- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05279378
Correlation of Lung Ultrasonography With Chest CT Findings in Cancer Patients With COVID-19 Viral Pneumonia
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Salma ZT SECI, Ass lecturer
- Phone Number: 0201069572290
- Email: Salmazanaty91@gmail.com
Study Locations
-
-
-
Assiut, Egypt
- Recruiting
- South Egypt cancei institute
-
Contact:
- salma ZT SECI, Ass.lecturer
- Phone Number: 0201069572290
- Email: Salmazanaty91@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
comparing the CT versus LUS findings
Time Frame: 2 weeks
|
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
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
correlation of the results with the level of IL-6
Time Frame: within 2 weeks
|
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.
|
within 2 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
- Dai M, Liu D, Liu M, Zhou F, Li G, Chen Z, Zhang Z, You H, Wu M, Zheng Q, Xiong Y, Xiong H, Wang C, Chen C, Xiong F, Zhang Y, Peng Y, Ge S, Zhen B, Yu T, Wang L, Wang H, Liu Y, Chen Y, Mei J, Gao X, Li Z, Gan L, He C, Li Z, Shi Y, Qi Y, Yang J, Tenen DG, Chai L, Mucci LA, Santillana M, Cai H. Patients with Cancer Appear More Vulnerable to SARS-CoV-2: A Multicenter Study during the COVID-19 Outbreak. Cancer Discov. 2020 Jun;10(6):783-791. doi: 10.1158/2159-8290.CD-20-0422. Epub 2020 Apr 28.
- 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.
- 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.
- 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.
- 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. Erratum In: Radiographics. 2022 Jan-Feb;42(1):E32.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Respir Res. 2015;16:104.
- 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.
- 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.
- Nishiga M, Wang DW, Han Y, Lewis DB, Wu JC. COVID-19 and cardiovascular disease: from basic mechanisms to clinical perspectives. Nat Rev Cardiol. 2020 Sep;17(9):543-558. doi: 10.1038/s41569-020-0413-9. Epub 2020 Jul 20.
- Yue H, Bai X, Wang J, Yu Q, Liu W, Pu J, Wang X, Hu J, Xu D, Li X, Kang N, Li L, Lu W, Feng T, Ding L, Li X, Qi X; Gansu Provincial Medical Treatment Expert Group of COVID-19. Clinical characteristics of coronavirus disease 2019 in Gansu province, China. Ann Palliat Med. 2020 Jul;9(4):1404-1412. doi: 10.21037/apm-20-887. Epub 2020 Jul 13.
- Parsons PE, Eisner MD, Thompson BT, Matthay MA, Ancukiewicz M, Bernard GR, Wheeler AP; NHLBI Acute Respiratory Distress Syndrome Clinical Trials Network. Lower tidal volume ventilation and plasma cytokine markers of inflammation in patients with acute lung injury. Crit Care Med. 2005 Jan;33(1):1-6; discussion 230-2. doi: 10.1097/01.ccm.0000149854.61192.dc.
- Giamarellos-Bourboulis EJ, Netea MG, Rovina N, Akinosoglou K, Antoniadou A, Antonakos N, Damoraki G, Gkavogianni T, Adami ME, Katsaounou P, Ntaganou M, Kyriakopoulou M, Dimopoulos G, Koutsodimitropoulos I, Velissaris D, Koufargyris P, Karageorgos A, Katrini K, Lekakis V, Lupse M, Kotsaki A, Renieris G, Theodoulou D, Panou V, Koukaki E, Koulouris N, Gogos C, Koutsoukou A. Complex Immune Dysregulation in COVID-19 Patients with Severe Respiratory Failure. Cell Host Microbe. 2020 Jun 10;27(6):992-1000.e3. doi: 10.1016/j.chom.2020.04.009. Epub 2020 Apr 21.
- Patrucco F, Albera C, Bellocchia M, Foci V, Gavelli F, Castello LM, Bellan M, Sainaghi PP, Airoldi C, Balbo PE, Solidoro P. SARS-CoV-2 Detection on Bronchoalveolar Lavage: An Italian Multicenter experience. Respiration. 2020;99(11):970-978. doi: 10.1159/000511964. Epub 2020 Oct 19.
- Wasilewski PG, Mruk B, Mazur S, Poltorak-Szymczak G, Sklinda K, Walecki J. COVID-19 severity scoring systems in radiological imaging - a review. Pol J Radiol. 2020 Jul 17;85:e361-e368. doi: 10.5114/pjr.2020.98009. eCollection 2020.
- Falster C, Jacobsen N, Wulff Madsen L, Dahlerup Rasmussen L, Davidsen JR, Christie Knudtzen F, Nielsen SL, Johansen IS, Laursen CB. Lung ultrasound may be a valuable aid in decision making for patients admitted with COVID-19 disease. Eur Clin Respir J. 2021 Apr 7;8(1):1909521. doi: 10.1080/20018525.2021.1909521.
- Soldati G, Smargiassi A, Inchingolo R, Buonsenso D, Perrone T, Briganti DF, Perlini S, Torri E, Mariani A, Mossolani EE, Tursi F, Mento F, Demi L. Proposal for International Standardization of the Use of Lung Ultrasound for Patients With COVID-19: A Simple, Quantitative, Reproducible Method. J Ultrasound Med. 2020 Jul;39(7):1413-1419. doi: 10.1002/jum.15285. Epub 2020 Apr 13.
Helpful Links
- Interpreting Diagnostic Tests for SARS-CoV-2
- Diagnostic Performance of CT and Reverse Transcriptase Polymerase Chain Reaction for Coronavirus Disease 2019: A Meta-Analysis
- Correlation of Chest CT and RT-PCR Testing for Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases
- Well-aerated Lung on Admitting Chest CT to Predict Adverse Outcome in COVID-19 Pneumonia.
- The risk of cumulative radiation exposure in chest imaging and the advantage of bedside ultrasound
- The risk of cumulative radiation exposure in chest imaging and the advantage of bedside ultrasound
- Lung ultrasound score predicts outcomes in COVID-19 patients admitted to the emergency department
- Lung ultrasound in the intensive care unit: let's move forward
- Lung Ultrasound in COVID-19 Pneumonia: Correlations with Chest CT on Hospital admission
- 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)
- Thoracic ultrasound for the diagnosis of pneumonia in adults: A meta-analysis
- Understanding SARS-CoV-2-Mediated Inflammatory Responses: From Mechanisms to Potential Therapeutic Tools
- CT quantification of pneumonia lesions in early days predicts progression to severe illness in a cohort of COVID-19 patients
- COVID-19 and cardiovascular disease: from basic mechanisms to clinical perspectives
- Related Info
- Patients with Cancer Appear More Vulnerable to SARS-CoV-2: A Multicenter Study during the COVID-19 Outbreak
- Clinical characteristics of coronavirus disease 2019 in Gansu province
- Lung ultrasound score predicts outcomes in COVID-19 patients admitted to the emergency department.
- Lung ultrasound in the intensive care unit: let's move forward
- Lung Ultrasound in COVID-19 Pneumonia: Correlations with Chest CT on Hospital admission
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
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
Other Study ID Numbers
- IORG0006563
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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