Analysis of P-Selectin Expression on Platelets of Blood From Lung Cancer Patients

Lung Cancer Clinical Trial

Official title:

Analysis of P-selectin Expression on Platelets of Blood Between Serum Samples From Lung Cancer and Healthy Individuals by Using Raman Spectroscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02758678
• Other study ID #: Science and Technology Park,
• Secondary ID: 2/07/2015
• Status: Completed
• Phase: N/A
• First received: April 18, 2016
• Last updated: October 17, 2016
• Start date: November 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Science and Technology Park, Center of Innovation Technologies for Human Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Biological:
• A single 2 ml heparinised peripheral blood sample
A single 2 ml heparinised peripheral blood sample was centrifuges to get serum specimens. Serum separation and Raman spectroscopy analysis:

Locations

Country	Name	City	State
Poland	Park Naukowo-Technologiczny Uniwersytetu Zielonogórskiego Sp. z o.o.	Zielona Góra	Lubuskie

Sponsors (2)

Lead Sponsor	Collaborator
Science and Technology Park, Center of Innovation Technologies for Human Health	University in Zielona Góra

Country where clinical trial is conducted

Poland, 

References & Publications (2)

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. — View Citation

Blann AD, Lip GY. Hypothesis: is soluble P-selectin a new marker of platelet activation? Atherosclerosis. 1997 Feb 10;128(2):135-8. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the concentration of P-selectin in 3 groups in lung cancer patients and compared to the healthy participants.	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	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.	Yes