asyut University, Egypt with COVID-19 viral pneumonia in the period from March 2022 to December 2023, with ages ranging from 18 to 60 years old, of male or female gender, and CT Chest findings of CORAD 4, 5 and 6 with moderate and severe symptoms.
  • All cancer patients are diagnosed COVID-19 by PCR from a nasopharyngeal swab.

Who cannot join

  • Critical conditions need for ICU at the time of admission, presence of severe cardiorespiratory illness other than COVID-19 viral pneumonia, hepatic and renal diseases, coagulopathy, and patient refusal to share in our study will be considered as exclusion criteria.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • South Egypt cancei institute

    Asyut

Other trials in Egypt

About this study

Official title: Correlation of Lung Ultrasonography With Chest CT Findings in Cancer Patients With COVID-19 Viral Pneumonia, an Observational Study

Thoracic imaging, either with chest X-ray (CXR) or computed tomography (CT), is an essential part of the diagnosis of coronavirus disease-19 (COVID-19) in patients admitted to hospital with fever or respiratory symptoms.

Inspite of the results of PCR tests are the gold standard, the sensitivity of CT for diagnosing COVID-19 is 97%. The specific epidemic contingency makes CT an accurate tool to stratify patients based on imaging patterns, predicting poor outcomes and the need for ventilation.

Read more

Lung ultrasound (LUS) is widely used in emergency departments because it is broadly available, low-cost, and has a high accuracy for diagnosing pulmonary diseases.

Despite the diagnostic power of LUS and its influence on decision-making and therapeutic management, there are still significant barriers to the widespread use of this tool.

The advantages of LUS are more obvious in older patients with multimorbidity and restricted mobility, for whom high-quality CXR and CT scans are difficult to obtain. In the hands of experienced clinicians, LUS diagnostic accuracy for bacterial pneumonia is similar to chest CT.

However, a correlation between LUS and CT findings in patient urgently hospitalized for severe COVID-19 pneumonia remains to be determined.

COVID-19 leads to an aggressive inflammatory response that is actually the reaction of the immune system. Some patients exhibit pneumonia in both lungs, multi-organ failure, and even death. Individuals who have severe health conditions, like cancer, cardiovascular diseases, diabetes, and pulmonary diseases, are at higher risk of COVID-19 infection.

Also, this dysregulated immune response resulting in excessive production of inflammatory cytokines and chemokines (as IL-1ra, IL-6, IP-10, G-CSF, MCP-1, MIP-1α and TNF) causes the development of cytokine release syndrome (CRS) which is considered as pathologic underpinning for disease progression and lead to severe collateral tissue damage.

IL-6 may serve as a predictive biomarker for disease severity as its elevated levels were reported in several studies of COVID-19 infection. Also IL-6 levels were correlated with mortality in COVID-19 patients. IL-6 blockade is a promising strategy for COVID-induced CRS.

In particular, clinical epidemiological studies are needed to determine if IL-6 and/or other inflammatory cytokine levels predict subsequent development and persistence of long COVID 19 viral pneumonia.

Conditions
Cancer Patients
Being tested
lung ultrasonography versus CT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lung ultrasonography versus CTRadiation

    chest CT will be done before admission and LUS within first 24 h from admission into the quarantine sector. In addition to 2 weeks after admission.

    CT images will be reviewed by chest radiologist expert, who will calculate a CT severity score based on extension and distribution of GGOs and consolidations.

    All CT scans will be performed in supine position at end inspiration without intravenous administration of contrast media.

    Within 24 h from admission and CT scanning, bedside LUS will be performed by clinician who will be blind to chest CT findings.

    Examinations will be performed with the patient in the sitting position, systematically scanning the front and the back side of each hemithorax.

    Blood sample will be collected into 4 mL Vacuette containing EDTA. Samples will be stored on ice, processed within 30 min and plasma will be isolated by centrifugation at 2000g for 20 min at 4 °C. Plasma will be immediately frozen at - 80 °C in several aliquots.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. comparing the CT versus LUS findings

    comparing the CT versus LUS findings in cancer patients with moderate and severe COVID-19 viral pneumonia who will be admitted to our hospital and to correlate these findings with clinical features

    Measured: 2 weeks

Secondary outcomes (1)
  1. correlation of the results with the level of IL-6

    correlate the results with the clinical data and laboratory data including the level of IL-6, D-dimer, serum ferritin and C-reactive protein (CRP) of those cancer patients during quarantine period.

    Measured: within 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2022
  2. Study start30 Mar 2022
  3. Primary completion30 Jun 2025
  4. Study completion28 Nov 2025

Resources

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
Cohort
Time perspective
Prospective
Enrolment
30 participants (actual)
Target duration
2 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT05279378
Sponsor's protocol ID
IORG0006563
Status last verified
Mar 2022
First submitted
11 Mar 2022
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

    PubMed 32109013
  • Sethuraman N, Jeremiah SS, Ryo A. Interpreting Diagnostic Tests for SARS-CoV-2. JAMA. 2020 Jun 9;323(22):2249-2251. doi: 10.1001/jama.2020.8259. No abstract available.

