- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02758678
Analysis of P-Selectin Expression on Platelets of Blood From Lung Cancer Patients
Analysis of P-selectin Expression on Platelets of Blood Between Serum Samples From Lung Cancer and Healthy Individuals by Using Raman Spectroscopy
Purpose:
Selectins are vascular cell adhesion molecules involved in adhesive interactions of leukocytes and platelets and endothelium within the blood circulation.
Plasma soluble P selectin (sP-selectin), is a one of member of selectin family, an adhesion molecule and component of the membrane of the platelet alpha granulate has been proposed as a one marker of platelet activation. In this study we evaluate of expression of P selectin on platelets of blood between serum samples from lung cancer and healthy individuals.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Material and Methods:
The investigators enrolled patients with lung cancer which divided on 3 group: 1- 23 patients with operating tumor; 2-ten patients with advanced and metastatic disease who received palliative RT (RT - radiotherapy); 3-five patients with advanced inoperable disease, who received radical RT or RT + CT (CT- chemotherapy).
In 1 group the specimens of blood we collected before surgery and 1-2 month after. In 2 group - before palliative treatment and in group 3 before radical treatment and one month after completion treatment. To compare to serum specimens from patients with lung cancer was obtained plasma from healthy volunteers.
Serum separation and Raman spectroscopy analysis:
A single 2 ml heparinised peripheral blood sample was centrifuges to get serum specimens. The Raman spectra (RS) of the solid residues from serum samples were measurement by placing 10µl of serum from the aliquots onto an aluminium substrate and allowed to dry for at least 30 min. The Raman system (Renishaw inVia Microscope integrated with Leica microscope) was calibrated with a silicon standard using the Raman peak at 520 cm-1. Multiple scans were conducted on the solid residue by moving the substrate on an X - Y stage. The wavelength of excitation was 785 nm and the laser beam was focused on the surface of the sample with a 50x objective. The radius on the beam was 3.0 µm and the laser power irradiation over the sample was 5mW. Each spectrum was taken with an exposure of 30s, 10 accumulation and collected in the region from 400 to 1540 cm-1.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Lubuskie
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Zielona Góra, Lubuskie, Polsko, 65-417
- Park Naukowo-Technologiczny Uniwersytetu Zielonogórskiego Sp. z o.o.
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- confirmed lung cancer
- WHO 0-2
- 6 month after chemotherapy in palliative patients
Exclusion Criteria:
- double cancer
- another cancer
- chemotherapy in radical patients
- prior external beam radiation in an interview with the patient
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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1-patients with operating tumor
1- 23 patients with operating tumor; In 1 group the specimens of blood will be collected day before surgery and 1-2 month after surgery. Will be collected: histopathology outcomes - type carcinoma, tumore volume and before surgery: morphology and coagulation system. Will be assessed correlation between mentioned above factors and concentration of P-selectin. Will be compared concentration of P-selectin in 3 groups of patients. Serum separation and Raman spectroscopy analysis. A single 2 ml heparinised peripheral blood sample was centrifuges to get serum specimens. The Raman spectra (RS) of the solid residues from serum samples were measurement by placing 10µl of serum from the aliquots onto an aluminium substrate and allowed to dry for at least 30 min. |
A single 2 ml heparinised peripheral blood sample was centrifuges to get serum specimens.
Serum separation and Raman spectroscopy analysis:
|
|
2-patients with advanced desease.
2- ten patients with advanced and metastatic disease who received palliative RT (RT - radiotherapy); In 2 group - the specimens of blood we collected before palliative treatment-radiotherapy. Will be collected: histopathology outcomes - type carcinoma, morphology. Will be assessed correlation between mentioned factors and concentration of P-selectin. Will be compared concentration of P-selectin in 3 groups of patients. Serum separation and Raman spectroscopy analysis: A single 2 ml heparinised peripheral blood sample was centrifuges to get serum specimens.The Raman spectra (RS) assessed as above |
A single 2 ml heparinised peripheral blood sample was centrifuges to get serum specimens.
Serum separation and Raman spectroscopy analysis:
|
|
3-patients with inoperable disease
In group 3 - the specimens of blood we collected before radical treatment and one month after completion treatment. Will be collected: histopathology outcomes - type carcinoma, morphology. Will be assessed correlation between mentioned above factors and concentration of P-selectin. Will be compared concentration of P-selectin in 3 groups of patients. Serum separation and Raman spectroscopy analysis: A single 2 ml heparinised peripheral blood sample was centrifuges to get serum specimens. The Raman spectra (RS) of the solid residues from serum samples were measurement by placing 10µl of serum from the aliquots onto an aluminium substrate and allowed to dry for at least 30 min. |
A single 2 ml heparinised peripheral blood sample was centrifuges to get serum specimens.
Serum separation and Raman spectroscopy analysis:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Assessment of the concentration of P-selectin in 3 groups in lung cancer patients and compared to the healthy participants.
Časové okno: The study started from November 2015 and will be completed in May 2016. The end of the study will be July 2016.Data will be presented up to 1 year.
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Assessment of the concentration of P-selectin in 3 groups in lung cancer patients and compare the concentration of P-selectin depends on tumor volume.Comparison between 3 groups and in the end, compared to the healthy population
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The study started from November 2015 and will be completed in May 2016. The end of the study will be July 2016.Data will be presented up to 1 year.
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Edyta I Wolny-Rokicka, MD.PhD, Clinicial Hospital in Zielona Góra,Radiotherapy Department ul Zyty 26, Zielona Góra, Poland
Publikace a užitečné odkazy
Obecné publikace
- Blann AD, Lip GY. Hypothesis: is soluble P-selectin a new marker of platelet activation? Atherosclerosis. 1997 Feb 10;128(2):135-8. doi: 10.1016/s0021-9150(96)05980-1. No abstract available.
- Bendas G, Borsig L. Cancer cell adhesion and metastasis: selectins, integrins, and the inhibitory potential of heparins. Int J Cell Biol. 2012;2012:676731. doi: 10.1155/2012/676731. Epub 2012 Feb 12.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Science and Technology Park,
- 2/07/2015 (Identifikátor registru: bioethical commission)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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