- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05290441
Evaluation of Postmortem Pulmonary Interstitial Fibrosis Severity and EGFR Positivity in Covid-19 Pneumonia
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
The pathophysiology of Covid 19 infection still remains complex. Diffuse alveolo-interstitial damage, organizing pneumonia and severe fibrotic organizing pneumonia have been reported and possibly associated with cytokine storm. However, profibrotic pathways and mediators involved in fibrosis and the severity of fibrosis may differ individually. Epidermal growth factor (EGF) is a protein-structured growth factor that stimulates cell division, differentiation, survival, proliferation, growth and cell migration. It acts through the epidermal growth factor receptor (EGFR). The stimulating effect of fibroblasts, kerotinocytes, and vascular endothelial cells is known to stimulate growth and proliferation, and plays a role in the repair process of the lungs and the development of pulmonary fibrosis. EGFR is also a tyrosine kinase receptor. The relationship between fibrosis severity and EGFR positivity in the tissues of deceased covid pneumonia patients, demographic data of the patients, their combinations and the treatment they receive may guide treatment approaches.
The aim of this study is to examine the relationship between the severity of fibrosis in the lung tissue and EGFR positivity in patients who died due to covid-19 pneumonia, demographic characteristics, comorbidities, biochemistry values, and treatments they receive.
Material methods: Transthoracic tru-cut biopsy will be performed with the permission of their families, for patients hospitalized in the intensive care unit of our hospital and who died due to Covid 19 pneumonia. Biopsy, where the involvement is more intense compared hemithorax to the radiological appearance, will be performed blindly. By studying EGFR on biopsy materials, fibrosis grade will be classified as 0=none; 1=mild; 2=medium; 3=severe. Thoracic CT images of the patients were reviewed by a radiologist, and the fibrosis image and extent will again be classified as 0=none; 1=mild; 2=medium; 3=severe. Medications used, additional diseases, demographic data, length of stay in the intensive care unit, and intubation times will be recorded. The relationship between EGFR positivity and other data will be analyzed statistically.
The relationship between fibrosis severity and EGFR positivity in the tissues of deceased covid pneumonia patients, demographic data of the patients, their combinations and the treatment they receive may guide treatment approaches. It may shed light on the fact that fibrolytic drugs, which act as tyrosine kinase inhibitors and are used in idiopathic interstitial fibrosis, can also be used in covid 19 pneumonia damage.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Seyhan U Dülger
- Telefonnummer: +905057482841
- E-mail: drsdulger@gmail.com
Studiesteder
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Eyalet/Yerleşke
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Bursa, Eyalet/Yerleşke, Kalkun, 16115
- Rekruttering
- Bursa yüksek ihtisas EAH
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Kontakt:
- Seyhan Dülger
- Telefonnummer: +905057482841
- E-mail: drsdulger@gmail.com
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Yıldırım
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Bursa, Yıldırım, Kalkun, 16115
- Rekruttering
- Seyhan Dülger
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Kontakt:
- Seyhan Dülger
- Telefonnummer: 05057482841
- E-mail: drsdulger@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- > 18 years old
- Patients who died while lying in the Intensive Care Unit with the diagnosis of Covid-19 pneumonia
Exclusion Criteria:
- <18 years old
- Patients who were treated with the diagnosis of Covid 19 pneumonia and recovered
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: None involement
In the pathological examination, the group of patients without EGFR involvement in the biopsy material.
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No EGFR involvement
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Aktiv komparator: Mild
In the pathological examination, the group of patients mild EGFR involvement in the biopsy material.
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No EGFR involvement
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Aktiv komparator: Moderate
In the pathological examination, the group of patients moderate EGFR involvement in the biopsy material.
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No EGFR involvement
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Aktiv komparator: Severe
In the pathological examination, the group of patients severe EGFR involvement in the biopsy material
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No EGFR involvement
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Fibrosis
Tidsramme: "through study completion, an average of 1 year".
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EGFR involvement
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"through study completion, an average of 1 year".
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- Liu X, Wang P, Zhang C, Ma Z. Epidermal growth factor receptor (EGFR): A rising star in the era of precision medicine of lung cancer. Oncotarget. 2017 Jul 25;8(30):50209-50220. doi: 10.18632/oncotarget.16854.
- George PM, Wells AU, Jenkins RG. Pulmonary fibrosis and COVID-19: the potential role for antifibrotic therapy. Lancet Respir Med. 2020 Aug;8(8):807-815. doi: 10.1016/S2213-2600(20)30225-3. Epub 2020 May 15.
- Dulger SU, Mutlu N, Ceylan I, Ozhan E. The relationship between lung fibrosis, the epidermal growth factor receptor, and disease outcomes in COVID-19 pneumonia: a postmortem evaluation. Clin Exp Med. 2022 Aug 20:1-8. doi: 10.1007/s10238-022-00872-7. Online ahead of print.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2011-KAEK-25 2021/08-10
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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