    PubMed 32374370
  • Kim H, Hong H, Yoon SH. Diagnostic Performance of CT and Reverse Transcriptase Polymerase Chain Reaction for Coronavirus Disease 2019: A Meta-Analysis. Radiology. 2020 Sep;296(3):E145-E155. doi: 10.1148/radiol.2020201343. Epub 2020 Apr 17.

    PubMed 32301646
  • Ai T, Yang Z, Hou H, Zhan C, Chen C, Lv W, Tao Q, Sun Z, Xia L. Correlation of Chest CT and RT-PCR Testing for Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases. Radiology. 2020 Aug;296(2):E32-E40. doi: 10.1148/radiol.2020200642. Epub 2020 Feb 26.

    PubMed 32101510
  • Colombi D, Bodini FC, Petrini M, Maffi G, Morelli N, Milanese G, Silva M, Sverzellati N, Michieletti E. Well-aerated Lung on Admitting Chest CT to Predict Adverse Outcome in COVID-19 Pneumonia. Radiology. 2020 Aug;296(2):E86-E96. doi: 10.1148/radiol.2020201433. Epub 2020 Apr 17.

    PubMed 32301647
  • Kwee TC, Kwee RM. Chest CT in COVID-19: What the Radiologist Needs to Know. Radiographics. 2020 Nov-Dec;40(7):1848-1865. doi: 10.1148/rg.2020200159. Epub 2020 Oct 23.

    PubMed 33095680
  • Gargani L, Picano E. The risk of cumulative radiation exposure in chest imaging and the advantage of bedside ultrasound. Crit Ultrasound J. 2015 Mar 28;7:4. doi: 10.1186/s13089-015-0020-x. eCollection 2015.

    PubMed 25883779
  • Mossa-Basha M, Meltzer CC, Kim DC, Tuite MJ, Kolli KP, Tan BS. Radiology Department Preparedness for COVID-19: Radiology Scientific Expert Review Panel. Radiology. 2020 Aug;296(2):E106-E112. doi: 10.1148/radiol.2020200988. Epub 2020 Mar 16. No abstract available.

    PubMed 32175814
  • de Alencar JCG, Marchini JFM, Marino LO, da Costa Ribeiro SC, Bueno CG, da Cunha VP, Lazar Neto F, Brandao Neto RA, Souza HP; COVID U. S. P. Registry Team. Lung ultrasound score predicts outcomes in COVID-19 patients admitted to the emergency department. Ann Intensive Care. 2021 Jan 11;11(1):6. doi: 10.1186/s13613-020-00799-w.

    PubMed 33427998
  • Georgopoulos D, Xirouchaki N, Volpicelli G. Lung ultrasound in the intensive care unit: let's move forward. Intensive Care Med. 2014 Oct;40(10):1592-4. doi: 10.1007/s00134-014-3484-4. Epub 2014 Sep 18. No abstract available.

    PubMed 25231292
  • Nouvenne A, Zani MD, Milanese G, Parise A, Baciarello M, Bignami EG, Odone A, Sverzellati N, Meschi T, Ticinesi A. Lung Ultrasound in COVID-19 Pneumonia: Correlations with Chest CT on Hospital admission. Respiration. 2020;99(7):617-624. doi: 10.1159/000509223. Epub 2020 Jun 22.

    PubMed 32570265
  • Ticinesi A, Scarlata S, Nouvenne A, Lauretani F, Incalzi RA, Ungar A; GRETA (Gruppo di Ricerca sull'Ecografia Toracica nell'Anziano) Group of the Italian Society of Gerontology and Geriatrics (SIGG). The Geriatric Patient: The Ideal One for Chest Ultrasonography? A Review From the Chest Ultrasound in the Elderly Study Group (GRETA) of the Italian Society of Gerontology and Geriatrics (SIGG). J Am Med Dir Assoc. 2020 Apr;21(4):447-454.e6. doi: 10.1016/j.jamda.2019.06.018. Epub 2019 Aug 6.

    PubMed 31399360
  • Berlet T. Thoracic ultrasound for the diagnosis of pneumonia in adults: a meta-analysis. Respir Res. 2015 Jul 25;16(1):89. doi: 10.1186/s12931-015-0248-9. No abstract available.

    PubMed 26205975
  • Fu Y, Cheng Y, Wu Y. Understanding SARS-CoV-2-Mediated Inflammatory Responses: From Mechanisms to Potential Therapeutic Tools. Virol Sin. 2020 Jun;35(3):266-271. doi: 10.1007/s12250-020-00207-4. Epub 2020 Mar 3.

    PubMed 32125642
  • Liu F, Zhang Q, Huang C, Shi C, Wang L, Shi N, Fang C, Shan F, Mei X, Shi J, Song F, Yang Z, Ding Z, Su X, Lu H, Zhu T, Zhang Z, Shi L, Shi Y. CT quantification of pneumonia lesions in early days predicts progression to severe illness in a cohort of COVID-19 patients. Theranostics. 2020 Apr 27;10(12):5613-5622. doi: 10.7150/thno.45985. eCollection 2020.

    PubMed 32373235

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer Patients, run by South Egypt Cancer Institute 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 2 inclusion and 1 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 18 Feb 2026. 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?

comparing the CT versus LUS findings (time frame: 2 weeks). 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 NCT05279378, which also lists 24 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 18 Feb 2026.

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